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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-23

Study Completion Date

2025-11-25

Brief Summary

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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.

Detailed Description

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Conditions

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Anterior Cruciate Ligament Rupture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Konya City Hospital

OTHER

Sponsor Role collaborator

Baltalimani Bone Diseases Research and Training Hospital

OTHER_GOV

Sponsor Role collaborator

Ataturk University

OTHER

Sponsor Role collaborator

Karadeniz Technical University

OTHER

Sponsor Role collaborator

Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role collaborator

Fatih Sultan Mehmet Training and Research Hospital

OTHER

Sponsor Role collaborator

Kutahya Health Sciences University

OTHER

Sponsor Role collaborator

Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Enejd Veizi, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara City Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Enejd Veizi, MD

Role: CONTACT

+905439799959

Facility Contacts

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Enejd Veizi

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 26285568 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32504178 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26744280 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34462826 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37323777 (View on PubMed)

Other Identifiers

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E2-23-5650

Identifier Type: -

Identifier Source: org_study_id

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