Shin 2012.

Methods	Design: a single‐centre randomised controlled trial Setting: hospital in South Korea Timing: participants were recruited from March 2006 through April 2008 Interventions: rotator cuff repair and acromioplasty versus rotator cuff repair alone. Sample size: power analysis indicated that a total sample size of 120 patients (60 patients in each cohort) would provide 80% power (alfa 0.05) to detect significant differences in ASES scores, assuming an effect size of 0.5 (mean difference of five points and standard deviation of 10 points). The sample size was also estimated by use of an equation appropriate for comparing 2 independent group proportions and was based on a 2‐sided level of .05 having 80% statistical power to detect a 30% difference in University of California, Los Angeles shoulder score. Analysis: no flow chart and authors do not report any deviations from the allocated treatment. Thus, it appears that authors report data for ITT analysis.
Participants	Number of participants: number of screened or excluded not reported. 150 randomised (75 to both groups) Data available for 60 (80%) in both groups at mean follow‐up, 35 months (range 24 to 54 months) Inclusion criteria: Small‐ to medium‐sized rotator cuff tear (< 3 cm) Exclusion criteria: Large‐ to massive‐sized tears (> 3 cm) Partial‐thickness tears Tears of the subscapularis that required repair Acromial osteophytes or spurs Concomitant pathology (SLAP or Bankart‐lesion) Revision surgery Baseline data: Rotator cuff repair with acromioplasty Mean (SD) age, years 57.8 (9.3) Number of females (%) 27 (45) Number (%) of dominant arm involved 42 (70) Mean (SD) duration of symptoms 13.9 (20.6) Number (%) of traumatic onset 21 (35) Shape of acromion flat 18 (30); curved 32 (53); hooked 10 (17) Mean (SD) thickness of acromion, mm 7.75 (1.26) Mean size (SD) of tear (anteroposterior) 14.6 (5.2) Mean size (SD) of tear (retraction) 14.0 (5.3) Mean (SD) Goutallier class 1.5 (0.6) Number (%) of concomitant subscapularis tear 21 (35) Number (%) of concomitant cartilage injury 4 (7) Number (%) of concomitant biceps procedures 12 (20) Mean (SD) pain on VAS 5.5 (2.4) Mean (SD) ASES 52.6 (18.5) Mean (SD) Constant score 58.3 (15.8) Mean (SD) UCLA score 18.9 (4.5) Rotator cuff repair without acromioplasty Mean (SD) age, years 55 (8.0) Number of females (%) 26 (43%) Number (%) of dominant arm involved 45 (75) Mean (SD) duration of symptoms 16.7 (22.7) Number (%) of traumatic onset 24 (40%) Shape of acromion flat 15 (25); curved 36 (60); hooked 9 (15) Mean (SD) thickness of acromion, mm 6.9 (1.98) Mean size (SD) of tear (anteroposterior) 15.3 (7.0) Mean size (SD) of tear (retraction) 14.2 (6.0) Mean (SD) Goutallier class 1.4 (0.6) Number (%) of concomitant subscapularis tear 23 (38) Number (%) of concomitant cartilage injury 6 (10) Number (%) of concomitant biceps procedures 17 (28) Mean (SD) pain on VAS 5.5 (2.4) Mean (SD) ASES 51.5 (16.9) Mean (SD) Constant score 56.8 (17.6) Mean (SD) UCLA score 19.7 (5.8)
Interventions	Rotator cuff repair with acromioplasty After bursectomy, the surgeon performed subacromial decompression (acromioplasty and release of the coracoacromial ligament). Acromioplasty was confined to the anterolateral aspect of the acromion by use of the cutting‐block technique. The Coracoacromial ligament was completely released. With the arthroscope coming from the lateral portal the shaver was introduced from the posterior portal. The posterior aspect of the acromial undersurface served as a cutting block to guide the resection of the anterolateral edge of the acromion from posterior to anterior. Then, the shaver was switched to the lateral portal while the arthroscope was introduced from the posterior portal. The acromion was made flat from the medial to the lateral aspect of the acromion. Arthroscopic rotator cuff repair was performed by either a single‐row or double‐row technique according to the tear size and configuration. The single‐row repair technique was usually used for small‐sized rotator cuff tears and the double‐row technique for medium sized rotator cuff tears. When a partial‐thickness tear of the subscapularis was found, it was treated with arthroscopic debridement. Biceps tendon procedures were determined at the time of surgery depending on the patient’s age and the degeneration of the tendon. Biceps debridement alone was performed if the tendon tear was less than 50% of the thickness of the tendon or was partially frayed. Biceps tenodesis with a suture anchor was performed when the tendon tear involved more than 50% of the tendon thickness and the patient was aged less than 60 years. If patients were aged older than 60 years and the tendon tear involved more than 50% of the tendon thickness, biceps tenotomy was performed. Rotator cuff repair without acromioplasty Coracoacromial ligament was debrided without release. The authors do not explicitly report the extent of bursectomy in this group; it is likely that bursectomy was performed to facilitate visibility during repair. The repair was performed following same principles as in acromioplasty group. Both groups The same postoperative rehabilitation protocol was applied in all participants. A shoulder brace with 0° of external rotation and 30° of abduction was applied in all patients for four weeks (small‐sized tear) or five weeks (medium‐sized tear) postoperatively. Pendulum exercises and gentle passive shoulder range‐of‐motion exercises commenced three days after surgery. Active assisted shoulder range‐of‐motion exercises began after weaning from the brace, and resisted shoulder motion and strengthening exercises began at three months.
Outcomes	According to the methods section, the authors assessed outcomes 1, 3, 6, 12, and 24 months postoperatively and then annually (longest follow‐up at mean of 35 months, range 24 to 54 months) Primary outcome ASES score (American Shoulder and Elbow Surgeons score, 0 to 100, higher score indicates better function, used for sample size calculation) Secondary outcome UCLA score (0 to 35, higher score indicates better function) Constant score (0 to 100, higher score indicates better function) VAS for pain (0 to 10, higher indicates worse pain) VAS for satisfaction (0 to 10, higher score indicates likely – not explicitly reported – better satisfaction) Shoulder range of motion (degrees) Failure rate; number or proportion participants with re‐tear or non‐healing of repair (defined by MRI, CT or ultrasound) Postoperative shoulder stiffness Outcomes used in this review Mean pain; Pain in VAS Mean function; Constant score Adverse events Failure rate (participants with full‐thickness tear at six months diagnosed with MRI, 76 participants or CT, 42 participants or ultrasound, 2 participants)
Source of funding	Source of funding not reported. The authors report no conflicts of interest
Notes	Trial registration: N/A Data analysis: Withdrawals: 15/60 (25%) of participants dropped out or declined follow‐up in both groups. Re‐operations: in repair with subacromial decompression group, arthroscopic capsular release was performed in two patients who exhibited a contracted capsule due to inflammatory processes and arthroscopic bursectomy was performed in one patient who had decreased range of motion even after two months of intensive physical therapy. Adverse events: incompletely reported (Quote: "Postoperative complications including limitation of shoulder motion due to rotator cuff adhesion occurred in patients regardless of completion of an acromioplasty"). Serious adverse events: likely there were none as the authors reported. Not explicitly reported.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	quote: "Each patient was randomised into one of two groups." Not reported how the sequence was achieved
Allocation concealment (selection bias)	Unclear risk	Allocation concealment not described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not described
Blinding of outcome assessment for self‐reported outcomes including pain, function and global assessment (detection bias)	Unclear risk	Not described, participants likely not blinded
Blinding of outcome assessment for incidence of full‐thickness tears at follow‐up (detection bias)	High risk	Not described, it is probably not possible to blind the radiologists reliably from allocation as the repair was performed using metal anchors.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Similar rates (15/75 or 20%) lost in follow‐up due to drop out or declined to participate in follow‐up. The reasons not given. Unclear if the reasons were different.
Selective reporting (reporting bias)	Low risk	The authors reported collecting data at 1, at 3, 6, 12 and a mean of 35 months. One‐month data not reported although stated that they were collected. Patient satisfaction reported only at one time point. As one‐month data have little clinical significance, we assessed the risk of bias as low.
Other bias	Low risk	The extent of bursectomy in repair‐only group not described explicitly. It is likely that authors performed bursectomy and the only difference between the groups was removal of bone from undersurface of acromion and this is unlikely to cause bias.

ASES: American Shoulder and Elbow Surgeons Score; CT: Computed Tomography; DASH: Disabilities for Arm, Shoulder and Hand; HRQoL: Health‐related quality of life; ITT: intention‐to‐treat; MID: Minimal Important Difference; MRI: Magnetic Resonance Image; SD: standard deviation; SF: Short Form; SST: Simple Shoulder Test; UCLA: University of California and Los Angeles; VAS: visual analogue scale;WORC: Western Ontario Rotator Cuff.