Sensory Deficit Following ACL Reconstruction: PRF Pilot Study (PRF-ACL)

University of Belgrade

Status: Completed

Conditions: Knee Injuries; Anterior Cruciate Ligament Injury; Platelet-Rich Fibrin (PRF); Bone-Patellar Tendon-Bone Autograft; Sensory Disorders

Treatments: Procedure: Standard Closure (Control); Biological: Platelet-rich fibrin (PRF)

Study type: Observational

Funder types: Other

Identifiers

NCT07257666

Eticka komisija 17/VI-3

17/VI-3 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 53 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

53 participants in 2 patient groups

PRF Group

Description:

Patients undergoing ACL reconstruction with a bone-patellar tendon-bone (BPTB) autograft, with platelet-rich fibrin (PRF) applied at the donor site (n=24)

Treatment:

Biological: Platelet-rich fibrin (PRF)

Control Group

Description:

Patients undergoing ACL reconstruction with a BPTB autograft, treated with standard closure without PRF (n=29)

Treatment:

Procedure: Standard Closure (Control)