Almeida 2012.
Methods | Randomised controlled trial: allocation concealment by computer‐generated randomisation. Participants were followed for 6 months Trial conducted: Sao Paulo University Medical School, Brazil; recruitment November 2008‐February 2010 |
|
Participants |
Participants: 27 undergoing ACL reconstruction Included participants: patients with ACL injuries, bone maturity and aged < 45 years Excluded participants: complex ligament lesions, osteoarthritis, previous surgeries at the same joint, post operative infection, arthrofibrosis, reoperation, inadequate follow‐up and thrombocytopenia Age: PRT group mean (range): 25.8 years (18‐44) No PRT mean (range): 23.1 years (15‐34) Gender: PRT group (number of participants men:women): 10:2 No PRT(number of participants men:women): 14:1 Sports activity: not available |
|
Interventions | All participants underwent ACL reconstruction with bone‐patellar tendon bone graft 1. PRT (number of participants = 12). Single and intraoperative intervention: 450 mL blood, resulted in 30‐50 mL PRP. Remaining blood was returned to the participant. To generate PRP gel, CaCl2 and autologous thrombin was added. PRP gel applied in patellar tendon harvest site PRT preparation: kit: Haemonetics MCS+/ 995‐E Quantification of platelet concentrates after preparation: platelet concentration 1,185,166/mm3 (SD 404.472/mm3), which represented an average increase of 7.65 (range 3.82‐26.03) times the basal levels of platelets; white blood cells 0.91/mm3 (SD 0.81/mm3) 2. No PRT (number of participants = 15): no platelet‐rich therapy controls Co‐interventions: same rehabilitation protocol |
|
Outcomes | VAS MRI (to assess the patellar tendon harvest site healing: gap area of the patellar tendon harvest site, cross‐sectional area of the patellar tendon, patellar height by the Insall‐Salvati index) Lysholm Questionnaire IKDC Kujala Questionnaire Tegner Questionnaire Isokinetic strength measurements |
|
Other quality issues |
Sample size: the authors did not calculate the sample size Validation of PRT: available |
|
Notes | The authors provided extra information after request (academic thesis): measures of dispersion (standard deviation) for VAS, Lysholm, IKDC, Kujala and Tegner scores The authors provided the study protocol / trial registration details, ID: NCT01111747 |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation | Low risk | Computer‐generated sequence was used |
Allocation concealment | Unclear risk | Not reported |
Blinding All outcomes | Unclear risk | Probably not blinded |
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 available and one primary outcome (pain) was measured only within the first 24 hours after surgery, which was preplanned in the study's protocol. In addition, the clinical follow‐up period is short for participants who underwent ACL surgery |
Free of other bias | Low risk | The study appears to be free of other sources of bias |