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Sensory Deficit Following ACL Reconstruction: PRF Pilot Study

NCT07257666 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 53

Last updated 2025-12-15

No results posted yet for this study

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)

Interventions

BIOLOGICAL

Platelet-rich fibrin (PRF)

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

PROCEDURE

Standard Closure (Control)

Conventional closure of the donor site without PRF application

Sponsors & Collaborators

  • University of Belgrade

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-07
Primary Completion
2023-01-07
Completion
2025-07-14

Countries

  • Serbia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07257666 on ClinicalTrials.gov