Ankara City Hospital
Ankara, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT06190223
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.
Interested in participating?
Request Info18 year–55 year
All sexes
Observational
Ankara, Turkey (Türkiye)
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Postoperative 1.st year
minimum value:0, maximum value 100, higher values mean better outcome
Time frame: Postoperative 1.st year
minimum value:0, maximum value 100, higher values mean better outcome
Time frame: Postoperative 1.st year
minimum value:0, maximum value 100, higher values mean better outcome
Time frame: Postoperative 1.st year
Overall graft survival
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.
Contact information is provided by the study sponsor or research team.
Ankara City Hospital Bilkent
Other
Anatomic Single Bundle Anterior Cruciate Ligament Reconstruction With a Press-fit Tibial Fixation Technique Using Periosteal - Patellar Tendon - Bone Autograft
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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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