Anterior Cruciate Ligament InjuriesNCT07906860
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
A study testing BioBrace® Reinforced BioInductive Implant in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, run by Yonsei University.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
- What is being tested?
- BioBrace® Reinforced BioInductive Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with anterior cruciate ligament (ACL) injury confirmed by physical examination and MRI, scheduled for primary ACL reconstruction.
- Skeletally mature patients who are suitable for standard ACL reconstruction without physeal-sparing techniques.
- 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.
- Patients who have received adequate explanation of the study objectives, procedures, potential risks, and benefits, and voluntarily signed written informed consent.
- Adults aged 19 years or older.
Who cannot join
- Revision ACL reconstruction in the affected knee.
- History of prior ligament reconstruction or major knee surgery in the ipsilateral knee that may significantly influence study outcomes.
- Contralateral knee with ACL tear, ACL deficiency, prior ACL reconstruction, or major knee surgery that may affect outcome assessment.
- Multi-ligament injuries requiring simultaneous ligament reconstruction other than the ACL.
- 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.
- Advanced osteoarthritis of the knee joint.
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- Concomitant periarticular fracture of the knee requiring surgery, or a history of surgery for such fractures.
- Active infection, inflammatory arthritis, neuromuscular disorders, or other systemic conditions that may significantly affect tendon healing and postoperative rehabilitation.
- Known hypersensitivity or allergy to bovine-derived materials, polyethylene glycol, poly-L-lactic acid (PLLA), or any component of the BioBrace® implant.
- Contraindications to magnetic resonance imaging (MRI).
- Inability to adhere to the planned rehabilitation protocol or attend 24-month follow-up visits.
- Inability to provide voluntary written informed consent.
- Age younger than 19 years.
- Other medical or clinical conditions deemed inappropriate for participation by the principal investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical and Biological Outcomes of BioBrace®-Augmented Anterior Cruciate Ligament Reconstruction: A Prospective Cohort Study
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.
Read the detailed description
The BioBrace® Reinforced BioInductive Implant is a bioresorbable scaffold composed of type I bovine collagen and poly-L-lactic acid (PLLA) microfilaments designed to provide mechanical reinforcement and facilitate tissue remodeling during graft healing. In this study, 30 skeletal mature patients receiving BioBrace-augmented primary ACL reconstruction will be evaluated preoperatively and postoperatively at 3, 6, 12, and 24 months. Objective anterior and rotational stability will be measured using the KT-2000 arthrometer (side-to-side difference, SSD) and the pivot-shift test. Patient-reported outcome measures (VAS for pain, IKDC subjective score, Lysholm score, and Tegner activity scale) will be recorded. Graft maturation will be assessed via 12-month postoperative MRI (measuring signal-to-noise quotient, SNQ, and structural integrity) and second-look arthroscopy during tibial implant removal at 24 months (using Ahn's Graft Maturation Score, GMS). Adverse events, graft failure/re-tear, and reoperation rates will be monitored throughout the 24-month follow-up period.
- Being tested
- BioBrace® Reinforced BioInductive Implant
- Keywords
- Anterior Cruciate Ligament Reconstruction, BioBrace, Bioinductive Implant, Graft Healing, KT-2000, Second-Look Arthroscopy
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioBrace® Reinforced BioInductive ImplantDevice
Also called BioBrace, Bioinductive collagen-PLLA implant, BioBrace-augmented primary ACL reconstruction
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.
| Study group | Role | What they receive |
|---|---|---|
| 2-mm subchondral drilling | Experimental | Patients undergoing primary anterior cruciate ligament (ACL) reconstruction augmented with the BioBrace® Reinforced BioInductive Implant (5 x 250 mm). The implant is folded and incorporated alongside the prepared ACL graft, then fixed into the femoral and tibial bone tunnels. Concomitant meniscal surgery (repair or partial meniscectomy) or anterolateral ligament (ALL) reconstruction is performed when clinically indicated. Receives: Device: BioBrace® Reinforced BioInductive Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side-to-Side Difference in Anterior Knee Laxity Measured by KT-2000 Arthrometer
Anterior knee laxity is measured as the side-to-side difference (SSD, in millimeters) in anterior tibial translation between the injured and contralateral uninjured knee using the KT-2000 arthrometer under a 30-lb (134 N) anterior load at 30 degrees of knee flexion.
Measured: Up to 24 months postoperatively (assessed at preoperative baseline, 3, 6, 12, and 24 months after surgery)
Rotational Knee Stability Evaluated by Pivot-Shift Test
Rotational knee stability evaluated by the manual pivot-shift test and graded according to International Knee Documentation Committee (IKDC) guidelines: Grade 0 (normal/equal), Grade 1 (glide), Grade 2 (clunk), Grade 3 (gross).
Measured: Up to 24 months postoperatively (assessed at preoperative baseline, 3, 6, 12, and 24 months after surgery)
Secondary outcomes (6)
Graft Signal-to-Noise Quotient (SNQ) on Postoperative MRI
Graft maturation and signal intensity quantified by the signal-to-noise quotient (SNQ) on sagittal-oblique proton density-weighted fat-suppressed MRI images, calculated using the posterior cruciate ligament (PCL) and background noise.
Measured: 12 months after surgery
Structural Integrity and Graft Continuity on Postoperative MRI
Evaluation of the reconstructed ACL graft structural continuity, categorized as intact, partial tear, or complete tear based on 12-month postoperative MRI findings.
Measured: 12 months after surgery
Knee Pain Assessed by Visual Analog Scale (VAS)
Patient-reported pain severity measured on a Visual Analog Scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: Preoperative baseline, and 6, 12, and 24 months after surgery
International Knee Documentation Committee (IKDC) Subjective Knee Score
Self-reported knee symptoms, function, and sports activities assessed using the IKDC Subjective Knee Evaluation Form. Scores range from 0 to 100, where higher scores indicate higher levels of function and lower levels of symptoms.
Measured: Preoperative baseline, and 6, 12, and 24 months after surgery
Lysholm Knee Scoring Scale
Evaluates knee function and daily activity symptoms (limp, support, locking, instability, pain, swelling, stair climbing, squatting). Scores range from 0 to 100, with higher scores reflecting better knee function.
Measured: Preoperative baseline, and 6, 12, and 24 months after surgery
Tegner Activity Scale
Assesses the patient's activity and sports participation level. Scores range from 0 (sick leave or disability due to knee injury) to 10 (participation in competitive sports at national/international elite level). Higher scores indicate higher physical activity levels.
Measured: Preoperative baseline, and 6, 12, and 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-arm prospective cohort study evaluating clinical, radiological, and arthroscopic outcomes in patients undergoing primary ACL reconstruction augmented with BioBrace.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906860
- Sponsor's protocol ID
- 4-2026-1300
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan to share individual participant data with other researchers has not yet been determined.
Publications
Bi AS, Hughes AJ, Savage-Elliott I, Lowe D, Meislin RJ. Anterior Cruciate Ligament Allograft Reconstruction Augmented With a Reinforced, Bioinductive Collagen Scaffold in the Setting of Multiligamentous Knee Injury. Arthrosc Tech. 2024 Jan 1;13(2):102865. doi: 10.1016/j.eats.2023.09.034. eCollection 2024 Feb.
PubMed 38435259Pyrz K, Wood A, Campbell C, Brabston E, Evely T, Casp A, Momaya A. Anterior Cruciate Ligament Reconstruction With Quadriceps Tendon Autograft: Surgical Technique Using Augmentation With a Biocomposite Scaffold. Arthrosc Tech. 2023 Nov 27;12(12):e2335-e2341. doi: 10.1016/j.eats.2023.08.003. eCollection 2023 Dec.
PubMed 38196875Marks Benson E, Pyrz K, Wood A, Momaya A, Brabston E, Evely T, Casp A. Anterior Cruciate Ligament Reconstruction using Bone-Tendon-Bone Allograft: Surgical Technique Using Augmentation with Bio-Composite Scaffold. Arthrosc Tech. 2024 Jan 1;13(3):102877. doi: 10.1016/j.eats.2023.11.005. eCollection 2024 Mar.
PubMed 38584643
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biological Outcomes of BioBrace®-Augmented Anterior Cruciate Ligament Reconstruction: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07906860
- Acronym / sponsor ID
- 4-2026-1300
- Keywords
- Anterior Cruciate Ligament Reconstruction, BioBrace, Bioinductive Implant, Graft Healing, KT-2000, Second-Look Arthroscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The BioBrace® Reinforced BioInductive Implant is a bioresorbable scaffold composed of type I bovine collagen and poly-L-lactic acid (PLLA) microfilaments designed to provide mechanical reinforcement and facilitate tissue remodeling during graft healing. In this study, 30 skeletal mature patients receiving BioBrace-augmented primary ACL reconstruction will be evaluated preoperatively and postoperatively at 3, 6, 12, and 24 months. Objective anterior and rotational stability will be measured using the KT-2000 arthrometer (side-to-side difference, SSD) and the pivot-shift test. Patient-reported outcome measures (VAS for pain, IKDC subjective score, Lysholm score, and Tegner activity scale) will be recorded. Graft maturation will be assessed via 12-month postoperative MRI (measuring signal-to-noise quotient, SNQ, and structural integrity) and second-look arthroscopy during tibial implant removal at 24 months (using Ahn's Graft Maturation Score, GMS). Adverse events, graft failure/re-tear, and reoperation rates will be monitored throughout the 24-month follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-arm prospective cohort study evaluating clinical, radiological, and arthroscopic outcomes in patients undergoing primary ACL reconstruction augmented with BioBrace.
| Arm | Type | Receives |
|---|---|---|
| 2-mm subchondral drilling | Experimental | Device: BioBrace® Reinforced BioInductive ImplantPatients undergoing primary anterior cruciate ligament (ACL) reconstruction augmented with the BioBrace® Reinforced BioInductive Implant (5 x 250 mm). The implant is folded and incorporated alongside the prepared ACL graft, then fixed into the femoral and tibial bone tunnels. Concomitant meniscal surgery (repair or partial meniscectomy) or anterolateral ligament (ALL) reconstruction is performed when clinically indicated. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with anterior cruciate ligament (ACL) injury confirmed by physical examination and MRI, scheduled for primary ACL reconstruction.
- Skeletally mature patients who are suitable for standard ACL reconstruction without physeal-sparing techniques.
- 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.
- Patients who have received adequate explanation of the study objectives, procedures, potential risks, and benefits, and voluntarily signed written informed consent.
- Adults aged 19 years or older.
Key exclusion criteria (14 listed)
- Revision ACL reconstruction in the affected knee.
- History of prior ligament reconstruction or major knee surgery in the ipsilateral knee that may significantly influence study outcomes.
- Contralateral knee with ACL tear, ACL deficiency, prior ACL reconstruction, or major knee surgery that may affect outcome assessment.
- Multi-ligament injuries requiring simultaneous ligament reconstruction other than the ACL.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioBrace® Reinforced BioInductive ImplantAlso: BioBrace, Bioinductive collagen-PLLA implant, BioBrace-augmented primary ACL reconstructionBioBrace® 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. | Device | 2-mm subchondral drilling |
Primary outcome
Side-to-Side Difference in Anterior Knee Laxity Measured by KT-2000 Arthrometer
Time frame: Up to 24 months postoperatively (assessed at preoperative baseline, 3, 6, 12, and 24 months after surgery)
Anterior knee laxity is measured as the side-to-side difference (SSD, in millimeters) in anterior tibial translation between the injured and contralateral uninjured knee using the KT-2000 arthrometer under a 30-lb (134 N) anterior load at 30 degrees of knee flexion.
Rotational Knee Stability Evaluated by Pivot-Shift Test
Time frame: Up to 24 months postoperatively (assessed at preoperative baseline, 3, 6, 12, and 24 months after surgery)
Rotational knee stability evaluated by the manual pivot-shift test and graded according to International Knee Documentation Committee (IKDC) guidelines: Grade 0 (normal/equal), Grade 1 (glide), Grade 2 (clunk), Grade 3 (gross).
6 secondary outcomes
Graft Signal-to-Noise Quotient (SNQ) on Postoperative MRI
Time frame: 12 months after surgery
Structural Integrity and Graft Continuity on Postoperative MRI
Time frame: 12 months after surgery
Knee Pain Assessed by Visual Analog Scale (VAS)
Time frame: Preoperative baseline, and 6, 12, and 24 months after surgery
International Knee Documentation Committee (IKDC) Subjective Knee Score
Time frame: Preoperative baseline, and 6, 12, and 24 months after surgery
Lysholm Knee Scoring Scale
Time frame: Preoperative baseline, and 6, 12, and 24 months after surgery
Tegner Activity Scale
Time frame: Preoperative baseline, and 6, 12, and 24 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 38435259Bi AS, Hughes AJ, Savage-Elliott I, Lowe D, Meislin RJ. Anterior Cruciate Ligament Allograft Reconstruction Augmented With a Reinforced, Bioinductive Collagen Scaffold in the Setting of Multiligamentous Knee Injury. Arthrosc Tech. 2024 Jan 1;13(2):102865. doi: 10.1016/j.eats.2023.09.034. eCollection 2024 Feb.
- Background: PubMed 38196875Pyrz K, Wood A, Campbell C, Brabston E, Evely T, Casp A, Momaya A. Anterior Cruciate Ligament Reconstruction With Quadriceps Tendon Autograft: Surgical Technique Using Augmentation With a Biocomposite Scaffold. Arthrosc Tech. 2023 Nov 27;12(12):e2335-e2341. doi: 10.1016/j.eats.2023.08.003. eCollection 2023 Dec.
- Background: PubMed 38584643Marks Benson E, Pyrz K, Wood A, Momaya A, Brabston E, Evely T, Casp A. Anterior Cruciate Ligament Reconstruction using Bone-Tendon-Bone Allograft: Surgical Technique Using Augmentation with Bio-Composite Scaffold. Arthrosc Tech. 2024 Jan 1;13(3):102877. doi: 10.1016/j.eats.2023.11.005. eCollection 2024 Mar.
- Individual participant dataSharing planned: Undecided. The plan to share individual participant data with other researchers has not yet been determined.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing BioBrace® Reinforced BioInductive Implant in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, run by Yonsei University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sung-Hwan Kim, M.D., Ph.D. (+82-2-2228-2180, orthohwan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side-to-Side Difference in Anterior Knee Laxity Measured by KT-2000 Arthrometer (time frame: Up to 24 months postoperatively (assessed at preoperative baseline, 3, 6, 12, and 24 months after surgery)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07906860, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.