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

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.

Study Overview

• Status: Completed
• Conditions: Knee Injuries; Anterior Cruciate Ligament Injury; Sensory Disorders; Bone-Patellar Tendon-Bone Autograft; Platelet-Rich Fibrin (PRF)
• Intervention / Treatment: Biological: Platelet-rich fibrin (PRF); Procedure: Standard Closure (Control)

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• Serbia
  • Belgrade, Serbia, 11000
    • University Clinical Center of Serbia (UKCS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing ACL reconstruction with bone-patellar tendon-bone (BPTB) autograft at the University Clinical Center of Serbia

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PRF Group; Patients undergoing ACL reconstruction with a bone-patellar tendon-bone (BPTB) autograft, with platelet-rich fibrin (PRF) applied at the donor site (n=24)	Biological: Platelet-rich fibrin (PRF); Autologous PRF prepared intraoperatively from patient's venous blood and applied at the donor site after graft harvesting.; Other Names: Autologous PRF
Control Group; Patients undergoing ACL reconstruction with a BPTB autograft, treated with standard closure without PRF (n=29)	Procedure: Standard Closure (Control); Conventional closure of the donor site without PRF application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (%)	12 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline, 4, 8, and 12 months post-surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lysholm Knee Scoring Scale (0-100; higher scores indicate better function)	Patient-reported outcome; total score ranges from 0 (worst) to 100 (best).	Baseline, 4, 8, 12 months after surgery

Collaborators and Investigators

• Sponsor: University of Belgrade
• Collaborators: Faculty of Medicine, University of Belgrade

Publications and helpful links

General Publications

• Shichman I, Baruchi D, Rachevsky G, Amzallag N, Brandstetter AS, Vidra M, Morag G. Bone filling decreases donor site morbidity after anterior cruciate ligament reconstruction with bone-patellar tendon-bone autografts. Arch Orthop Trauma Surg. 2023 May;143(5):2565-2572. doi: 10.1007/s00402-022-04572-5. Epub 2022 Aug 2.

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2022
• Primary Completion (Actual): January 7, 2023
• Study Completion (Actual): July 14, 2025

Study Registration Dates

• First Submitted: September 23, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Estimated): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: ACL reconstruction; Platelet-Rich Fibrin; Knee Surgery; Donor Site Morbidity; Bone-Patellar Tendon-Bone autograft; Anterior Cruciate Ligament Injury; Sensory Deficit
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Wounds and Injuries; Leg Injuries; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Anterior Cruciate Ligament Injuries; Sensation Disorders; Knee Injuries
• Other Study ID Numbers: Eticka komisija 17/VI-3; 17/VI-3 (Other Identifier: Ethics Committee of the Faculty of Medicine, University of Belgrade - Approval No. 17/VI-3)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to privacy considerations and institutional regulations. Summary results will be published in peer-reviewed journals.

Study Data/Documents

1. Informed Consent Form
   Information identifier: Ethics Committee approval No.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No