Cervellin 2012.
Methods | Randomised controlled trial: 2 blocks of 20 participants that were randomly selected by an external researcher. It is not clear how the allocation blocks were created. Participants followed for 12 months. Participants and radiologists were blinded to the intervention Trial conducted: Department of Sports Traumatology and Arthroscopic Surgery of the Galeazzi Orthopaedic Institute of Milan: recruitment: 2008‐2009 |
|
Participants |
Participants: 40 undergoing arthroscopic ACL reconstruction Included participants: adults requiring ACL reconstruction Excluded participants: associated ligament damage; associated immune‐rheumatologic pathologies; chondropathies (Outerbrigde > III); pre‐existing anterior knee pain; femoropatellar pathologies and previous surgery on the same knee Age: PRT group mean (range): 22.9 years (18‐29) No PRT mean (range): 22.7 years (19‐27) Gender: PRT group: not available No PRT: not available Sports activity: included patients were in "high level" of sports activity |
|
Interventions | All patients underwent ACL reconstruction with bone‐patellar tendon graft PRT (number of participants = 20): single, intra operative intervention, 54 mL blood plus 6 mL citrate anticoagulant, 15 minutes centrifugation. Buffy coat containing PRP was centrifuged with participant's thrombin (from another venous puncture) and applied after jellified. PRP gel was applied in the patellar and tendon bone plug harvest site and fixed with peritenon suture PRT preparation: kit: Gravitional Platelet Separation (GPS II). Addiction of CaCl2 and autologous thrombin Quantification of platelet concentrates after preparation: not assessed No PRT (number of participants = 20): no platelet‐rich therapy controls Co‐Interventions: same rehabilitation protocol |
|
Outcomes | VISA VAS MRI (assessment of new bone formation in the graft site; gap filling > 70% considered as satisfactory) |
|
Other quality issues |
Sample size: the authors did not calculate the sample size Validation of PRT: PRT concentration or its validation was not reported |
|
Notes | ||
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 | Unclear risk | Participants and radiologists were blinded to the intervention |
Incomplete outcome data addressed All outcomes | Low risk | No missing outcome data |
Free of selective reporting | Unclear risk | The study protocol was not available. Relevant outcomes were reported |
Free of other bias | Low risk | The study appears to be free of other sources of bias |