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Completed

NCT Number: NCT07257666

Sensory Deficit Following ACL Reconstruction: PRF Pilot Study

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.

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Key information

Conditions

Anterior Cruciate Ligament Injury Anterior Cruciate Ligament Injuries Bone-Patellar Tendon-Bone Autograft Knee Injuries Leg Injuries Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Platelet-Rich Fibrin (PRF) Sensation Disorders Sensory Disorders Signs and Symptoms Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

Male

Study type

Observational

Primary location

University Clinical Center of Serbia (UKCS)

Belgrade, 11000, Serbia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet-rich fibrin (PRF)

Biological

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

Other names: Autologous PRF

Standard Closure (Control)

Procedure

Conventional closure of the donor site without PRF application

Primary outcomes

  1. Proportion of participants without anterior knee sensory deficit at the donor site

    Time frame: 12 months post-surgery

    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 (%)

Secondary outcomes

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

    Time frame: Baseline, 4, 8, and 12 months post-surgery

    Patient-reported outcome; total score ranges from 0 (worst) to 100 (best).

Other outcomes

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

    Time frame: Baseline, 4, 8, 12 months after surgery

    Patient-reported outcome; total score ranges from 0 (worst) to 100 (best).

Sponsors and collaborators

Lead sponsor

University of Belgrade

Other

Registry information

Official study title

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

Acronym: PRF-ACL

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Dec 2, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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