Sponsor study identifier
interventional
180
3 countries
17
Study Start
December 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2025
Actual (reported)Study Completion
January 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 19, 2016
Actual (reported)August 31, 2016
Actual (reported)December 2016
Date type not reportedThis date has not been verified as actual or estimated.
January 2025
Actual (reported)January 2025
Actual (reported)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
Constant Score
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.
3 and 6 months, 1 , 2, 5 and 10 years
15D
3 and 6 months, 1 , 2, 5 and 10 years
Subjective patient satisfaction
3 and 6 months, 1 , 2, 5 and 10 years
Rotator cuff integrity in MRI investigation
2, 5 and 10 years
Placebo surgery + supervised specific exercises
Rotator cuff repair + supervised specific exercises
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.
Helsinki University Hospital
Helsinki, Finland
Central Finland Central Hospital
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
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.
Juha Kukkonen, MD, PhD
Satakunta Central Hospital
Anssi Ryösä, MD
Turku University Hospital
Hanna Björnsson Hallgren, MD, PhD
University Hospital, Linkoeping
Stefan Moosmayer, MD, PhD
Martina Hansens Hospital
180 participants (actual enrollment reported by the registry).
First Submitted
August 19, 2016
First Posted
August 31, 2016
Study Start
December 2016
Date type not reportedThis date has not been verified as actual or estimated.
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.
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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
Teresa Holmgren, PT, PhD
University Hospital, Linkoeping
Mats Ranebo, MD
Kalmar County Hospital
Berte Bøe, MD, PhD
Oslo University Hospital
Ville Äärimaa, Adj.Prof.
Turku University Hospital
Primary Completion
January 2025
Actual (reported)Study Completion
January 2025
Actual (reported)Last Updated
May 1, 2025
Record last verified: 2025-04
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