NCT02885714.

Trial name or title	ACCURATE (Operative treatment of acute rotator cuff tear related to trauma)
Methods	Design: multi‐centre, parallel group, two‐arm (1:1) double‐blind randomised placebo‐controlled trial
Participants	Planned sample size = 200 Inclusion Criteria Age of patient over 45 and below 70 years Acute onset of shoulder symptoms after a traumatic event (any kind of sudden stretch, pull, fall, or impact, on the shoulder that is associated with the onset of symptoms) Shoulder symptoms relating to rotator cuff tear = pain laterally on the shoulder and/or painful motion arc during abduction or flexion MRI documented full thickness supraspinatus tear Exclusion Criteria Traumatic event of the shoulder due a criminal act of violence with legal consequences A delay of more than 4 months after the onset of symptoms of trauma to the day of intervention Arthroscopically documented partial thickness rotator cuff tear only A large MRI documented full thickness rotator cuff tear, sagittal tear size at the level of footprint larger than 3cm MRI or arthroscopically documented total width of infraspinatus or subscapularis tear MRI or arthroscopically documented fully dislocated biceps tendon (biceps out of the groove) with concomitant subscapularis tear Positive clinical rotatory lag sign (ER1 lag (>10 degrees), lift off lag (involuntary drop against the back), horn blower lag (involuntary internal rotation of the forearm in supported elevated position)) Marked fatty degeneration in any of the cuff muscles (more than Fuchs/Goutallier grade 2) Radiographically or MRI documented concomitant fracture line of the involved extremity or bony avulsion of the torn tendon or dislocation of the humeral head or the acromioclavicular joint. Concomitant clinically detectable motoric nerve injury affecting the shoulder Radiographically documented severe osteoarthritis of the glenohumeral joint, Samilson‐Prieto 2 or above Non‐congruency of the glenohumeral joint in radiographs (Hamada stage 2 or above) Clinical stiffness of the glenohumeral joint (severely limited passive range of motion: glenohumeral external rotation < 30 degrees, and abduction with stabilized scapula < 60 degrees) Previous surgery of the affected shoulder (affecting clavicle, scapula or upper third of the humerus) Earlier sonographic or MRI finding of a rotator cuff tear Previous symptoms of the ipsilateral shoulder requiring conservative treatment (glucocorticosteroid injections and/or physiotherapy) delivered by health care professionals during the last five years Systemic glucocorticosteroid or antimetabolite medication during the last 5 years Ongoing treatment for malignancy ASA classification 3 or 4 Patient's inability to understand written and spoken Finnish, Norwegian or Swedish History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardise informed consent Patients with a contraindication/noncompliance for MRI examination or use of electrocautery devices Previous randomisation of the contralateral shoulder into the ACCURATE trial Patient's denial for operative treatment and/or participation in the trial
Interventions	Group 1 (Placebo surgery and supervised specific exercises) The arthroscope is introduced in the glenohumeral joint, and thereafter online randomisation 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. Group 2 (Rotator cuff repair and supervised specific exercises) The arthroscope is introduced in the glenohumeral joint, and thereafter online randomisation 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.
Outcomes	Primary outcome Change in Western Ontario Rotator Cuff index (WORC) compared to baseline at two years. Secondary outcomes Constant Score Shoulder specific outcome measure combining subjective and objective variables Numeric rating scale of patients' shoulder pain during the last week at rest, during activity and at night (NRS) Scale 0 to 10. 0 = no pain and 10 = worst possible pain. 15D Generic health‐related quality of life instrument Subjective patient satisfaction Patient reported scale for treatment satisfaction Rotator cuff integrity in MRI investigation Development of osteoarthritic signs in radiographs Development of cuff tear arthropathy in radiographs
Starting date	December 2016
Contact information	Contact: Ville Äärimaa, Adj.Prof.+35823130000 ville.aarimaa@tyks.fi
Notes	Updated 18th June 2018 from Clinicaltrials registry. Recruitment Status : Recruiting Last refreshed 17th October 2017