ACCURATE Trial - Operative Treatment of Acute Rotator Cuff Tear Related to Trauma

Summary

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.

Conditions

• Acute Rotator Cuff Tear Related to Trauma

Interventions

PROCEDURE

Placebo surgery and 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.

PROCEDURE

Rotator cuff repair and 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 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.

Sponsors & Collaborators

• Turku University Hospital

  lead OTHER_GOV

Principal Investigators

• 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

• 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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-12-31

Primary Completion

2025-01-31

Completion

2025-01-31

Countries

• Finland
• Norway
• Sweden

Study Locations