JBJS | The Effect of Surgery for Rotator Cuff Disease on General Health Status : Results of a Prospective Trial*

The Journal of Bone & Joint Surgery, Volume 82, Issue 7

Articles | July 01, 2000

The Effect of Surgery for Rotator Cuff Disease on General Health Status : Results of a Prospective Trial*

Michael D. McKee, M.D., F.R.C.S.(C)†; Daniel J. Yoo, B.Sc.†

Investigation performed at the Division of Orthopaedics, Department of Surgery, Upper Extremity Reconstructive Service, St. Michael's Hospital and the University of Toronto, Toronto, Ontario, Canada
*No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article. No funds were received in support of this study.
†Division of Orthopaedics, Department of Surgery, Upper Extremity Reconstructive Service, St. Michael's Hospital and the University of Toronto, 55 Queen Street East, Suite 800, Toronto, Ontario M5C 1R6, Canada. E-mail address for M. D. McKee: mckee@the-wire.com.

The Journal of Bone & Joint Surgery. 2000; 82:970-970

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Abstract

Background: Previous studies of the effect of rotator cuff surgery have concentrated on limb-specific or surgeon-based outcome criteria. We conducted a prospective trial to determine the effect of surgery for rotator cuff disease on general health status.

Methods: Seventy-one patients (fifty of whom were men and twenty-one of whom were women) with a mean age of 56.1 years were enrolled in the study. In addition to routine clinical and radiographic evaluation, all patients completed the Short Form-36 (SF-36) health-status questionnaire and five limb-specific questionnaires preoperatively and at six, twelve, eighteen, and twenty-four months postoperatively. All patients had a standard open acromioplasty and resection of the subacromial bursa. Thirty-one patients had repair of an associated rotator cuff tear. Sixty-seven patients (94 percent) completed the study; the remaining four patients were lost to follow-up.

Results: The preoperative SF-36 scores for physical function (60.6, p = 0.02), role function-physical (20.8, p = 0.001), pain (38.6, p = 0.003), physical component summary (37.0, p = 0.001), and mental component summary (45.6, p = 0.02) were significantly decreased compared with normative data. The preoperative limb-specific scores also were low. At the time of the most recent follow-up evaluation, there was improvement that approached or reached significance both in the limb-specific scores (p Â£ 0.0026) and in the general-health-status scores for pain (p = 0.0001), role function-physical (p = 0.06), vitality (p = 0.01), and physical component summary (p = 0.01). The presence of a rotator cuff tear had a significant negative effect on limb-specific scores both preoperatively (p = 0.04) and postoperatively (p = 0.05). Although operative treatment of rotator cuff disease led to improved scores, patients who had filed a Workers' Compensation claim had lower limb-specific and SF-36 scores both preoperatively (p = 0.02 and p = 0.01, respectively) and postoperatively (p = 0.01 and p = 0.005, respectively).

Conclusions: Surgery for chronic rotator cuff disease reliably and significantly improves general health status.

Figures in this Article

Introduction

Introduction | Materials and Methods | Results | Discussion | References

Previous reports have described the effectiveness of surgical intervention for the treatment of rotator cuff disease that has not responded to conservative care^{4,5,8-10,15,17}. The outcome measures used in most studies have been joint or limb-specific^1,2,30,35. Those studies clearly demonstrated the debilitating effect that rotator cuff disease has on limb function. Recently, it has been shown that a variety of pathological conditions of the shoulder, including rotator cuff impingement, have a negative effect on general health status as determined with use of validated patient-oriented questionnaires^{3,13,14,29,31,36,37}. Improvements in general health status following orthopaedic intervention have been well described, although many reports have lacked preoperative data or have had a short duration of follow-up^{6,7,19,20,25-28}. Recently, the effectiveness of arthroscopic shoulder surgery was demonstrated by Gartsman et al., but patients who were receiving Workers' Compensation were excluded from that study¹³. Little is known regarding the impact of open rotator cuff surgery on general health status.

It is not clear whether general-health-status instruments are as sensitive to changes in a specific orthopaedic condition as limb or disease-specific instruments are. It also is not clear which components of these outcome measures are most responsive².

As competition for the health-care dollar increases and as economists and politicians focus on the cost-effectiveness and efficacy of various medical and surgical interventions, generic health-status instruments can be used to evaluate the effectiveness of various treatments and to compare interventions across a wide range of diseases^14,40. The importance of the development, validation, and use of these tools has been well described in the orthopaedic literature^26-29.

In the present prospective study, we sought to determine the effect of surgery for rotator cuff disease on general health status as measured with the Short Form-36 (SF-36). We also sought to determine the prognostic factors associated with outcome, the time-course of improvement following surgical intervention, and which components of general health status are most likely to be affected.

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Fig. 1:: Preoperative and postoperative scores for the SPADI (Shoulder Pain and Disability Index).

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Fig. 2:: Preoperative and postoperative scores for the SSRS (Subjective Shoulder-Rating Scale).

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Fig. 3:: Preoperative and postoperative scores for the SST (Simple Shoulder Test).

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Fig. 4:: Preoperative and postoperative scores for the M-ASES (Modified American Shoulder and Elbow Surgeons) Patient Self-Evaluation Form.

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Fig. 5:: Preoperative and postoperative scores for the SSI (Shoulder Severity Index).

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Fig. 6:: Preoperative and postoperative scores for the role function-physical component of the Short Form-36 (SF-36) questionnaire.

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Fig. 7:: Preoperative and postoperative scores for the pain component of the Short Form-36 (SF-36) questionnaire.

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Fig. 8:: Preoperative and postoperative scores for the physical component summary of the Short Form-36 (SF-36) questionnaire.

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Fig. 9:: Preoperative and postoperative scores for the mental component summary of the Short Form-36 (SF-36) questionnaire.

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TABLE I: Preoperative and Postoperative Limb-Specific Scores*

*The p values pertain to the comparison between the postoperative score at each time-point and the preoperative score.SPADI = Shoulder Pain and Disability Index, SSRS = Subjective Shoulder-Rating Scale, SST = Simple Shoulder Test, M-ASES = Modified American Shoulder and Elbow Surgeons Patient Self-Evaluation Form, and SSI = Shoulder Severity Index.

Outcome Measure	Preoperative	Postoperative
6 Mos.	12 Mos.	18 Mos.	24 Mos.
SPADI
Score (points)	34.2	69.7	74.2	69.9	74.5
P value		0.0001	0.0001	0.0001	0.0001
SSRS
Score (points)	47.3	58.6	71.8	70.4	72.9
P value		0.147	0.0001	0.0001	0.0001
SST
Score (points)	31.6	54.5	60.9	53.1	61.8
P value		0.0042	0.0001	0.0007	0.0001
M-ASES
Score (points)	46.1	70.4	59.5	59.8	67.3
P value		0.0075	0.0718	0.0516	0.0026
SSI
Score (points)	45.6	78.9	75.2	70.5	75.8
P value		0.0001	0.0001	0.0001	0.0001

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TABLE I: Preoperative and Postoperative Limb-Specific Scores*

Outcome Measure	Preoperative	Postoperative
6 Mos.	12 Mos.	18 Mos.	24 Mos.
SPADI
Score (points)	34.2	69.7	74.2	69.9	74.5
P value		0.0001	0.0001	0.0001	0.0001
SSRS
Score (points)	47.3	58.6	71.8	70.4	72.9
P value		0.147	0.0001	0.0001	0.0001
SST
Score (points)	31.6	54.5	60.9	53.1	61.8
P value		0.0042	0.0001	0.0007	0.0001
M-ASES
Score (points)	46.1	70.4	59.5	59.8	67.3
P value		0.0075	0.0718	0.0516	0.0026
SSI
Score (points)	45.6	78.9	75.2	70.5	75.8
P value		0.0001	0.0001	0.0001	0.0001

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TABLE II: Preoperative and Postoperative SF-36 Scores*

*The p values pertain to the comparison between the postoperative score at each time-point and the preoperative score. SF-36 = Short Form-36.

SF-36 Component	Preoperative	Postoperative
6 Mos.	12 Mos.	18 Mos.	24 Mos.
Physical function
Score (points)	60.6	72.7	62.8	73.2	66.8
P value		0.2201	0.7504	0.0349	0.3351
Social function
Score (points)	65.3	76.1	77.8	77.2	79.5
P value		0.1957	0.1034	0.0758	0.0373
Role function-physical
Score (points)	20.8	42.3	50.0	54.0	42.1
P value		0.2221	0.0153	0.0028	0.0615
Role function-emotional
Score (points)	39.2	51.9	37.5	55.3	54.0
P value		0.3237	0.8743	0.0829	0.1084
Mental health
Score (points)	67.9	75.1	77.5	71.2	66.8
P value		0.4675	0.1065	0.5589	0.2067
Vitality
Score (points)	52.3	64.6	57.8	60.5	66.8
P value		0.1019	0.4168	0.1432	0.0105
Pain
Score (points)	38.6	65.8	65.3	60.3	66.1
P value		0.0011	0.0002	0.0007	0.0001
General health perception
Score (points)	68.1	72.7	70.3	66.1	68.1
P value		0.7561	0.7366	0.7829	0.3200

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TABLE II: Preoperative and Postoperative SF-36 Scores*

*The p values pertain to the comparison between the postoperative score at each time-point and the preoperative score. SF-36 = Short Form-36.

SF-36 Component	Preoperative	Postoperative
6 Mos.	12 Mos.	18 Mos.	24 Mos.
Physical function
Score (points)	60.6	72.7	62.8	73.2	66.8
P value		0.2201	0.7504	0.0349	0.3351
Social function
Score (points)	65.3	76.1	77.8	77.2	79.5
P value		0.1957	0.1034	0.0758	0.0373
Role function-physical
Score (points)	20.8	42.3	50.0	54.0	42.1
P value		0.2221	0.0153	0.0028	0.0615
Role function-emotional
Score (points)	39.2	51.9	37.5	55.3	54.0
P value		0.3237	0.8743	0.0829	0.1084
Mental health
Score (points)	67.9	75.1	77.5	71.2	66.8
P value		0.4675	0.1065	0.5589	0.2067
Vitality
Score (points)	52.3	64.6	57.8	60.5	66.8
P value		0.1019	0.4168	0.1432	0.0105
Pain
Score (points)	38.6	65.8	65.3	60.3	66.1
P value		0.0011	0.0002	0.0007	0.0001
General health perception
Score (points)	68.1	72.7	70.3	66.1	68.1
P value		0.7561	0.7366	0.7829	0.3200

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TABLE III: Effect of Rotator Cuff Tear on Limb-Specific and General-Health-Status Scores

*SPADI = Shoulder Pain and Disability Index, and SF-36 = Short Form-36.

Outcome Measure*	Preoperative			Postoperative
Score (points)		P Value	Score (points)		P Value
Tear (N = 31)	No Tear (N = 40)	Tear (N = 30)	No Tear (N = 37)
SPADI	31.7	36.1	0.04	70.8	77.5	0.05
SF-36
Physical component summary	36.2	37.6	0.51	42.4	44.6	0.25
Mental component summary	44.2	46.7	0.32	46.9	49.1	0.46

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TABLE III: Effect of Rotator Cuff Tear on Limb-Specific and General-Health-Status Scores

*SPADI = Shoulder Pain and Disability Index, and SF-36 = Short Form-36.

Outcome Measure*	Preoperative			Postoperative
Score (points)		P Value	Score (points)		P Value
Tear (N = 31)	No Tear (N = 40)	Tear (N = 30)	No Tear (N = 37)
SPADI	31.7	36.1	0.04	70.8	77.5	0.05
SF-36
Physical component summary	36.2	37.6	0.51	42.4	44.6	0.25
Mental component summary	44.2	46.7	0.32	46.9	49.1	0.46

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TABLE IV: Effect of Workers' Compensation Status on Limb-Specific and General-Health-Status Scores

*SPADI = Shoulder Pain and Disability Index, and SF-36 = Short Form-36.†WCB = Workers' Compensation Board.

Outcome Measure*	Preoperative			Postoperative
Score (points)		P Value	Score (points)		P Value
No WCB Claim† (N = 48)	WCB Claim †(N = 23)	No WCB Claim †(N = 45)	WCB Claim †(N = 22)
SPADI	36.4	29.7	0.02	80.8	61.7	0.01
SF-36
Physical component summary	38.9	32.9	0.02	45.8	38.7	0.005
Mental component summary	47.6	41.4	0.01	50.7	42.4	0.01

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TABLE IV: Effect of Workers' Compensation Status on Limb-Specific and General-Health-Status Scores

*SPADI = Shoulder Pain and Disability Index, and SF-36 = Short Form-36.†WCB = Workers' Compensation Board.

Outcome Measure*	Preoperative			Postoperative
Score (points)		P Value	Score (points)		P Value
No WCB Claim† (N = 48)	WCB Claim †(N = 23)	No WCB Claim †(N = 45)	WCB Claim †(N = 22)
SPADI	36.4	29.7	0.02	80.8	61.7	0.01
SF-36
Physical component summary	38.9	32.9	0.02	45.8	38.7	0.005
Mental component summary	47.6	41.4	0.01	50.7	42.4	0.01

Materials and Methods

Introduction | Materials and Methods | Results | Discussion | References

Inclusion and Exclusion Criteria

Between December 1993 and May 1995, seventy-one consecutive patients were enrolled in a prospective trial to investigate the effect of surgery for rotator cuff disease (defined as impingement or tearing, or both) on general health status. All procedures were performed by the senior one of us (M. D. McK.). The clinical diagnosis of rotator cuff disease was made on the basis of patient history (pain with overhead work or activity, pain when sleeping on the involved shoulder, discomfort with internal rotation), physical findings (subacromial grinding or crepitus, tenderness in the anterior part of the acromion, positive impingement signs, limited terminal flexion or abduction, weak external rotation, supraspinatus or infraspinatus atrophy), and radiographic findings (acromial spurs, cystic or sclerotic changes at the greater tuberosity, inferior clavicular osteophytes). Patients were considered to be candidates for surgery if they had (1) a clinical diagnosis of rotator cuff disease, (2) shoulder symptoms that had been present for a minimum of six months, (3) a history of failure of conservative care, and (4) substantial relief of pain during abduction and flexion following an injection of local anesthetic into the subacromial space (a decrease of 5 points or more on a 10-point visual analog scale)³⁵. For the purposes of this study, an adequate course of conservative care was defined as treatment with at least three of the following: (1) physiotherapy, (2) anti-inflammatory medication, (3) injection of cortisone into the subacromial space, and (4) modification of work or overhead activity, or both.

All of the patients who were entered into the trial fulfilled all four criteria for surgical intervention. Patients with rotator cuff tear arthropathy, instability-associated impingement, glenohumeral arthritis, or other pathological problems involving the shoulder were excluded from the study. Eight patients who had a massive, irreparable rotator cuff tear (more than five centimeters in size) were excluded from the study. Patients who were unable to complete the questionnaires because of a psychological disorder, illiteracy, or lack of command of the English language also were excluded.

Evaluation

Preoperatively, all patients were evaluated with a complete history, physical examination, and radiographs (including a transaxillary view). Patients who were involved in an active Workers' Compensation Board claim were identified. Ancillary investigations, such as magnetic resonance imaging or arthrography of the shoulder, were performed on an individualized basis and were not done routinely. All patients completed five limb-specific questionnaires, including the Simple Shoulder Test (SST)²⁴, the Shoulder Pain and Disability Index (SPADI)³⁴, the Subjective Shoulder-Rating Scale (SSRS)²¹, the Modified American Shoulder and Elbow Surgeons (M-ASES) Patient Self-Evaluation Form³³, and the Shoulder Severity Index (SSI)³² prior to surgery^2,12,23. For the purpose of comparison, all scores were transformed so that 100 points indicated the most positive state of health². During the same sitting, all patients also completed the Short Form-36 (SF-36) general-health-status questionnaire^38,39. The same five shoulder questionnaires and the SF-36 questionnaire were completed at the time of routine clinical follow-up examinations at six, twelve, eighteen, and twenty-four months postoperatively. Demographic data regarding the patient's type of work, level of education, marital status, and medical comorbidities was also collected. A comorbidity was defined as a chronic condition for which the patient had received active treatment from a physician during the year prior to surgery.

The preoperative questionnaire package was completed in the office or clinic at the time of enrollment in the study. Postoperative questionnaires usually were completed while the patient waited in the clinic for medical assessment. If sufficient time was not available for completion during the clinic visit, the patient could take the questionnaire home and return it later; this occurred approximately 10 percent of the time. Completion of the questionnaire package took approximately thirty minutes. Patients were enthusiastic about completing the package once its purpose had been explained to them; they did not require persuasion or prompting in order to complete it, and many added spontaneous written comments. No telephone interviews were conducted. During the first administration of the questionnaire package, an interviewer was available to answer any questions that the patient might have.

Surgical Technique

All patients underwent a standard open acromioplasty, which was performed through a deltoid-splitting approach with the patient in the beach-chair (semi-sitting) position. Following a two-step anterior acromioplasty, the subacromial bursa was excised and the distal part of the clavicle was resected, with removal of ten millimeters of bone and preservation of the coracoclavicular ligaments. We believe that degenerative changes in the acromioclavicular joint are closely related to, and may contribute to, rotator cuff impingement. Excision of the distal part of the clavicle ensures complete rotator cuff decompression, relieves pain at the site of a degenerative acromioclavicular joint, and improves exposure. The rotator cuff was inspected³⁵. Forty patients had inflammation, edema, or thinning of the rotator cuff without any visible tear or defect. Thirty-one patients had a rotator cuff tear that was repaired at the time of surgery; there were ten small, twelve medium, nine large, and no massive tears¹⁸. All tears were debrided to healthy tissue and were repaired with use of standard mobilization and advancement techniques. Most tears were repaired into a trough in bone at the articular margin. The deltoid muscle was repaired with use of interrupted, nonabsorbable sutures that were placed in a horizontal mattress fashion, and the subcutaneous tissue and the skin were then closed in a standard fashion.

Rehabilitation

Postoperatively, a sling was applied for comfort. Pendulum exercises were begun on the first postoperative day under the supervision of a physiotherapist. Active-assisted flexion and abduction exercises were begun two weeks postoperatively. To protect the integrity of the deltoid repair, full active exercises were restricted until the sixth postoperative week and unrestricted exercises, including resisted motion, were begun at eight weeks. The patient was allowed to return to work as early as possible, depending on the physical demands of his or her occupation, the presence or absence of a rotator cuff tear, and the progression of the rehabilitation.

Statistical Analysis

Statistical analysis was performed with use of the SAS software package (SAS Institute, Cary, North Carolina). Comparisons between preoperative and postoperative scores were performed at each time-point for each of the five limb-specific rating scales and the SF-36 questionnaire with use of a Student two-sample t test. A p value of 0.05 or less was considered significant. The normality of the data was tested with use of the Shapiro-Wilk statistic; a value of W > 0.05 was obtained, indicating a normal distribution of scores. The preoperative SF-36 scores for the patients in the study group were compared with normal (control) values after the calculation of z values. To assess the effect of various prognostic variables, data was subdivided and pooled in relation to each variable and evaluated in a similar fashion, with a p value of 0.05 or less considered significant.

Results

Introduction | Materials and Methods | Results | Discussion | References

Demographic Data

Seventy-one patients (fifty of whom were men and twenty-one of whom were women) with a mean age of 56.1 years (range, thirty-two to seventy-eight years) were enrolled in the trial. The patients had had shoulder symptoms for a mean of 10.6 months (range, six to sixty-one months). All had had a failure of an adequate course of conservative care, as described previously.

Twenty-three patients (thirteen physical or manual workers, eight office or professional workers, and two full-time students) had filed a Workers' Compensation Board claim involving the shoulder. The remaining forty-eight patients (nineteen physical or manual workers, fifteen office or professional workers, ten individuals who were retired or unemployed, and four full-time students) had not filed such a claim. With the numbers available for study, we could detect no significant difference between the two groups with regard to the number of physical or manual workers (40 percent [nineteen] of the forty-eight patients who had not filed a claim performed physical or manual work compared with 57 percent [thirteen] of the twenty-three who had filed a claim; p = 0.18). Similarly, we could detect no significant difference between the two groups with regard to marital status (71 percent [thirty-four] of the forty-eight patients who had not filed a claim were married or had a common-law spouse compared with 70 percent [sixteen] of the twenty-three who had filed a claim; p = 0.91) or the presence of a medical comorbidity (27 percent [thirteen] of the forty-eight patients who had not filed a claim had a comorbidity compared with 22 percent [five] of the twenty-three who had filed a claim; p = 0.63). Thirty-eight percent (eighteen) of the forty-eight patients who had not filed a claim had graduated from a college or university compared with 26 percent (six) of the twenty-three who had filed a claim (p = 0.41). Data on mean household income was not available.

Four patients did not complete the study. Their demographic characteristics (age, occupation, educational level, medical comorbidity, marital status, and baseline scores) were not significantly different from those of the patients who completed the study. Two of the four patients had moved out of the country and could not be located. One of these two patients had a 14-point improvement in the SF-36 physical component summary score at twelve months, and the other had a 12-point improvement at six months; these were the last available scores for these individuals. The third patient who did not complete the study was subjectively pleased with the result of the operation but refused to complete the postoperative forms because of a pending legal claim. The fourth patient withdrew from the study because he was diagnosed with systemic lymphoma nine months postoperatively. He had a 9-point improvement in the physical component summary score at six months, and he was subjectively satisfied with the result of the operation. Complete preoperative and postoperative data was available for the remaining sixty-seven patients (94 percent). All sixty-seven patients were followed at six-month intervals for two years after the operation.

Preoperative Scores

Preoperatively, all patients had significant impairment of upper extremity function as determined with use of the five limb-specific measures (Fig. 1,Fig. 2,Fig. 3,Fig. 4, and Fig. 5 and Table I). The mean SPADI score was 34.2 (range, 21 to 75), the mean SSRS score was 47.3 (range, 33 to 87), the mean SST score was 31.6 (range, 15 to 58), the mean M-ASES score was 46.1 (range, 9 to 63), and the mean SSI score was 45.6 (range, 20 to 70). All patients also demonstrated impairment of general health status as measured with use of the SF-36 questionnaire (Fig. 6,Fig. 7,Fig. 8, and Fig. 9 and Table II). The mean physical component summary score was 37.0, and the mean mental component summary score was 45.6; both of these values were significantly lower than control values (p = 0.001 and p = 0.02, respectively)¹⁴. While the scores for pain (mean, 38.6; range, 0 to 90), role function-physical (mean, 20.8; range, 0 to 95), and physical function (mean, 60.6; range, 0 to 90) were the most severely affected (p = 0.003, p = 0.001, and p = 0.02, respectively), significant decreases also were seen in the other components of the SF-36.

Complications

Four patients (6 percent) had a postoperative complication, and two (3 percent) required a reoperation. One patient had a wound infection that necessitated surgical drainage and dè¡²idement, and one patient required total shoulder arthroplasty because of rapid progression of previously minimal osteoarthritic changes. Two patients had a documented rerupture of the rotator cuff but were satisfied with the level of pain relief and declined additional surgical intervention.

Postoperative Scores

The postoperative scores were significantly higher than the preoperative scores. The limb-specific scores showed the greatest magnitude of improvement, and most were significantly improved at six, twelve, eighteen, and twenty-four months postoperatively. Scores tended to plateau by twelve to eighteen months postoperatively (Fig. 1,Fig. 2,Fig. 3,Fig. 4, and Fig. 5). When the preoperative SF-36 scores were compared with the final (twenty-four-month) postoperative scores, improvement was observed in a number of categories: the physical component summary score improved from 37.0 to 43.6 (p = 0.01), the role function-physical score improved from 20.8 to 42.1 (p = 0.06), the vitality score improved from 52.3 to 66.8 (p = 0.01), and the pain score improved from 38.6 to 66.1 (p = 0.0001). The greatest magnitudes of improvement were seen in the pain and role function-physical categories (Fig. 6 and Fig. 7 and Table II).

Prognostic Variables

We assessed the effect of a number of variables on the preoperative and postoperative scores that were determined with use of the SF-36 questionnaire and the limb-specific instruments. For the purposes of this analysis, outcome was determined by comparing the preoperative score and the final (twenty-four-month) postoperative score. We detected no relationship between outcome and the variables of age (SF-36, p = 0.55; limb-specific measures, p = 0.43 to 0.65), gender (SF-36, p = 0.87; limb-specific measures, p = 0.78 to 0.89), side of involvement (SF-36, p = 0.41; limb-specific measures, p = 0.59 to 0.75), duration of symptoms (SF-36, p = 0.23; limb-specific measures, p = 0.33 to 0.49), or type of occupation (physical or sedentary) (SF-36, p = 0.14; limb-specific measures, p = 0.23 to 0.35). Two variables were found to have a significant effect on the scores, as demonstrated in Table III and Table IV (using one typical limb-specific measure [the SPADI] and the physical component summary and mental component summary of the SF-36). The presence of a rotator cuff tear had a negative effect on the limb-specific scores both preoperatively (p = 0.04) and postoperatively (p = 0.05) but did not have a significant effect on the general-health-status scores (Table III). A positive Workers' Compensation status had a negative effect on the limb-specific and general-health-status scores both preoperatively (p Â£ 0.02) and postoperatively (p Â£ 0.02) (Table IV). Although the physical component summary scores for patients who had filed a Workers' Compensation Board claim showed a similar magnitude of increase compared with the scores for patients who had not filed such a claim (p = 0.32), the mental component summary scores did not improve significantly in either group.

Discussion

Introduction | Materials and Methods | Results | Discussion | References

Numerous reports in the orthopaedic literature have documented the effectiveness of operative treatment of rotator cuff disease that is recalcitrant to conservative care^{1,2,4,5,8-10,15,17,30,35}. Those studies have been criticized because of their retrospective nature, poor follow-up rates, lack of functional outcome data, and exclusive use of limb or disease-specific outcome measures. As the evaluation of the results of medical or surgical intervention has become more sophisticated, the inadequacy of previous outcome measures that rely solely on physician assessment or on surrogate measures (such as radiographic findings) has become apparent^3,23,26-29. As a result, investigators have developed a number of patient-oriented general-health-status measures in an effort to be more responsive to the factor that is of greatest importance - that is, the patient's perception of the impact of treatment on function and quality of life. One of the most widely used instruments has been the SF-36, which has been shown to be valid (able to measure what it is supposed to measure), reliable (able to yield consistent measurements at different times and in different settings), and responsive (able to measure a change in condition)^38,39. The efficacy of a variety of orthopaedic interventions, including hip, shoulder, and knee arthroplasties, has been demonstrated with use of the SF-36 in a prospective fashion^12,25,28,29.

A number of recent studies have demonstrated that shoulder pathology has a deleterious effect on both limb-specific and general-health-status scores^13,14,25. It is clear that shoulder pathology, including rotator cuff disease, can have a significant negative impact on quality of life and general health status and that this impact may not be limited to the so-called physical components of such outcome measures. Matsen, in a prospective study, demonstrated that total shoulder arthroplasty has a beneficial effect on osteoarthritis of the shoulder, although the follow-up period was short²⁹. Similarly, Gartsman et al. documented that arthroscopic repair of rotator cuff tears has a beneficial effect on general health status as measured with the SF-36¹³. The present study provides additional information in that it focused on the effect of open surgical treatment of rotator cuff disease (defined as impingement or tearing, or both). By determining the scores at four separate postoperative intervals (ranging from six months to two years following surgery), we were able to examine the time-course of improvement following operative treatment. In most patients, improvement plateaued by twelve to eighteen months postoperatively (Figs. 1 through 9).

Preoperatively, we found a significant level of impairment as measured with use of limb-specific outcome tools (the SPADI, SSRS, SST, M-ASES, and SSI), as has been reported in previous studies^2,14,23,36. Highly significant improvement in the scores was seen postoperatively (p = 0.0001 to 0.0026). The responsiveness of limb-specific measures to surgical intervention has been documented previously^2,12,37. In the present study, we found that surgical intervention also had an effect on general-health-status scores, several of which showed significant improvement. While Gartsman et al. found improvements in most categories of the SF-36, including mental components such as vitality and role function-emotional¹³, the improvements in the present study were limited to physical components. This may have been due to differences between the studies with regard to the indication for the operation (impingement or tearing, or both, compared with tearing only), the nature of the operative procedure (open compared with arthroscopic repair), and, most importantly, the patient population (inclusion compared with exclusion of patients who had filed a Workers' Compensation claim). The mean increase in the SF-36 pain score in the present study (27 points) was less than that in the study by Gartsman et al. (40 points).

The use of a general-health-status instrument allows for comparisons of improvement following a wide range of medical interventions. We previously reported that the SF-36 pain score improved a mean of 28 points (from 33 points preoperatively to 61 points postoperatively) in patients managed with Ilizarov reconstruction because of a posttraumatic lower-limb deformity²⁵. Matsen reported a mean improvement of 26 points in the SF-36 pain score in patients managed with total shoulder arthroplasty because of glenohumeral arthritis²⁹. It seems intuitive that the magnitude of improvement after successful treatment of shoulder arthritis (26 points) or an infected tibial nonunion (28 points) would be greater than that after open (27 points) or arthroscopic (40 points) rotator cuff repair, but this was not reflected by the SF-36 pain scores. The reason for this finding is unclear, and many factors are certainly involved. It has been shown that there are significant differences between patients' and surgeons' assessments of outcome following orthopaedic procedures²³.

Compensation for work-related injuries has been associated with a poor outcome following surgical intervention and with delayed recovery leading to longer time-periods before return to work^4,11,31. Recently, Viola et al., in a study of patients with a variety of shoulder disorders, showed that Workers' Compensation status has an effect on general health status (including mental components) prior to any surgical intervention³⁷. Our results parallel those findings and demonstrate that this phenomenon is also seen postoperatively. Since the demographic characteristics of the patients who had filed a Workers' Compensation claim were similar to those of the patients who had not, we believe that any differences between these groups were related to the compensation status. While both groups had improvement in the physical component summary score, patients who were involved in a compensation claim started with a lower score and thus ended with a lower score. The mental component summary score did not improve significantly in either group. Since most surgeons are familiar with patients receiving Workers' Compensation who remain dissatisfied despite a technically successful shoulder procedure, this information is important for a number of reasons. In the future, it may help the surgeon (1) to identify individuals whose shoulder problem is only one component of their dissatisfaction, (2) to identify individuals who are less likely to have a successful result, (3) to provide a more accurate prognosis for those undergoing surgery, and (4) to focus treatment on other aspects of patient care.

It also has been well documented that a frank rotator cuff tear (as opposed to inflammation, edema, or thinning of the cuff without a tear) has a deleterious effect on function^{9,10,16,18,22}. In the present study, the presence of a tear affected the limb-specific scores but did not seem to influence the general-health-status scores. This may be because general-health-status questionnaires lack the sensitivity to distinguish between these two closely related conditions.

The use of health-status questionnaires is convenient, inexpensive, and straightforward. Patients generally enjoy being asked their opinion regarding the relative success or failure of a medical intervention, and many of the patients in the present study provided additional written comments on their forms. Although health-status questionnaires may not be as responsive as limb or disease-specific instruments, they can be administered over the telephone or by mail and thus can eliminate the requirement for extensive follow-up. The information that is obtained may provide a better picture of the patient's assessment of a given medical intervention than is possible with the use of a standard history and physical examination; this information can be used both by research groups and by surgeons who wish to provide their patients with the clearest possible picture of the potential risks and benefits of a potential operation.

In summary, we found that recalcitrant rotator cuff disease had a significant effect on both limb-specific and general-health-status scores. Patients who had filed a Workers' Compensation claim had significantly lower limb-specific and general-health-status scores than those who had not, a finding that persisted postoperatively. As has been previously described in other areas of orthopaedic intervention, surgery had a beneficial effect not only on the anatomical area of interest but also on the general health status and the quality of life of the patient. Surgery for chronic rotator cuff disease reliably and significantly improves overall health status.

References

Introduction | Materials and Methods | Results | Discussion | References

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Hawkins, R. J.; Brock, R. M.; Abrams, J. S.; and Hobeika, P.: Acromioplasty for impingement with an intact rotator cuff. J. Bone and Joint Surg.,70-B(5): 795-797, 1988.70-B(5)795 1988

Iannotti, J. P.; Bernot, M. P.; Kuhlman, J. R.; Kelley, M. J.; and Williams, G. R.: Postoperative assessment of shoulder function: a prospective study of full-thickness rotator cuff tears. J. Shoulder and Elbow Surg.,5: 449-457, 1996.5449 1996

Johanson, N. A.; Charlson, M. E.; Szatrowski, T. P.; and Ranawat, C. S.: A self-administered hip-rating questionnaire for the assessment of outcome after total hip replacement. J. Bone and Joint Surg.,74-A: 587-597, April 1992.74-A587 1992

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Kuhlman, J. R.; Iannotti, J. P.; Kelly, M. J.; Reigler, F. X.; Gevaert, M. L.; and Ergin, T. M.: Isokinetic and isometric measurement of strength of external rotation and abduction of the shoulder. J. Bone and Joint Surg.,74-A: 1320-1333, Oct 1992.74-A1320 1992

Lieberman, J. R.; Dorey, F.; Shekelle, P.; Schumacher, L.; Thomas, B. J.; Kilgus, D. J.; and Finerman, G. A.: Differences between patients' and physicians' evaluations of outcome after total hip arthroplasty. J. Bone and Joint Surg.,78-A: 835-838, June 1996.78-A835 1996

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Fig. 1:: Preoperative and postoperative scores for the SPADI (Shoulder Pain and Disability Index).

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Fig. 2:: Preoperative and postoperative scores for the SSRS (Subjective Shoulder-Rating Scale).

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Fig. 3:: Preoperative and postoperative scores for the SST (Simple Shoulder Test).

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Fig. 4:: Preoperative and postoperative scores for the M-ASES (Modified American Shoulder and Elbow Surgeons) Patient Self-Evaluation Form.

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Fig. 5:: Preoperative and postoperative scores for the SSI (Shoulder Severity Index).

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Fig. 6:: Preoperative and postoperative scores for the role function-physical component of the Short Form-36 (SF-36) questionnaire.

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Fig. 7:: Preoperative and postoperative scores for the pain component of the Short Form-36 (SF-36) questionnaire.

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Fig. 8:: Preoperative and postoperative scores for the physical component summary of the Short Form-36 (SF-36) questionnaire.

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Fig. 9:: Preoperative and postoperative scores for the mental component summary of the Short Form-36 (SF-36) questionnaire.

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TABLE I: Preoperative and Postoperative Limb-Specific Scores*

Outcome Measure	Preoperative	Postoperative
6 Mos.	12 Mos.	18 Mos.	24 Mos.
SPADI
Score (points)	34.2	69.7	74.2	69.9	74.5
P value		0.0001	0.0001	0.0001	0.0001
SSRS
Score (points)	47.3	58.6	71.8	70.4	72.9
P value		0.147	0.0001	0.0001	0.0001
SST
Score (points)	31.6	54.5	60.9	53.1	61.8
P value		0.0042	0.0001	0.0007	0.0001
M-ASES
Score (points)	46.1	70.4	59.5	59.8	67.3
P value		0.0075	0.0718	0.0516	0.0026
SSI
Score (points)	45.6	78.9	75.2	70.5	75.8
P value		0.0001	0.0001	0.0001	0.0001

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TABLE I: Preoperative and Postoperative Limb-Specific Scores*

Outcome Measure	Preoperative	Postoperative
6 Mos.	12 Mos.	18 Mos.	24 Mos.
SPADI
Score (points)	34.2	69.7	74.2	69.9	74.5
P value		0.0001	0.0001	0.0001	0.0001
SSRS
Score (points)	47.3	58.6	71.8	70.4	72.9
P value		0.147	0.0001	0.0001	0.0001
SST
Score (points)	31.6	54.5	60.9	53.1	61.8
P value		0.0042	0.0001	0.0007	0.0001
M-ASES
Score (points)	46.1	70.4	59.5	59.8	67.3
P value		0.0075	0.0718	0.0516	0.0026
SSI
Score (points)	45.6	78.9	75.2	70.5	75.8
P value		0.0001	0.0001	0.0001	0.0001

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TABLE II: Preoperative and Postoperative SF-36 Scores*

*The p values pertain to the comparison between the postoperative score at each time-point and the preoperative score. SF-36 = Short Form-36.

SF-36 Component	Preoperative	Postoperative
6 Mos.	12 Mos.	18 Mos.	24 Mos.
Physical function
Score (points)	60.6	72.7	62.8	73.2	66.8
P value		0.2201	0.7504	0.0349	0.3351
Social function
Score (points)	65.3	76.1	77.8	77.2	79.5
P value		0.1957	0.1034	0.0758	0.0373
Role function-physical
Score (points)	20.8	42.3	50.0	54.0	42.1
P value		0.2221	0.0153	0.0028	0.0615
Role function-emotional
Score (points)	39.2	51.9	37.5	55.3	54.0
P value		0.3237	0.8743	0.0829	0.1084
Mental health
Score (points)	67.9	75.1	77.5	71.2	66.8
P value		0.4675	0.1065	0.5589	0.2067
Vitality
Score (points)	52.3	64.6	57.8	60.5	66.8
P value		0.1019	0.4168	0.1432	0.0105
Pain
Score (points)	38.6	65.8	65.3	60.3	66.1
P value		0.0011	0.0002	0.0007	0.0001
General health perception
Score (points)	68.1	72.7	70.3	66.1	68.1
P value		0.7561	0.7366	0.7829	0.3200

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TABLE II: Preoperative and Postoperative SF-36 Scores*

*The p values pertain to the comparison between the postoperative score at each time-point and the preoperative score. SF-36 = Short Form-36.

SF-36 Component	Preoperative	Postoperative
6 Mos.	12 Mos.	18 Mos.	24 Mos.
Physical function
Score (points)	60.6	72.7	62.8	73.2	66.8
P value		0.2201	0.7504	0.0349	0.3351
Social function
Score (points)	65.3	76.1	77.8	77.2	79.5
P value		0.1957	0.1034	0.0758	0.0373
Role function-physical
Score (points)	20.8	42.3	50.0	54.0	42.1
P value		0.2221	0.0153	0.0028	0.0615
Role function-emotional
Score (points)	39.2	51.9	37.5	55.3	54.0
P value		0.3237	0.8743	0.0829	0.1084
Mental health
Score (points)	67.9	75.1	77.5	71.2	66.8
P value		0.4675	0.1065	0.5589	0.2067
Vitality
Score (points)	52.3	64.6	57.8	60.5	66.8
P value		0.1019	0.4168	0.1432	0.0105
Pain
Score (points)	38.6	65.8	65.3	60.3	66.1
P value		0.0011	0.0002	0.0007	0.0001
General health perception
Score (points)	68.1	72.7	70.3	66.1	68.1
P value		0.7561	0.7366	0.7829	0.3200

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TABLE III: Effect of Rotator Cuff Tear on Limb-Specific and General-Health-Status Scores

*SPADI = Shoulder Pain and Disability Index, and SF-36 = Short Form-36.

Outcome Measure*	Preoperative			Postoperative
Score (points)		P Value	Score (points)		P Value
Tear (N = 31)	No Tear (N = 40)	Tear (N = 30)	No Tear (N = 37)
SPADI	31.7	36.1	0.04	70.8	77.5	0.05
SF-36
Physical component summary	36.2	37.6	0.51	42.4	44.6	0.25
Mental component summary	44.2	46.7	0.32	46.9	49.1	0.46

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TABLE III: Effect of Rotator Cuff Tear on Limb-Specific and General-Health-Status Scores

*SPADI = Shoulder Pain and Disability Index, and SF-36 = Short Form-36.

Outcome Measure*	Preoperative			Postoperative
Score (points)		P Value	Score (points)		P Value
Tear (N = 31)	No Tear (N = 40)	Tear (N = 30)	No Tear (N = 37)
SPADI	31.7	36.1	0.04	70.8	77.5	0.05
SF-36
Physical component summary	36.2	37.6	0.51	42.4	44.6	0.25
Mental component summary	44.2	46.7	0.32	46.9	49.1	0.46

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TABLE IV: Effect of Workers' Compensation Status on Limb-Specific and General-Health-Status Scores

*SPADI = Shoulder Pain and Disability Index, and SF-36 = Short Form-36.†WCB = Workers' Compensation Board.

Outcome Measure*	Preoperative			Postoperative
Score (points)		P Value	Score (points)		P Value
No WCB Claim† (N = 48)	WCB Claim †(N = 23)	No WCB Claim †(N = 45)	WCB Claim †(N = 22)
SPADI	36.4	29.7	0.02	80.8	61.7	0.01
SF-36
Physical component summary	38.9	32.9	0.02	45.8	38.7	0.005
Mental component summary	47.6	41.4	0.01	50.7	42.4	0.01

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TABLE IV: Effect of Workers' Compensation Status on Limb-Specific and General-Health-Status Scores

*SPADI = Shoulder Pain and Disability Index, and SF-36 = Short Form-36.†WCB = Workers' Compensation Board.

Outcome Measure*	Preoperative			Postoperative
Score (points)		P Value	Score (points)		P Value
No WCB Claim† (N = 48)	WCB Claim †(N = 23)	No WCB Claim †(N = 45)	WCB Claim †(N = 22)
SPADI	36.4	29.7	0.02	80.8	61.7	0.01
SF-36
Physical component summary	38.9	32.9	0.02	45.8	38.7	0.005
Mental component summary	47.6	41.4	0.01	50.7	42.4	0.01