NCT01000935.
| Trial name or title | Impact of autologous platelet rich plasma on enhancing repair of rotator cuff tendons: a multicentre randomised controlled trial |
| Methods | Study design: randomised controlled trial Random sequence generation: not reported Allocation concealment: not reported Masking: double blind (subject, outcome assessor) |
| Participants | Location: Target sample size (N): Inclusion criteria: age >18 years; diagnosis of partial or full thickness rotator cuff tear of ≤ 3 cm; confirmed by MRI or US within a period of 6 months prior to booking surgery; the final inclusion will be based on arthroscopic assessment of the tear size and lack of significant concurrent pathology Exclusion criteria: unable to speak or read English; nonrepairable tear; acute tears (< 6 month); evidence of major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory arthropathy, frozen shoulder; concurrent pathology of SLAP lesions, Bankart lesions, or advanced osteoarthritis of the glenohumeral joint; previous surgery of the affected shoulder; bone marrow pathology; abnormal platelet count; serum haemoglobin concentration < 11 g/dL or hematocrit < 34%; use of systemic cortisone; current use of anticoagulants (i.e. aspirin); use of an investigational drug and/or blood donation within 3 months prior to surgery; substance or alcohol abuse; heavy smoking (> 20 cigarettes/day, based on definition of the World Health Organization (WHO)); psychiatric illness that precludes informed consent |
| Interventions |
PRP: PRP will be applied to the surgical site after completion of the repair (methods not reported) Standard‐of‐care: arthroscopic repair |
| Outcomes | Primary outcomes: visual analogue pain scale Secondary outcomes: adverse effects; MRI; patient‐focused outcomes: short WORC; ASES form; the CM score Timing of outcomes measurement: pain diary (1‐30 days), 6 weeks, 3 months, 6 months |
| Starting date |
Main ID: NCT01000935
Date of registration: September 2009 Last refreshed on: August 2013 Date of first enrolment: March 2011 Status: recruiting |
| Contact information | Name: Richard Holtby, MD Address: Sunnybrook Health Sciences Centre Telephone: not reported Email: helen.razmjou@sunnybrook.ca, gail.gunnis@sunnybrook.ca Affiliation: Sunnybrook Health Sciences Centre |
| Notes |