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. 2019 Dec 9;2019(12):CD013502. doi: 10.1002/14651858.CD013502

NCT02059473.

Trial name or title Treatment of small acute full‐thickness tears ‐ a prospective randomised controlled trial
Methods Randomized Controlled Trial
Participants Estimated enrolment: 50
Inclusion Criteria
  • Trauma to the shoulder

  • Full thickness cranial rotator cuff tear

  • Operation possible within 3 months


Exclusion Criteria
  • 2 or more rotator cuff tendons involved

  • Fracture

  • Dislocation

  • Previous shoulder condition (symptomatic osteoarthritis (Gleno‐humeral (GH) joint, Acromial‐Clavicular (AC) joint), frozen shoulder, instability, tumour)

  • Malignancy

  • Rheumatic disease

  • Inability to understand Swedish

  • Substance abuse

Interventions Arm 1: physiotherapy and surgery (mini‐open rotator cuff repair)
Arm 2: physiotherapy
Outcomes Primary Outcome
Constant score at 12 months
 Secondary Outcome
Western Ontario Rotator Cuff score
Shoulder specific, patient reported outcome score
 MRI (measure of muscle atrophy, fatty infiltration, re‐rupture and enlargement of the tendon rupture)
 Euro‐Qol‐five‐Dimensions (EQ‐5D)
 Patient Global Impression of Change (PGIC)
Patients Global impression of Change
Starting date November 2013
Contact information Hanna Hallgren, MD +46 10 1037205 hanna.bjornsson.hallgren@lio.se
Mats Ranebo, MD +46 480 81432 matsra@ltkalmar.se
Notes Estimated study completion date: November 2017; Estimated primary completion date (final data collection date for primary outcome measure): December 2015
Recruitment Status : Unknown 18th June, 2018