Vadalà 2013.
Methods | Randomised controlled trial. Sequence generation and allocation methodology were not reported. Participants were followed for a mean of 14.7 months Trial conducted: no details available; recruitment: no details available |
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Participants |
Participants: 40 undergoing ACL reconstruction Inclusion criteria: participants with chronic instability (> 30 days of trauma) Exclusion criteria: age > 50 years; concomitant medial or lateral collateral ligament injuries; degenerative joint disease or chondral damage (MRI or radiographic examinations) Age mean (range): 34.5 years (18‐48) PRT group mean (range): not available No PRT mean (range): not available Gender: all were men PRT group (number of men:women): 20:0 No PRT (number of men:women): 20:0 Sports activity: not available |
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Interventions | All patients underwent arthroscopic ACL reconstruction with hamstring graft PRT (number of participants = 20): single intraoperative application. PRP was applied in the femoral and tibial tunnel. 10 mL blood was centrifuged, thrombin and calcium gluconate added few minutes before its application in order to obtain a thick and adhesive gel PRT preparation: kit: PRP Fast Biotech kit (MyCells PPT‐Platelet Preparation Tube) Quantification of platelet concentrates after preparation: not reported No PRT (number of participants = 20): no platelet‐rich therapy controls Co‐interventions: same rehabilitation protocol |
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Outcomes | Tunnel enlargement (assessed by CT) Tegner activity score Lysholm score IKDC score |
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Other quality issues |
Sample size: the authors did not calculate the sample size Validation of PRT: PRP preparation methodology was not clear and there are some inconsistencies between sections of the manuscript |
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Notes | The authors described different quantities for PRP preparation and application | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation | Unclear risk | Not reported |
Allocation concealment | Unclear risk | Not reported |
Blinding All outcomes | Low risk | Outcome assessors were blinded |
Incomplete outcome data addressed All outcomes | Low risk | No participants were lost to follow‐up |
Free of selective reporting | High risk | The study protocol is not available and the authors did not report outcomes at each time point |
Free of other bias | Low risk | The study appears to be free of other bias |