The Effect of Platelet-rich Fibrin on the Regeneration of Patellar Ligament Defects and the Functional Recovery of Patients After Anterior Cruciate Ligament Reconstruction of the Knee
The Effect of Platelet-rich Fibrin on the Regeneration of Patellar Ligament Defects and the Functional Recovery of Patients After Anterior Cruciate Ligament Reconstruction of the Knee
Pilot, single-center, non-randomized, parallel-group clinical study designed to assess whether intraoperative application of autologous platelet-rich fibrin (PRF) at the bone-patellar tendon-bone (BPTB) donor site reduces postoperative anterior knee sensory deficit after anterior cruciate ligament (ACL) reconstruction in competitively active male athletes. Planned enrollment is 53 participants allocated to a PRF cohort or a standard-care cohort. The primary outcome is the proportion of participants without anterior knee sensory deficit at 12 months post-surgery.
Background: Sensory deficit around the BPTB donor site is a recognized complication after ACL reconstruction and may affect patient satisfaction and functional recovery. PRF is an autologous bioregenerative product with potential to support soft-tissue healing.
Objective: To determine whether PRF application at the donor site reduces anterior knee sensory deficit compared with standard surgical care.
Design and Participants: Single-center, prospective, pilot, non-randomized study with two parallel cohorts (PRF vs standard care). Competitively active male athletes meeting prespecified eligibility criteria are followed at 4, 8, and 12 months post-surgery. Recruitment window: January 2022 to January 2023.
Interventions: In the PRF cohort, PRF is prepared intraoperatively and applied to the donor site per manufacturer protocol; the comparator cohort receives standard closure without PRF.
Assessments:
Primary outcome: Proportion of participants without anterior knee sensory deficit at 12 months. Sensory testing is performed over a predefined 9-point area lateral to the surgical scar (eyes closed; contralateral knee used as reference if uncertain).
Secondary outcomes: Patient-reported knee function instruments (International Knee Documentation Committee [IKDC] Subjective Knee Form and Lysholm Knee Scoring Scale), each reported as total score (0-100; higher scores indicate better function) at 4, 8, and 12 months; optional MRI-based assessments of the donor site per protocol; safety monitoring of adverse events.
Analysis (planned): Group comparisons using appropriate categorical and non-parametric methods with prespecified approaches to handle multiplicity.
Inclusion Criteria:
Exclusion Criteria: