Saurabh Odak, Eric Powell, David Temperley, John F. Haines & Ian Trail Department of Shoulder Surgery, Wrightington Hospital, Wigan, UK

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1 Shoulder & Elbow. ISSN S ORIGINAL ARTICLE A randomized controlled trial to assess the efficacy of arthroscopic subacromial decompression with and without rotator cuff repair using a mini-open technique Saurabh Odak, Eric Powell, David Temperley, John F. Haines & Ian Trail Department of Shoulder Surgery, Wrightington Hospital, Wigan, UK Received Received 7 July 2011; accepted 20 December 2011 Keywords Arthroscopic subacromial decompression, subacromial impingement, rotator cuff tear, rotator cuff repair Conflicts of Interest None declared Correspondence Saurabh Odak, Department of Shoulder Surgery, Wrightington Hospital, Wigan, UK. Tel.: Fax: saurabhsodak@gmail.com DOI: /j x ABSTRACT Background Management of degenerate rotator cuff tears associated with subacromial impingement is debatable. Methods We performed a prospective, randomised controlled trial to assess the efficacy of arthroscopic subacromial decompression (ASD) with or without repair of the rotator cuff using a mini-open technique. Results 42 patients (29 males and 13 females) with a mean age of 64 years (range years) were recruited. 25 patients underwent ASD and cuff repair using mini-open technique whereas 17 patients had only ASD alone. All the patients were followed for a minimal of 1 year post-operatively. At final follow-up the mean Constant scores and patient satisfaction scores were not different between the groups (p value 0.06 and 0.44 respectively). The mean DASH scores were marginally significant (p value 0.05) and mean ASES scores were significant (p value 0.03). A 38% cuff rerupture rate was noted in the cuff repair group. Conclusions Our study demonstrates that in short-term the results of ASD with or without rotator cuff repair are not significantly different, however positive trends were noted in the cuff repair group. Although a significant rerupture rate was noted (38%) this had little effect on the outcome. INTRODUCTION The prevalence of degenerative rotator cuff tears progressively increases with age and is one of the common condition affecting the shoulders [1 14]. In 1972, Neer postulated the mechanical or extrinsic theory of subacromial impingement and associated rotator cuff tears and described open anterior acromioplasty with excision of the coracoclavicular ligament as a treatment, which has remained the standard for many decades [12]. Arthroscopic acromioplasty, commonly called arthroscopic subacromial decompression (ASD), is now more commonly performed with results comparable to open acromioplasty [1,15,16]. However, the management of associated degenerate rotator cuff tears is still a matter of debate. Studies assessing the long-term outcome in patients with surgically repaired rotator cuff tears have shown good to excellent results in terms of pain relief and function. However, they have also reported a high re-rupture rate, ranging up to 60% [17 19]. Similar favourable results have also been achieved with ASD performed alone without repairing the rotator cuff; hence, uncertainty persists regarding the role of the surgical repair of rotator cuff tears in these patients [20 22]. We performed a randomized controlled trial to compare the efficacy of ASD alone and ASD along with repair of the rotator cuff using a mini-open technique. The present study aimed to prospectively evaluate and compare objective and subjective outcomes in patients undergoing ASD with or without repair of the rotator cuff. MATERIALS AND METHODS Ethical approval was obtained before commencement of the study. Patients with a painful shoulder with a suspicion of primary subacromial impingement (SAI) and associated rotator cuff tear were deemed suitable for the trial. Patients with traumatic tears, massive or irreparable tears and with features of cuff tear arthropathy were excluded. All patients were assessed by a consultant specializing in shoulder surgery. The diagnosis of SAI and associated rotator cuff tears was first confirmed clinically based on history and further corroborated by clinical examination. All patients underwent a diagnostic injection of a mixture of local anaesthetic(chirocaine; Abbot Laboratories, Maidenhead, UK; 5 mg/ml) and a long acting steroid (Depo-medrone; Pharmacia & Upjohn, Bridgewater, NJ, USA; 40 mg/ml) into the subacromial space. A temporary relief of symptoms was considered to be a positive sign for SAI. Radiologically, all patients had an anteroposterior, axillary and an outlet view. Further investigations in the form of ultrasound or magnetic resonance imaging scans were performed in patients with equivocal clinical signs and to confirm the diagnosis. Once diagnosed, all patients were initially treated conservatively with analgesia and physiotherapy. Surgery was offered only when the conservative measures had failed, at which time they were offered to participate in the trial. Patients were included on the day of their surgery and written informed consent was obtained on the day of surgery. 112 Shoulder and Elbow. Shoulder and Elbow , pp

2 Initially, a diagnostic shoulder arthroscopy was performed to furtherconfirmthediagnosis, toassessthesizeofthecufftearandto rule out any exclusion criterion, where-upon block-randomization was performed via a presealed envelope. The patients were assigned to one of the two limbs of the trial, namely ASD without repair and ASD with repair of the cuff. Operative technique Surgery was performed under a general anaesthetic with an interscalene nerve block in all patients. All patients underwent an examination under anaesthesia before the procedure. Shoulder arthroscopy was undertaken in either the lateral decubitus or beach chair position depending on the choice of the surgeon and ASD was performed using standard arthroscopy portals. The size of the cuff tear was now assessed intra-operatively. Full thickness rotator cuff tears were sub-divided into small (<1 cm), medium (1 cm to 3 cm), large (3 cm to 5 cm) and massive (>5 cm). A 4.5-mm scope with fluid management system was utilized using tissue resectors and burrs. The under surface of the acromion was flattened and the coraco-acromial ligament released in all cases as a predetermined standardized operative technique in both groups. If clinically indicated, the lateral 1 cm of the clavicle was also excised. In patients undergoing cuff repair, the area was re-prepped and draped. Thereafter, using a mini-open technique employing a deltoid split, the cuff tear was identified and reinserted back into the greater tuberosity. The insertion of the cuff was freshened with a bony burr and the edge of the retracted cuff was trimmed. The repair was undertaken using two or three Twin Fix (Smith and Nephew, London, UK) 5.5-mm bone anchors. Satisfactory repair was obtained in all cases. The deltoid was then re-attached with 2-0 vicryl followed by a skin closure. A drain was left in situ for 24 hours. Postoperative rehabilitation regimen In patients with cuff repair, the shoulder was immobilized in a shoulder-sling postoperatively for a period of 3 weeks to 4 weeks. During this period, patients were allowed to carry out passive range of motion and shoulder girdle exercises to maintain movements. This was followed by gentle isometric and graduated active glenohumeral exercises over the next 2 weeks to 3 weeks. The shoulder sling was weaned off at this time. The last phase of rehabilitation consisted of full range of motion active exercises along with cuff strengthening, closed chain and proprioceptive exercises. Patients in the ASD alone group were also discharged with a shoulder sling; however, it was removed in 2 days to 3 days. This was followed by active-assisted shoulder movements in all the planes. Once the pain settled, patients were commenced on isometric cuff strengthening exercises. Evaluation All patients were assessed pre-operatively, and also at 3 months, 6 months and a minimum of 12 months postoperatively, by an independent observer who was blind to the nature of the surgical intervention. At each visit, patients were assessed using Constant Murley shoulder outcome score, Disabilities of the Arm, Shoulder and Hand (DASH) outcome score and American Shoulder and Elbow Surgeons (ASES) subjective scale scores. A subjective assessment of patient satisfaction was also carried out on an arbitrary scale of 0 to 100, where 0 = not satisfied and 100= highly satisfied. Similarly, any complications that occurred during or after the surgery, along with patients who underwent further surgeries, were also noted. All the measurements and assessments were performed by an independent observer. All patients were later invited to have an ultrasound scan of the operated shoulder as part of the study protocol. Statistical analysis The homogeneity of the variables was determined by using Kolmogorov Smirnov test. For uniformly distributed variables, an independent sample t-test was applied and, for non-uniformly distributed variables, a Mann Whitney U-test was applied. Fisher s exact test was used to assess significance between the groups. p 0.05 was considered statistically significant. SPSS, version 16 (SPSS Inc., Chicago, IL, USA) was used for all statistical analyses. RESULTS Patient demographics A total of 42 patients (29 males and 13 females) were included in the trial. The mean (SD) age at the time of presentation was 64 (5.6) years (range 54 years to 77 years). The presence of a rotator cuff tear was determined clinically in 22 patients and further investigations were required in 20 patients (ultrasound scan in 14 and magnetic resonance imaging scans in six patients). The mean duration of preceding symptoms was 11 months (range 7 months to 36 months). Twenty-nine patients (16 ASD with cuff repair and 13 ASD alone ) had the surgery on their dominant arm. Twenty-five patients were randomized to arthroscopic ASD with cuff repair and 17 patients to the ASD alone limb of the trial. Both groups were comparable in terms of age, gender and duration and severity of preceding symptoms (Table 1). The average size of the tear was 18 mm and there was no significant difference between the groups. Table 2 summarizes the state of the rest of the muscles, Table 1 Patient demographics of the study groups Repaired Nonrepaired Mean age (years) Range (years) 54 to to 77 Sex Males Females 7 6 Duration of symptoms (months) Mean (SD) (4.8) (5.1) Size of cuff tear (mm) Mean (SD) (4.0) (3.8) Shoulder and Elbow. Shoulder and Elbow , pp

3 Table 2 Table comparing the state of rest of the rotator cuff and biceps tendon between the groups Table 4 Mean American Shoulder and Elbow Surgeons (ASES) scores Not repaired Repaired Total Subscapularis Normal Frayed Partial tear Full tear Infraspinatus Normal Frayed Partial tear Full tear Long head of biceps appearance Normal Frayed Absent Division of long head of biceps No Yes Lateral clavicle excision Not excised Excised Table 3 Constant Murley scores Pain pre-operatively Pain at final follow-up ADL pre-operatively ADL at final follow-up Motion pre-operativly Motion at final follow-up Power pre-operatively Power at final follow-up Total Constant score pre-operatively Total Constant score at final follow-up Not repaired Repaired p 3.8 (4.2) 9.1 (5.5) 9.9 (4.7) 13.6 (3.9) 20.1 (7.0) 32.1 (6.9) 6.8 (4.0) 8.7 (6.9) 40.7 (12.7) 65.3 (17.6) Data are the mean (SD). ADL, Activities of daily living. 5.4 (3.5) 12.9 (3.3) 8.2 (2.5) 16.0 (4.8) 21.4 (7.7) 34.0 (6.9) 5.9 (3.8) 12.8 (6.9) 41.0 (13.6) 76.4 (18.2) the long head of biceps and the acromioclavicular joint in both groups of patients. Constant scores Table 3 summarizes the overall Constant scores and the individual components in the repaired and nonrepaired groups. As noted, there was a positive trend noted in the overall Constant scores in the cuff repair group; however, this was not statistically significant (p = 0.06). Considering individual components, there was only a significant improvement in pain compared to the pre-operative levels at the final follow-up in the repaired group. The rest of the components only reflected a positive trend but did not improve significantly. ASES score component Cuff repaired Cuff not repaired p Pain score- pre-operative 23.7 (14) 18.9 (10.5) 0.20 Pain score- final 43.4 (8.1) 36.6 (14.2) 0.06 follow-up ADL: pre-operative 19.6 (9.0) 17.7 (8.7) 0.05 ADL: final follow-up 41.9 (11.7) 35.5 (12.1) 0.03 Overall ASES score: 43.1 (19.9) (14.5) 0.21 pre-operative Overall ASES score: final follow-up 85.9 (14.7) 70.2 (24.9) 0.03 Data are the mean (SD). ADL, Activities of daily living. Table 5 Mean Disabilities of the Arm, Shoulder and Hand (DASH) scores DASH score Cuff repaired Cuff not repaired p Pre-operative 48.3 (13.5) 57.1 (16.1) 0.06 At final follow-up 18.7 (19.2) 33.1 (23.1) 0.05 Data are the mean (SD). Independent sample t-test. Mann WhitneyU-test. ASES scores There was a marginally significant improvement in mean overall ASES scores in the cuff repair group compared to nonrepair group at final follow-up (Table 4). In terms of individual components, patients in the cuff repair group scored significantly better in the Activities of daily living part of the ASES score, namely putting on a coat, sleeping on the affected side, washing, cleaning and toileting, combing hair, lifting a weight of 10 lbs above shoulder height, throwing a ball overhead, doing usual activities, doing usual sports. Unexpectedly, a positive trend was noted in pain relief, although it was not found to be significant as opposed to that for the Constant score. DASH scores The mean DASH score was statistically significant at final follow-up in the cuff repair group (Table 5). Overall improvement Table 6 summarizes and compares the overall improvement in the scores across both the groups. As noted, there was improvement noted in all the scores in both groups of patients compared to the pre-operative level; however, when the difference was compared between the groups, only the Activities of daily living component of the Constant score was found to be statistically significant. Patient satisfaction Mean (SD) patient satisfaction scores at final follow-up were (31.15) (n = 16) and (10.69) (n = 24) in the cuff repair and 114 Shoulder and Elbow. Shoulder and Elbow , pp

4 Table 6 Table summarises and compares the overall improvement in the scores across both the groups Modality Difference of mean final score and the pre-operative score Cuff repaired group Cuff nonrepaired group Overall ASES score Overall Constant score DASH score ASES, American Shoulder and Elbow Surgeons; DASH, Disabilities of the Arm, Shoulder and Hand. ASD alone groups, respectively. However, again, there was no statistically significant difference between the groups (p = 0.44). Postoperative ultrasound scan Intotal,33 patients(21withcuffrepairedand12withoutrepair)had a postoperative ultrasound scan to assess the state and integrity of the cuff at a mean duration of 44 months (range 7 months to 84 months). Of the 21 patients in the cuff repair group, eight patients showed a re-rupture (38%) whereas, in 13 patients, the cuff was intact (62%), and four patients did not attend the scan for various reasons. No significant difference was noted in mean pain, Constant, ASES and DASH scores in patients with a re-rupture and in patients with intact cuff in this group of patients. In the patients who underwent a cuff repair and showed a re-rupture on repeat scans, there was no significant difference in the size of the tear before and after the surgery (p = 0.79). In the nonrepaired group, the postoperative scans did not reveal any significant progression in the size of cuff tear compared to the pre-operative size (p = 0.55). Revision and complications Three out of 25 patients (12%) in the cuff repair group required a secondary procedure for persistent or recurrent symptoms at a mean of 39 months (range 15 months to 53 months) after the index procedure. One patient had a revision ASD followed by open repair of the rotator cuff. The other two patients had revision ASD and excision of acromioclavicular joint (ACJ). Three out of 17 patients (18%) in the ASD alone group also required a secondary procedure at a mean of 17 months (range 7 months to 28 months). Two patients had a mini-open repair of the rotator cuff and one patient had a revision ASD with ACJ excision. Overall, however, there is no statistically significant difference in revision rate (p = 0.67, odds ratio = 1.5, confidence interval = 0.27 to 8.49). No further complications were reported in either group. DISCUSSION Several factors have been implicated in the pathogenesis of chronic degenerate rotator cuff tears, including mechanical impingement, age-related degeneration, localized inflammation, hypoxia and reduced vascularity of the tendon [12,13,23,24]. Studies assessing p the natural progression of cuff tears suggest that the majority of the cuff tears are asymptomatic [25 28]. However, in some patients over time, they can become symptomatic, requiring treatment. The initial line of management is usually conservative in the form of pain control and physiotherapy. Surgery is only required once conservative measures fail. Although open acromioplasty or ASD has been the treatment of choice for subacromial impingement, there is considerable ambiguity in the current literature regarding the management of associated rotator cuff tears. On the one hand, there is a large body of evidence supporting the surgical repair of rotator cuff tears. Long-term studies have shown good outcome and improved shoulder function in patients who undergo cuff repair, despite a re-rupture rate of 20% to 70% [19,29]. Gartsman et al. in a randomized controlled trial reported no difference in pain relief and shoulder functions at a minimum of 1 year when comparing arthroscopic cuff repair to cuff repair with ASD [30]. They concluded that, for patients with a full-thickness cuff tear and a type 2 acromion, arthroscopic subacromial decompression had no statistically significant benefit over cuff repair. By contrast, several studies have reported good long-term results in terms of pain relief, the ability to perform activities of daily living and objective shoulder scores in patients treated with ASD alone without repair of the rotator cuff [20 22]. Studies have reported that ASD alone can prevent further progression of partial thickness and small full thickness cuff tears and hence the repair of these tears might not be necessary in the long-term [20]. Most of these published studies, however, are limited by a lack of randomization and control groups, high attrition rates and reporting bias. To our knowledge, the present study is the first prospective randomized controlled trial comparing ASD with or without repair of rotator cuff. We used comprehensive outcome measures to ensure a comparison with any previously reported findings in literature. Another strength of the present study is near complete clinical and radiological (84%) follow-up. The present study has shown an overall positive trend towards cuff repair compared to ASD alone at a minimum of 1-year followup. However, statistically significant differences were only found in mean ASES scores (p = 0.03) and DASH scores (p = 0.05). No such significant differences were noted in overall Constant scores and patient satisfaction scores. The proportion of patients requiring a revision procedure in cuff repair group was slightly less than that in the ASD alone group (12% versus 18%); however, this difference again was not significant (p = 0.67). We did notice that patients in the ASD alone group required the revision procedure earlier than those in the cuff repair group (17 months versus 39 months). In addition, 38% of the patients in the cuff repair group revealed a re-rupture of the cuff on the follow-up ultrasound scan and 62% showed an intact cuff. However, there was no difference in various outcome measures between these two subgroups. Similarly, in the nonrepaired group, no significant progression of the size of tear was noted. The limitations of the present study include a relatively short follow-up period and a smaller sample size. Although preliminary results do show a positive trend, firm conclusions cannot be drawn and hence a longer-term follow-up of these patients is planned. The Shoulder and Elbow. Shoulder and Elbow , pp

5 overall recovery of patients may depend on several other factors apart from repair of cuff or subacromial decompression (e.g. physiological age of the patient, acromioclavicular joint pathology, status of the long head of biceps and other cuff muscles). The small sample size precluded stratified randomization to account for these confounders. However, because this maintains the generalizability of the results, the above study design was deemed acceptable. Similarly, because the cuff repair was performed using a mini-open technique, blinding in the study was not possible. However, we can safely assume that it cannot affect various objective outcome measures used in the present study. Conclusions The present study demonstrates that, in the short term (1 year postoperatively), the results of ASD with or without cuff repair are not significantly different; however, positive trends were noted in the cuff repair group. 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