Randelli 2011.
Methods | Randomised controlled trial: participants were randomised utilising block procedure. Participants had final follow‐up at 24 months Trial conducted: Department of Scienze Medico Chirurgiche, University of Milano, IRCCS Policlinico San Donato, Milano, Italy; recruitment: from April 2007‐January 2008 |
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Participants |
Participants: 53 undergoing arthroscopic repair of rotator cuff tears Inclusion criteria: a complete rotator cuff tear confirmed intraoperatively; agreed to wear a dedicated brace for 4 weeks postoperatively; had a preoperative platelet count > 150,000; minimum preoperative haemoglobin of 11.0 g/dL; no infectious diseases or diseases that may have limited follow‐up; BMI < 33 Exclusion criteria: previous rotator cuff repair; active infection; osteomyelitis or sepsis, or distant infections; osteomalacia or other metabolic bone disorders; unco‐operative or had disorders that made them incapable of following directions, or who were unwilling to return for follow‐up examinations; vascular insufficiency, muscular atrophy, or neuromuscular diseases of the affected arm; cigarette smokers; had received steroid injection(s) in the affected shoulder Age: PRT group mean (range): 61.6 years (8.3) No PRT mean (range): 59.5 years (10.7) Gender: PRT group (number of men:women): 8:19 No PRT (number of men:women): 13:13 Sports activity: not available |
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Interventions | Participants were submitted to arthroscopic rotator cuff repair (single row repair, absorbable anchors) by a single surgeon. Acromioplasty was performed in all cases PRT (number of participants = 26): single, intraoperative injection. 54 mL blood mixed with 6 mL citrate as an anticoagulant. The product was centrifuged for 15 minutes at 3200 rpm. PRP was separated and centrifuged (2 minutes) to increase fibrinogen concentration and mixed with PRP. A final 6 mL PRP was applied through the arthroscopic portals PRT preparation: kit: GPS II, Biomet Biologics (Warsaw, IN) Quantification of platelet concentrates after preparation: not reported No PRT (number of participants = 27): no platelet‐rich therapy controls Co‐interventions: same rehabilitation protocol |
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Outcomes | Constant score SST UCLA score VAS Strength in external rotation Rate of retear |
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Other quality issues |
Sample size: the authors calculated the sample size Validation of PRT: the exact composition of the PRP was unknown |
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Notes | Authors had 8 follow‐up losses (4 in each group). Pain was measured in short intervals in the early postoperative period | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation | Low risk | A block randomised procedure was used to generate a randomisation list |
Allocation concealment | Low risk | Used sequentially‐numbered, opaque and sealed envelopes |
Blinding All outcomes | Low risk | The participants and outcome assessors were blinded to the treatment |
Incomplete outcome data addressed All outcomes | Low risk | Missing outcome data were balanced in numbers across intervention groups |
Free of selective reporting | Unclear risk | The study protocol is not available but all expected outcomes were assessed |
Free of other bias | Low risk | The study appears to be free of other sources of bias |