Castricini 2011.
Methods | Randomised controlled trial: participants followed for at least 16 months. It is not clear if clinical assessors and participants were not blinded to the procedure. MRI assessors were blinded to the procedure Trial conducted: Department of Orthopaedic and Trauma Surgery, Ospedale Civile, Jesi, Italy; recruitment: from January 2007‐April 2008 |
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Participants |
Participants: 88 undergoing arthroscopic repair of rotator cuff tears Included participants: participants with repairable small or medium rotator cuff tears (supraspinatus), as assessed in the operative procedure Excluded participants: presence of inflammatory joint disease; irreparable or partial lesions; acromioclavicular arthritis; rotator cuff arthropathy; subscapularis tendon abnormalities; workers' compensation claims; prior surgery on the affected shoulder Age: PRT group mean (range): 55.2 years (37‐69) No PRT mean (range): 55.5 years (41‐72) Gender: PRT group(number of men:women):23:22 No PRT (number of men:women): 17:26 Sports activity: not available |
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Interventions | All patients underwent arthroscopic repair with double row fixation. PRT was applied as an augmentation procedure PRT (number of participants = 43): single platelet‐rich fibrin matrix ‐ 9 mL blood centrifuged for 6 minutes PRP separated and CaCl2 was added for a 2‐phase centrifugation PRT preparation: kit: Cascade Autologous Platelet System Quantification of platelet concentrates after preparation: not assessed No PRT (number of participants = 45): no platelet‐rich therapy controls Co‐interventions: same rehabilitation protocol |
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Outcomes | Constant Score MRI (integrity of the rotator cuff repair, retear) |
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Other quality issues |
Sample size: adequate power for Constant Validation of PRT: PRT concentration/validation was not reported |
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Notes | The authors have provided the study protocol/trial registration details, ID: ISRCTN49643328 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation | Low risk | The authors used a random numbers table to allocate study participants |
Allocation concealment | Low risk | Used sequentially‐numbered, opaque and sealed envelopes |
Blinding All outcomes | Unclear risk | Clinical assessors and participants were probably not blinded to the procedure, but MRI assessors were blinded to the procedure |
Incomplete outcome data addressed All outcomes | Low risk | No missing outcome data |
Free of selective reporting | Low risk | The study protocol was available and all of the study’s prespecified (primary and secondary) outcomes that are of interest in the review have been reported in the pre‐specified way |
Free of other bias | Low risk | The study appears to be free of other sources of bias |