Skip to main content
Clinical Trials/NCT06190223
NCT06190223
Recruiting
Not Applicable

Anatomic Single Bundle Anterior Cruciate Ligament Reconstruction With a Press-fit Tibial Fixation Technique Using Periosteal - Patellar Tendon - Bone Autograft

Ankara City Hospital Bilkent1 site in 1 country150 target enrollmentNovember 23, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anterior Cruciate Ligament Rupture
Sponsor
Ankara City Hospital Bilkent
Enrollment
150
Locations
1
Primary Endpoint
Tegner-Lysholm Scale
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 23, 2023
End Date
November 25, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Enejd Veizi, MD

Assistant Professor

Ankara City Hospital Bilkent

Eligibility Criteria

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

Outcomes

Primary Outcomes

Tegner-Lysholm Scale

Time Frame: Postoperative 1.st year

minimum value:0, maximum value 100, higher values mean better outcome

The Knee injury and Osteoarthritis Outcome Score (KOOS)

Time Frame: Postoperative 1.st year

minimum value:0, maximum value 100, higher values mean better outcome

The International Knee Documentation Committee Score (IKDC)

Time Frame: Postoperative 1.st year

minimum value:0, maximum value 100, higher values mean better outcome

Graft survival

Time Frame: Postoperative 1.st year

Overall graft survival

Secondary Outcomes

  • Tunnel widening(Postoperative 1.st year)

Study Sites (1)

Loading locations...

Similar Trials