Sensory Deficit Following ACL Reconstruction: PRF Pilot Study

NCT ID: NCT07257666

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 53 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-07
• Study Completion Date: 2025-07-14

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.

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

Platelet-rich fibrin (PRF)

Intervention Type: BIOLOGICAL

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

Control Group

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

Standard Closure (Control)

Intervention Type: PROCEDURE

Conventional closure of the donor site without PRF application

Interventions

Platelet-rich fibrin (PRF)

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

Intervention Type: BIOLOGICAL

Standard Closure (Control)

Conventional closure of the donor site without PRF application

Intervention Type: PROCEDURE

Other Intervention Names

Autologous PRF

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Faculty of Medicine, University of Belgrade

UNKNOWN

Sponsor Role: collaborator

University of Belgrade

OTHER

Sponsor Role: lead

Responsible Party

Darko Milovanovic

Principal Investigator, University Clinical Center of Serbia, Docent, Faculty of Medicine, University of Belgrade

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Clinical Center of Serbia (UKCS)

Belgrade, , Serbia

Countries

Serbia

References

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.

Reference Type: BACKGROUND

PMID: 35916963 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Study Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

17/VI-3

Identifier Type: OTHER

Identifier Source: secondary_id

Eticka komisija 17/VI-3

Identifier Type: -

Identifier Source: org_study_id