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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-55
SponsorAnkara City Hospital Bilkent

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

All patients with a diagnosis of ruptured ACL scheduled for surgery with the aforementioned technique.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Procedure/Surgery

    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.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: PPTB Group1 intervention

Trial outcomes

Primary outcomes

1

The Knee injury and Osteoarthritis Outcome Score (KOOS)

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

Time frame
Postoperative 1.st year
2

The International Knee Documentation Committee Score (IKDC)

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

Time frame
Postoperative 1.st year
3

Tegner-Lysholm Scale

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

Time frame
Postoperative 1.st year
4

Graft survival

Overall graft survival

Time frame
Postoperative 1.st year

Secondary outcomes

1

Tunnel widening

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.

Time frame
Postoperative 1.st year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ankara City Hospital Bilkent

Lead sponsor

Konya City Hospital

Collaborator

Baltalimani Bone Diseases Research and Training Hospital

Collaborator

Ataturk University

Collaborator

Karadeniz Technical University

Collaborator

Ankara Etlik City Hospital

Collaborator

Fatih Sultan Mehmet Training and Research Hospital

Collaborator

Kutahya Health Sciences University

Collaborator