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

NACompletedINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

December 31, 2016

Primary Completion Date

January 31, 2025

Study Completion Date

January 31, 2025

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.

Trial Locations (17)

Unknown

Helsinki University Hospital, Helsinki

Central Finland Central Hospital, Jyväskylä

Kuopio University Hospital, Kuopio

Oulu University Hospital, Oulu

Satakunta Central Hospital, Pori

Hatanpää Hospital, Tampere

Tampere University Hospital, Tampere

Turku University Hospital, Turku

Vaasa Central Hospital, Vaasa

Sørlandet sykehus HF, Arendal

Oslo University Hospital, Ullevål Hospital, Oslo

Martina Hansens Hospital, Sandvika

St. Olafs Hospital HF, Trondheim

Skånevård Sund, Region Skåne, Helsingborg

Kalmar County Hospital, Kalmar

Linköping University Hospital, Linköping

Varberg Hospital, Varberg

All Listed Sponsors
lead

Turku University Hospital

OTHER_GOV

NCT02885714 - ACCURATE Trial - Operative Treatment of Acute Rotator Cuff Tear Related to Trauma | Biotech Hunter | Biotech Hunter