Sensory Deficit Following ACL Reconstruction: PRF Pilot Study

NCT07257666 | Completed

• 2 other identifiers: Eticka komisija 17/VI-317/VI-3
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Platelet-Rich Fibrin; ACL reconstruction; Bone-Patellar Tendon-Bone autograft; Anterior Cruciate Ligament Injury; Knee Surgery; Sensory Deficit; Donor Site Morbidity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Baseline, 4, 8, and 12 months post-surgery

Other Outcomes (1)

• Lysholm Knee Scoring Scale (0-100; higher scores indicate better function)

  Baseline, 4, 8, 12 months after surgery

Study Arms (2)

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)

Control Group

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

Procedure: Standard Closure (Control)

Interventions

Platelet-rich fibrin (PRF) BIOLOGICAL

Autologous PRF prepared intraoperatively from patient's venous blood and applied at the donor site after graft harvesting.

Also known as: Autologous PRF

PRF Group

Standard Closure (Control) PROCEDURE

Conventional closure of the donor site without PRF application

Control Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (1)

University Clinical Center of Serbia (UKCS)

Belgrade, 11000, Serbia

Location

Related Publications (2)

• 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.

  PMID: 35916963 BACKGROUND

• Milovanovic D, Kadija M, Gavrilovic D, Sreckovic S, Bilanovic M, Matic A, Vukman P. Sensory Deficit Following Anterior Cruciate Ligament Reconstruction with Bone-Patellar Tendon-Bone Autograft: Platelet-Rich Fibrin (PRF) Could Provide a Solution. Medicina (Kaunas). 2025 Dec 12;61(12):2202. doi: 10.3390/medicina61122202.

  PMID: 41470204 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Knee Injuries; Sensation Disorders

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, University Clinical Center of Serbia, Docent, Faculty of Medicine, University of Belgrade

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: December 2, 2025
• Study Start: January 7, 2022
• Primary Completion: January 7, 2023
• Study Completion: July 14, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)