Platelet-rich therapy in the treatment of patients with hip fractures: a single centre, parallel group, participant-blinded, randomised controlled trial.

Objective: To quantify and draw inferences on the clinical effectiveness of platelet-rich therapy in the management of patients with a typical osteoporotic fracture of the hip.

Design: Single centre, parallel group, participant-blinded, randomised controlled trial.

Setting: UK Major Trauma Centre.

Participants: 200 of 315 eligible patients aged 65 years and over with any type of intracapsular fracture of the proximal femur. Patients were excluded if their fracture precluded internal fixation.

Interventions: Participants underwent internal fixation of the fracture with cannulated screws and were randomly allocated to receive an injection of platelet-rich plasma into the fracture site or not.

Main Outcome Measures: Failure of fixation within 12 months, defined as any revision surgery.

Results: Primary outcome data were available for 82 of 101 and 78 of 99 participants allocated to test and control groups, respectively; the remainder died prior to final follow-up. There was an absolute risk reduction of 5.6% (95% CI -10.6% to 21.8%) favouring treatment with platelet-rich therapy (χ(2) test, p=0.569). An adjusted effect estimate from a logistic regression model was similar (OR=0.71, 95% CI 0.36 to 1.40, z test; p=0.325). There were no significant differences in any of the secondary outcome measures excepting length of stay favouring treatment with platelet-rich therapy (median difference 8 days, Mann-Whitney U test; p=0.03). The number and distribution of adverse events were similar. Estimated cumulative incidence functions for the competing events of death and revision demonstrated no evidence of a significant treatment effect (HR 0.895, 95% CI 0.533 to 1.504; p=0.680 in favour of platelet-rich therapy).

Conclusions: No evidence of a difference in the risk of revision surgery within 1 year in participants treated with platelet-rich therapy compared with those not treated. However, we cannot definitively exclude a clinically meaningful difference.

Trial Registration: Current Controlled Trials, ISRCTN49197425, http://www.controlled-trials.com/ISRCTN49197425.