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NCT Number: NCT06190223

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

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.

Recruiting

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara City Hospital

Ankara, Turkey (Türkiye)

Location status: Recruiting

Location contact

Enejd Veizi

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Anterior cruciate ligament (ACL) reconstruction with a periost-patellar-tendon-bone (PPTB) autograft and a tibial press-fit technique

Procedure

A longitudinal incision will be performed starting from the central part of the patella. A ruler will be used to mark a tendon thickness of 10mm from the middle of the patellar tendon. Superiorly, the patellar periosteum will be marked with a length of 30-40mm and a width of 10mm. Inferiorly, the tibial tubercle will be marked in a trapezoidal shape with a length of approximately 35mm, a superior narrow base of 10mm and an inferior wider base of 12mm. After extraction, the superior part of the graft will be prepared with reinforced sutures in a whipstitch pattern, while the bone block will be shaped according to the planned tunnel width. After adequate preparation, the femoral end of the graft will be shuttled in with an adjusted fixation device, while the tibial end will be hammered in with a small mallet, in a press-fit fashion, stopping short of the joint surface, but tensioned appropriately. The femoral adjustable device will then be tensioned to ensure proper graft sitting.

Primary outcomes

  1. 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

  2. The International Knee Documentation Committee Score (IKDC)

    Time frame: Postoperative 1.st year

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

  3. Tegner-Lysholm Scale

    Time frame: Postoperative 1.st year

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

  4. Graft survival

    Time frame: Postoperative 1.st year

    Overall graft survival

Secondary outcomes

  1. Tunnel widening

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Enejd Veizi, MD

CONTACT

[email protected]

+905439799959

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Collaborators

  • Ankara Etlik City Hospital
  • Ataturk University
  • Baltalimani Bone Diseases Research and Training Hospital
  • Fatih Sultan Mehmet Training and Research Hospital
  • Karadeniz Technical University
  • Konya City Hospital
  • Kutahya Health Sciences University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 5, 2024
Registry last updated
Jan 29, 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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