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

NCT06190223 | Recruiting DMC

• 1 other identifier: E2-23-5650
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anterior Cruciate Ligament Rupture

Keywords

Anterior cruciate ligament rupture; Press-fit fixation; Patellar tendon graft

Outcome Measures

Primary Outcomes (4)

• The Knee injury and Osteoarthritis Outcome Score (KOOS)

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

  Postoperative 1.st year

• The International Knee Documentation Committee Score (IKDC)

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

  Postoperative 1.st year

• Tegner-Lysholm Scale

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

  Postoperative 1.st year

• Graft survival

  Overall graft survival

  Postoperative 1.st year

Secondary Outcomes (1)

• Tunnel widening

  Postoperative 1.st year

Study Arms (1)

PPTB Group

Patients will undergo anterior cruciate ligament reconstruction with the novel PPTB graft and a tibial press-fit technique.

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

Interventions

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.

PPTB Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead
• 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

Study Sites (1)

Ankara City Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• 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.

  PMID: 26285568 BACKGROUND

• 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.

  PMID: 32504178 BACKGROUND

• 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.

  PMID: 26744280 BACKGROUND

• 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.

  PMID: 34462826 BACKGROUND

• 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.

  PMID: 37323777 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Plastic Surgery Procedures; Polypyrimidine Tract-Binding Protein; Transplantation, Autologous

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; RNA Splicing Factors; RNA-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Nucleoproteins; Transplantation

Central Study Contacts

Enejd Veizi, MD

CONTACT

+905439799959; dr.nad89@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: January 5, 2024
• Study Start: November 23, 2023
• Primary Completion: November 25, 2025
• Study Completion: November 25, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

TU (1)