Anterior Cruciate Ligament Reconstruction With a Periosteal - Patellar Tendon - Bone Autograft - The Kocabey Press-Fit Technique

Recruiting

• Conditions: Anterior Cruciate Ligament Rupture

• Registration Number: NCT06190223
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

This study aims to evaluate the clinical and radiological outcomes of patients undergoing anatomical single-bundle anterior cruciate ligament reconstruction with periosteal-patellar tendon-bone autograft and press-fit tibial fixation technique. The study also aims to compare these outcomes with other reconstruction techniques in the literature. The research investigates the results of a novel surgical technique, providing a minimally invasive and faster rehabilitation for patients undergoing surgery due to anterior cruciate ligament rupture. The technique does not use any screws or staples for tibial fixation, but it carries similar risks as existing techniques. The technique, similar to the well-known bone-patellar tendon-bone (BPTB) autograft technique, creates minimal bone defect at the tibial tuberosity. Over time, the defect remodels and causes minimal clinical discomfort. Despite these limitations, the authors expect patients operated with the investigated new technique to experience less postoperative swelling, less pain, faster mobilization, and earlier rehabilitation.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-23
• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2024-01-03
• Study First Posted: 2024-01-05
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Primary Completion: 2025-11-25
• Study Completion: 2025-11-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• patients who underwent anatomical single-bundle anterior cruciate ligament reconstruction with periosteal - patellar tendon - bone autograft and press-fit tibial fixation technique after anterior cruciate ligament rupture
• patients with at least 1 year of clinical and radiological follow-up
• patients who did not undergo a revision

Exclusion Criteria

• Patients who underwent a secondary arthroscopy for any reason after primary surgery
• Patients with a history of septic arthritis (before and after the surgery)
• Those with a history of trauma after primary surgery to the operated knee
• Patients who have not completed at least 1 year of follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tegner-Lysholm Scale	Postoperative 1.st year	minimum value:0, maximum value 100, higher values mean better outcome
The Knee injury and Osteoarthritis Outcome Score (KOOS)	Postoperative 1.st year	minimum value:0, maximum value 100, higher values mean better outcome
The International Knee Documentation Committee Score (IKDC)	Postoperative 1.st year	minimum value:0, maximum value 100, higher values mean better outcome
Graft survival	Postoperative 1.st year	Overall graft survival

Secondary Outcome Measures

Name	Time	Method
Tunnel widening	Postoperative 1.st year	Tibial and femoral tunnel widening will be measured on direct calibrated Xrays as a distance (in millimeters) and on CT scans taken at the sixth postoperative month. The distance will be measured on the widest point between the sclerotic lines on the Xrays and perpendicular to their longitudinal trajectories.

Trial Locations

Locations (1)

Ankara City Hospital; 🇹🇷 Ankara, Turkey