ACL TearsNCT06948591
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
An observational study of ACL Tears, run by CONMED Corporation at 1 site in United States.
Trial summary
This research study will evaluate mid-term clinical safety and performance outcomes of the BioBrace® Reinforced Implant when used to augment a tissue graft during anterior cruciate ligament (ACL) reconstruction. Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- ACL Tears
- What is being tested?
- Anterior cruciate ligament reconstruction with BioBrace® augmentation and Arthroscopic anterior cruciate ligament reconstruction
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2025to Jun 2030
- Phase
- Observational
- 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 14 to 70 years
- All sexes
- Child, Adult, Older adult
Study population: Community surrounding participating hospitals / clinics.
Who may be able to join
- Underwent ACL reconstruction with a tissue graft augmented with BioBrace® within the past 24 months from study start date or scheduled to undergo ACL reconstruction with a tissue graft augmented with BioBrace®.
- Between 14 and 70 years old at the time of surgery.
- Can understand the content of the subject information / Informed Consent Form (ICF) for the prospective portion of the study.
- Is willing and able to participate in the prospective data collection protocol and comply with the required data collection.
- If the subject has already undergone ACLR within the past 24 months, subject must have at least two (2) of the following measures at baseline and 1 year post-operatively:
- International Knee Documentation Committee (IKDC)
Show all 11Show fewer
- Knee Injury and Osteoarthritis Outcome Score Junior (KOOS, JR.)
- Patient-Reported Outcomes Measurement Information System (PROMIS-10)
- Tegner Activity Scale (TAS)
- Anterior Cruciate Ligament - Return to Sport After Injury (ACL-RSI)
- Positive diagnostic imaging by MRI at baseline indicating an ACL tear
Who cannot join
- Has other concurrent medical or other conditions (chronic or acute in nature) that in the opinion of the participating investigator may prevent participation or otherwise render subject ineligible for the study.
- Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 3 years following enrollment into the study.
- Underwent or scheduled to undergo a multi-ligament reconstruction procedure (excluding cases where a torn MCL is treated non-operatively).
- Females of child-bearing potential who are either pregnant or breastfeeding at the time of surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
ConMed
New Haven, Connecticut, 06513
ClinicalAffairs@conmed.com
About this study
Official title: Real World Evaluation of the Safety and Effectiveness of BioBrace® Augmentation in Anterior Cruciate Ligament (ACL) Reconstruction Procedures
This research study will evaluate mid-term clinical safety and performance outcomes of the BioBrace® Reinforced Implant when used to augment a tissue graft during anterior cruciate ligament (ACL) reconstruction.
Read the detailed description
This is a multi-center, single arm, open label registry investigating anterior cruciate ligament reconstruction (ACLR) procedures where the tissue graft is augmented with BioBrace®. Subjects meeting the inclusion/exclusion criteria will be enrolled retrospectively or prospectively. Clinical evaluations will be conducted at baseline (pre-operatively) and at 6 months, 1-, 2-, and 3-years post-operatively using various patient-reported outcome measures to assess pain, function, return to activity, and safety post-surgery.
- Conditions
- ACL Tears
- Being tested
- Anterior cruciate ligament reconstruction with BioBrace® augmentation, Arthroscopic anterior cruciate ligament reconstruction
- Keywords
- ACL reconstruction, BioBrace, augmentation
- 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.
Anterior cruciate ligament reconstruction with BioBrace® augmentationDevice
An arthroscopic anterior cruciate ligament reconstruction (ACLR) will be performed and the tissue graft will be augmented with the BioBrace® Reinforced Implant. BioBrace® is intended for use in surgical procedures for reinforcement of soft tissue where weakness exists. It is a bioresorbable, biocomposite scaffold composed of a highly porous collagen sponge and reinforced with poly-L-lactic-acid (PLLA). When used in ACLRs, it is sutured alongside the tissue graft to augment and reinforce the graft construct. BioBrace® is designed to mechanically and biologically augment weakened or torn soft tissue and can be integrated into surgeons' standard of care ACL reconstruction techniques.
Arthroscopic anterior cruciate ligament reconstructionProcedure or surgery
An arthroscopic anterior cruciate ligament reconstruction is performed using standard surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| BioBrace Augment Group | An anterior cruciate ligament reconstruction is performed and BioBrace is used to augment the tissue graft. Receives: Device: Anterior cruciate ligament reconstruction with BioBrace® augmentation; Procedure: Arthroscopic anterior cruciate ligament reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Function
Improvement in function measured with International Knee Documentation Committee (IKDC) from baseline to 3 years post-surgery.
Measured: 3 years post-op
Adverse Events
Evaluation of device-related adverse events
Measured: Baseline, 6-months, 1-, 2-, and 3-years post-op
Secondary outcomes (7)
International Knee Documentation Committee (IKDC)
Patient-reported functional and activity status as assessed by International Knee Documentation Committee (IKDC)
Measured: Baseline, 6 months, 1-, 2-years post-op
Knee Injury and Osteoarthritis Outcome Score Junior (KOOS, JR.)
Patient-reported functional and activity status as assessed by the following: Knee Injury and Osteoarthritis Outcome Score Junior (KOOS, JR.)
Measured: Baseline, 6 months, 1-, 2-, and 3-years post-op
Patient-Reported Outcomes Measurement Information System (PROMIS-10)
Patient-reported functional and activity status as assessed by the following: Patient-Reported Outcomes Measurement Information System (PROMIS-10)
Measured: Baseline, 6 months, 1-, 2-, and 3-years post-op
Tegner Activity Scale (TAS)
Patient-reported functional and activity status as assessed by: Tegner Activity Scale (TAS).
Measured: Baseline, 6 months, 1-, 2-, and 3-years post-op
Anterior Cruciate Ligament - Return to Sport After Injury (ACL-RSI)
Patient-reported functional and activity status as assessed by the following: Anterior Cruciate Ligament - Return to Sport After Injury (ACL-RSI)
Measured: 6 months, 1-, 2-, and 3-years post-op
Secondary Surgical Intervention(s)
The percentage of subjects who required additional surgical procedures following discharge from the BioBrace ACLR index procedure will be reported.
Measured: 6 months, 1-, 2-, and 3-years post-op
Re-tear Rate
Re-tear rate of the surgically reconstructed ACL tissue graft augmented with BioBrace. The percentage of subjects who experienced a re-tear of the augmented ACL tissue graft will be reported.
Measured: 6 months, 1-, 2-, and 3-years post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start8 Apr 2025
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL TearsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CONMED Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948591
- Sponsor's protocol ID
- CSP-BB0004
- Status last verified
- Oct 2026
- First submitted
- 18 Apr 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Evaluation of the Safety and Effectiveness of BioBrace® Augmentation in Anterior Cruciate Ligament (ACL) Reconstruction Procedures
- ClinicalTrials.gov ID
- NCT06948591
- Acronym / sponsor ID
- CSP-BB0004
- Conditions
- ACL Tears
- Keywords
- ACL reconstruction, BioBrace, augmentation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- CONMED CorporationIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 29 Apr 2025 (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 research study will evaluate mid-term clinical safety and performance outcomes of the BioBrace® Reinforced Implant when used to augment a tissue graft during anterior cruciate ligament (ACL) reconstruction.
Detailed description
This is a multi-center, single arm, open label registry investigating anterior cruciate ligament reconstruction (ACLR) procedures where the tissue graft is augmented with BioBrace®. Subjects meeting the inclusion/exclusion criteria will be enrolled retrospectively or prospectively. Clinical evaluations will be conducted at baseline (pre-operatively) and at 6 months, 1-, 2-, and 3-years post-operatively using various patient-reported outcome measures to assess pain, function, return to activity, and safety post-surgery.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BioBrace Augment Group | – | Device: Anterior cruciate ligament reconstruction with BioBrace® augmentation, Procedure: Arthroscopic anterior cruciate ligament reconstructionAn anterior cruciate ligament reconstruction is performed and BioBrace is used to augment the tissue graft. |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Community surrounding participating hospitals / clinics.
Key inclusion criteria (11 listed)
- Underwent ACL reconstruction with a tissue graft augmented with BioBrace® within the past 24 months from study start date or scheduled to undergo ACL reconstruction with a tissue graft augmented with BioBrace®.
- Between 14 and 70 years old at the time of surgery.
- Can understand the content of the subject information / Informed Consent Form (ICF) for the prospective portion of the study.
- Is willing and able to participate in the prospective data collection protocol and comply with the required data collection.
- If the subject has already undergone ACLR within the past 24 months, subject must have at least two (2) of the following measures at baseline and 1 year post-operatively:
Key exclusion criteria (4 listed)
- Has other concurrent medical or other conditions (chronic or acute in nature) that in the opinion of the participating investigator may prevent participation or otherwise render subject ineligible for the study.
- Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 3 years following enrollment into the study.
- Underwent or scheduled to undergo a multi-ligament reconstruction procedure (excluding cases where a torn MCL is treated non-operatively).
- Females of child-bearing potential who are either pregnant or breastfeeding at the time of surgery.
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 |
|---|---|---|
| Anterior cruciate ligament reconstruction with BioBrace® augmentationAn arthroscopic anterior cruciate ligament reconstruction (ACLR) will be performed and the tissue graft will be augmented with the BioBrace® Reinforced Implant. BioBrace® is intended for use in surgical procedures for reinforcement of soft tissue where weakness exists. It is a bioresorbable, biocomposite scaffold composed of a highly porous collagen sponge and reinforced with poly-L-lactic-acid (PLLA). When used in ACLRs, it is sutured alongside the tissue graft to augment and reinforce the graft construct. BioBrace® is designed to mechanically and biologically augment weakened or torn soft tissue and can be integrated into surgeons' standard of care ACL reconstruction techniques. | Device | BioBrace Augment Group |
| Arthroscopic anterior cruciate ligament reconstructionAn arthroscopic anterior cruciate ligament reconstruction is performed using standard surgical procedure. | Procedure or surgery | BioBrace Augment Group |
Primary outcome
Improvement in Function
Time frame: 3 years post-op
Improvement in function measured with International Knee Documentation Committee (IKDC) from baseline to 3 years post-surgery.
Adverse Events
Time frame: Baseline, 6-months, 1-, 2-, and 3-years post-op
Evaluation of device-related adverse events
7 secondary outcomes
International Knee Documentation Committee (IKDC)
Time frame: Baseline, 6 months, 1-, 2-years post-op
Knee Injury and Osteoarthritis Outcome Score Junior (KOOS, JR.)
Time frame: Baseline, 6 months, 1-, 2-, and 3-years post-op
Patient-Reported Outcomes Measurement Information System (PROMIS-10)
Time frame: Baseline, 6 months, 1-, 2-, and 3-years post-op
Tegner Activity Scale (TAS)
Time frame: Baseline, 6 months, 1-, 2-, and 3-years post-op
Anterior Cruciate Ligament - Return to Sport After Injury (ACL-RSI)
Time frame: 6 months, 1-, 2-, and 3-years post-op
Secondary Surgical Intervention(s)
Time frame: 6 months, 1-, 2-, and 3-years post-op
Re-tear Rate
Time frame: 6 months, 1-, 2-, and 3-years post-op
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 23 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ACL Tears, run by CONMED Corporation at 1 site in United States.
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 11 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Kelley Grynewicz (7274574955, ClinicalAffairs@conmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Function (time frame: 3 years post-op). 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?
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 23 Oct 2026.