Rodeo 2012.
Methods | Randomised controlled trial Trial conducted: Sports Medicine and Shoulder Service, The Hospital for Special Surgery, New York, New York, USA; recruitment: no details available Participants were followed for 24 months |
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Participants |
Participants: 80 undergoing arthroscopic repair of rotator cuff tears Inclusion criteria: participants ≥ 40 years of age for whom non operative treatment had failed Exclusion criteria: people undergoing revision, mini‐open, or open procedures; people with concomitant labral tears. Age: PRT group mean (range): 59.5 years (10.7) No PRT mean (range): 59.5 years (10.7) Gender: PRT group (number of men:women): 23:17 No PRT (number of men:women): 21:18 Sports activity: not available |
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Interventions | All participants underwent arthroscopic rotator cuff repair with bone anchors PRT (number of participants = 40): single intraoperative application, PRFM, 9 mL blood produced a PRFM product. Fibrin matrix was produced after a second centrifugation step, by the addition of CaCl2 PRT preparation: kit: Cascade Autologous Platelet System, Musculoskeletal Transplant Foundation, Edision, New Jersey, USA) Quantification of platelet concentrates after preparation: not stated No PRT (number of participants = 40): no platelet‐rich therapy controls Quantification of platelet concentrates after preparation: not reported Co‐interventions: same rehabilitation protocol |
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Outcomes | Ultrasound assessment (tendon healing) ASES Score L' Insalata score Shoulder strength |
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Other quality issues |
Sample size: author stopped trial as it had detected no benefit (target: 65 participants per group) Validation of PRT: the exact composition of the PRP was unknown |
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Notes | Participants lost to follow‐up: n = 5 (PRT), n = 7 (no PRT) The authors provided the study protocol/trial registration details, ID: NCT01029574 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation | Unclear risk | Not reported |
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 | High risk | Reasons for missing outcome data were not reported and there was imbalance in numbers across intervention groups |
Free of selective reporting | Low risk | The study protocol was available and all of the study’s pre‐specified (primary and secondary) outcomes that are of interest in the review were reported in the pre‐specified way |
Free of other bias | Low risk | The study appears to be free of other sources of bias |