Anterior Cruciate Ligament Reconstruction With a Periosteal - Patellar Tendon - Bone Autograft - The Kocabey Press-Fit Technique
NCT ID: NCT06190223
Last Updated: 2025-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
150 participants
OBSERVATIONAL
2023-11-23
2025-11-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Over-the-Top vs. Anteromedial ACLR With Lateral Extraarticular Tenodesis
NCT06664047
Reconstruction of the ACL With QT Graft With Bone Plug vs BPTB
NCT06189573
Anthropometric Predictability of Full-Thickness Peroneus Longus and Semitendinosus Autograft Size
NCT06769724
Anterior Cruciate Ligament Reconstruction Made With Hamstring Tendon And Quadriceps Tendon Autografts
NCT04940169
Comparison of Remnant-Preserving Anterior Cruciate Ligament Reconstruction With Healthy Controls
NCT05245461
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PPTB Group
Patients will undergo anterior cruciate ligament reconstruction with the novel PPTB graft and a tibial press-fit technique.
Anterior cruciate ligament (ACL) reconstruction with a periost-patellar-tendon-bone (PPTB) autograft and a tibial press-fit technique
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Anterior cruciate ligament (ACL) reconstruction with a periost-patellar-tendon-bone (PPTB) autograft and a tibial press-fit technique
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* patients with at least 1 year of clinical and radiological follow-up
* patients who did not undergo a revision
Exclusion Criteria
* 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
18 Years
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Konya City Hospital
OTHER
Baltalimani Bone Diseases Research and Training Hospital
OTHER_GOV
Ataturk University
OTHER
Karadeniz Technical University
OTHER
Ankara Etlik City Hospital
OTHER_GOV
Fatih Sultan Mehmet Training and Research Hospital
OTHER
Kutahya Health Sciences University
OTHER
Ankara City Hospital Bilkent
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Enejd Veizi, MD
Assistant Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ankara City Hospital
Ankara, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Akoto R, Muller-Hubenthal J, Balke M, Albers M, Bouillon B, Helm P, Banerjee M, Hoher J. Press-fit fixation using autologous bone in the tibial canal causes less enlargement of bone tunnel diameter in ACL reconstruction--a CT scan analysis three months postoperatively. BMC Musculoskelet Disord. 2015 Aug 19;16:200. doi: 10.1186/s12891-015-0656-5.
Barie A, Sprinckstub T, Huber J, Jaber A. Quadriceps tendon vs. patellar tendon autograft for ACL reconstruction using a hardware-free press-fit fixation technique: comparable stability, function and return-to-sport level but less donor site morbidity in athletes after 10 years. Arch Orthop Trauma Surg. 2020 Oct;140(10):1465-1474. doi: 10.1007/s00402-020-03508-1. Epub 2020 Jun 5.
Arnold MP, Burger LD, Wirz D, Goepfert B, Hirschmann MT. The biomechanical strength of a hardware-free femoral press-fit method for ACL bone-tendon-bone graft fixation. Knee Surg Sports Traumatol Arthrosc. 2017 Apr;25(4):1234-1240. doi: 10.1007/s00167-015-3960-6. Epub 2016 Jan 7.
Haberli J, Heilgemeir M, Valet S, Aiyangar A, Overes T, Henle P, Eggli S. Novel press-fit technique of patellar bone plug in anterior cruciate ligament reconstruction is comparable to interference screw fixation. Arch Orthop Trauma Surg. 2022 Aug;142(8):1963-1970. doi: 10.1007/s00402-021-04137-y. Epub 2021 Aug 30.
Kocabey Y, Yildirim C, Erden T, Kaya A. Tibial Press-Fit Fixation Technique in Anterior Cruciate Ligament Reconstruction. Arthrosc Tech. 2023 Apr 24;12(5):e737-e743. doi: 10.1016/j.eats.2023.02.001. eCollection 2023 May.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
E2-23-5650
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.