Sensory Deficit Following ACL Reconstruction: PRF Pilot Study

University of Belgrade53 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18-40 years * Isolated anterior cruciate ligament rupture confirmed by MRI and clinical examination * Planned ACL reconstruction with BPTB autograft * Written informed consent provided Exclusion Criteria: * Previous knee surgery on the affected knee * Associated ligament injuries requiring additional reconstruction * Significant cartilage damage (Outerbridge grade III-IV beyond donor site changes) * Systemic disease affecting wound healing (e.g., diabetes mellitus, autoimmune disease) * Active infection * Refusal or inability to provide informed consent

Outcomes

Primary Outcomes

Proportion of participants without anterior knee sensory deficit at the donor site

Sensory function assessed over a predefined 9-point area lateral to the surgical scar; deficit coded as 1 if \>3 points are reported as "no or altered touch," otherwise 0. Assessment performed with eyes closed; contralateral knee used for reference if uncertain. Measure Type \& Units: Percentage of participants (%)

Time frame: 12 months post-surgery

Secondary Outcomes

International Knee Documentation Committee (IKDC) Subjective Knee Form score (0-100; higher scores indicate better function)

Patient-reported outcome; total score ranges from 0 (worst) to 100 (best).

Time frame: Baseline, 4, 8, and 12 months post-surgery