Vogrin 2010.
Methods | Quasi‐randomised controlled trial: sequence generated by the presence of odd or even numbers. Participants followed for 6 months after the procedure Trial conducted: Department of Orthopedic Surgery, University Hospital Maribor, Maribor, Slovenia; recruitment: February‐June 2008 |
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Participants |
Participants: 55 undergoing ACL reconstruction Inclusion criteria: participants with unstable knee resulting from ACL rupture; aged 18‐50 years Exclusion criteria: inflammatory diseases; diabetes mellitus; developed knee osteoarthrosis; malignant diseases; allergy to contrast media, renal diseases and thrombocytopenia Age: PRT group (mean ± SD): 35.4 years ± 10.0 No PRT (mean ± SD): 33.0 years ± 12.5 Gender: PRT group (number of men:women): 13:9 No PRT (number of men:women): 17:6 Sports activity: not available |
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Interventions | Arthroscopic ACL reconstruction with semitendinosus and gracilis tendons (fixed with 2 cross pins in the femur and 1 interference screw in the tibia) PRT (number of participants = 28): single, intraoperative application in the bone tunnels after graft placement. 52 mL blood mixed with 8 mL calcium citrate as anticoagulant. The authors pre‐defined the PRP volume as 6 mL, and the process resulted in 6 mL of PRP. The product was activated with human thrombin and applied in the surgical site PRT preparation: kit: Magellan autologous platelet separator (Medtronic Biologic Therapeutics and Diagnostics, Minneapolis, MN, USA) Quantification of platelet concentrates after preparation: 962 (552‐1326) g/L; participants' average blood platelet concentration:192 g/L No PRT (number of participants = 27): no platelet‐rich therapy controls Co‐interventions: same rehabilitation protocol |
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Outcomes | Knee stability (KT‐ 2000) 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: quantification reported |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation | High risk | Sequence generated by odd or even date ‐ quasi‐randomised |
Allocation concealment | High risk | Quasi‐randomised clinical trial |
Blinding All outcomes | High risk | The participants and outcome assessors were not 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 | High risk | The study protocol is not available and the clinical follow‐up period was short for participants who underwent to ACL surgery |
Free of other bias | Low risk | The study appears to be free of other bias |