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NCT07906860

Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction

Sponsor: Yonsei University

View on ClinicalTrials.gov

Summary

This prospective, single-center, single-arm observational cohort study aims to evaluate the clinical, radiological, and arthroscopic outcomes and safety of primary anterior cruciate ligament (ACL) reconstruction augmented with the BioBrace® Reinforced BioInductive Implant. A total of 30 patients who decided to undergo BioBrace-augmented ACL reconstruction in routine clinical practice will be followed for up to 24 months postoperatively. Knee stability, graft maturation via MRI and second-look arthroscopy, patient-reported outcomes, and complications will be assessed.

Official title: Clinical and Biological Outcomes of BioBrace®-Augmented Anterior Cruciate Ligament Reconstruction: A Prospective Cohort Study

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-11-01

Completion Date

2029-04-30

Last Updated

2026-10-30

Healthy Volunteers

Conditions

Anterior Cruciate Ligament Injuries Anterior Cruciate Ligament Rupture

Interventions

DEVICE

BioBrace® Reinforced BioInductive Implant

BioBrace® Reinforced BioInductive Implant (5 x 250 mm; CONMED Corporation) is used as an augment for primary ACL reconstruction. The bioinductive scaffold is whipstitched at both ends, folded in half, positioned alongside the autograft/allograft tendon, and passed through femoral and tibial tunnels for standard fixation to reinforce early mechanical stability and facilitate graft maturation.

Inclusion Criteria: 1. Patients with anterior cruciate ligament (ACL) injury confirmed by physical examination and MRI, scheduled for primary ACL reconstruction. 2. Skeletally mature patients who are suitable for standard ACL reconstruction without physeal-sparing techniques. 3. Patients who, during routine clinical practice prior to study enrollment, have already voluntarily decided to undergo BioBrace®-augmented primary ACL reconstruction after receiving full explanations regarding the purpose, expected benefits, risks, limitations of evidence, uncovered costs, and alternative treatment options. 4. Patients who have received adequate explanation of the study objectives, procedures, potential risks, and benefits, and voluntarily signed written informed consent. 5. Adults aged 19 years or older. Exclusion Criteria: 1. Revision ACL reconstruction in the affected knee. 2. History of prior ligament reconstruction or major knee surgery in the ipsilateral knee that may significantly influence study outcomes. 3. Contralateral knee with ACL tear, ACL deficiency, prior ACL reconstruction, or major knee surgery that may affect outcome assessment. 4. Multi-ligament injuries requiring simultaneous ligament reconstruction other than the ACL. 5. Requirement for concomitant major procedures that may affect clinical outcomes (e.g., osteotomy, meniscus allograft transplantation, cartilage restoration) other than standard meniscal repair or partial meniscectomy. 6. Advanced osteoarthritis of the knee joint. 7. Concomitant periarticular fracture of the knee requiring surgery, or a history of surgery for such fractures. 8. Active infection, inflammatory arthritis, neuromuscular disorders, or other systemic conditions that may significantly affect tendon healing and postoperative rehabilitation. 9. Known hypersensitivity or allergy to bovine-derived materials, polyethylene glycol, poly-L-lactic acid (PLLA), or any component of the BioBrace® implant. 10. Contraindications to magnetic resonance imaging (MRI). 11. Inability to adhere to the planned rehabilitation protocol or attend 24-month follow-up visits. 12. Inability to provide voluntary written informed consent. 13. Age younger than 19 years. 14. Other medical or clinical conditions deemed inappropriate for participation by the principal investigator.