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Rotator cuff tear is a very common and disabling condition that can be related to acute trauma such as falling on the shoulder. A tear is associated with symptoms such as pain in abduction, abduction weakness and night pain. Rotator cuff tear surgery is a well-established form of treatment in acute rotator cuff tears, although beneficial results have been reported for both conservative and surgical treatment of rotator cuff tears. Rotator cuff tear repair surgery involves a considerable amount of re-ruptures, and it is possible that the repaired tendon do not heal despite surgical repair. On the other hand rotator cuff tears are also found in completely asymptomatic persons and the clinical significance of a rupture may be generally lower than estimated. The above-mentioned factors, as well as recent research and meta-analysis on the treatment of mainly degenerative rotator cuff tears indicate that there is a limited evidence that surgery is not more effective in treating symptomatic rotator cuff tear than conservative treatment alone. However, these previous research findings cannot be applied directly to traumatic tears, although degeneration can be considered always to contribute to the creation of a rotator cuff tear.
During few last decades, despite the lack of evidence on the superiority of one treatment over another, the use of surgery to treat this disorder has been substantially increased. Treatment expectations are found to be important in predicting patient related outcome measures. In addition, surgery itself may produce a profound placebo effect. There are no previous placebo-controlled trials on the topic of interest. In order to find out the true efficacy of surgical treatment of acute, trauma related rotator cuff tears involving mainly the supraspinatus tendon, the investigators have designed this multi-centre, randomized, placebo-controlled efficacy trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Placebo Comparator | Placebo surgery + supervised specific exercises |
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| Group II | Active Comparator | Rotator cuff repair + supervised specific exercises |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo surgery and supervised specific exercises | Procedure | The patient is prepared for surgery as normal (plexus+general anesthesia or TIVA, with antibiotic prophylaxis). The arthroscope is introduced in the glenohumeral joint, and thereafter online randomization is performed. The joint space is evaluated. Nothing is to be removed or excised and the use of any vapour or shaver device is not allowed. The presence of a full-thickness rotator cuff tear is verified. Altogether 3 to 5 small stab wounds are made in typical locations resembling locations of typical rotator cuff repair. The time spent in the operating theatre with patients in placebo group should resemble the time spent with patients in the active treatment group and hence give an impression of a rotator cuff repair. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Western Ontario Rotator Cuff index (WORC) compared to baseline at two years. | Patient reported disease specific outcome measure for rotator cuff conditions. | The change of WORC is also compared to baseline at 3 and 6 months, 1 , 2, 5 and 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Constant Score | Shoulder specific outcome measure combining subjective and objective variables | 3 and 6 months, 1 , 2, 5 and 10 years |
| Numeric rating scale of patients' shoulder pain during the last week at rest, during activity and at night. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juha Kukkonen, MD, PhD | Satakunta Central Hospital | Principal Investigator |
| Anssi Ryösä, MD | Turku University Hospital | Study Chair |
| Hanna Björnsson Hallgren, MD, PhD | University Hospital, Linkoeping | Study Chair |
| Stefan Moosmayer, MD, PhD | Martina Hansens Hospital | Study Chair |
| Teresa Holmgren, PT, PhD | University Hospital, Linkoeping | Study Chair |
| Mats Ranebo, MD | Kalmar County Hospital | Study Chair |
| Berte Bøe, MD, PhD | Oslo University Hospital | Study Chair |
| Ville Äärimaa, Adj.Prof. | Turku University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Helsinki | Finland | ||||
| Central Finland Central Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31110087 | Derived | Ryosa A, Kukkonen J, Bjornsson Hallgren HC, Moosmayer S, Holmgren T, Ranebo M, Boe B, Aarimaa V; ACCURATE study group. Acute Cuff Tear Repair Trial (ACCURATE): protocol for a multicentre, randomised, placebo-controlled trial on the efficacy of arthroscopic rotator cuff repair. BMJ Open. 2019 May 19;9(5):e025022. doi: 10.1136/bmjopen-2018-025022. |
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| Rotator cuff repair and supervised specific exercises | Procedure | The patient is prepared for surgery as normal (plexus+general anesthesia or TIVA, with antibiotic prophylaxis). The arthroscope is introduced in the glenohumeral joint, and thereafter online randomization is performed. The joint space is evaluated and the presence of a full-thickness rotator cuff tear is verified. The cuff tear is repaired to its anatomic location using suture anchors according to surgeon preference. . A biceps tenotomy or tenodesis may be performed according to surgeon preference if the biceps tendon is noted to be frayed, unstable or inflamed. An additional acromioplasty may be performed according to surgeon preference. |
|
Subjective pain intensity measure. The numeric pain rating scale (pain NRS). Scale 0 to 10. 0 = no pain and 10 = worst possible pain.
| 3 and 6 months, 1 , 2, 5 and 10 years |
| 15D | Generic health-related quality of life instrument | 3 and 6 months, 1 , 2, 5 and 10 years |
| Subjective patient satisfaction | Patient reported scale for treatment satisfaction | 3 and 6 months, 1 , 2, 5 and 10 years |
| Rotator cuff integrity in MRI investigation | 2, 5 and 10 years |
| Development of osteoarthritic signs in radiographs | 2, 5 and 10 years |
| Development of cuff tear arthropathy in radiographs | 2, 5 and 10 years |
| Jyväskylä |
| Finland |
| Kuopio University Hospital | Kuopio | Finland |
| Oulu University Hospital | Oulu | Finland |
| Satakunta Central Hospital | Pori | Finland |
| Hatanpää Hospital | Tampere | Finland |
| Tampere University Hospital | Tampere | Finland |
| Turku University Hospital | Turku | Finland |
| Vaasa Central Hospital | Vaasa | Finland |
| Sørlandet sykehus HF | Arendal | Norway |
| Oslo University Hospital, Ullevål Hospital | Oslo | Norway |
| Martina Hansens Hospital | Sandvika | Norway |
| St. Olafs Hospital HF | Trondheim | Norway |
| Skånevård Sund, Region Skåne | Helsingborg | Sweden |
| Kalmar County Hospital | Kalmar | Sweden |
| Linköping University Hospital | Linköping | Sweden |
| Varberg Hospital | Varberg | Sweden |