Anterior Cruciate Ligament InjuriesNCT05398341
A Prospective Cohort Post Market Registry Evaluating Outcomes of Bridge-Enhanced ACL Restoration (BEAR®)
An observational study of Anterior Cruciate Ligament Injuries, run by Miach Orthopaedics at 8 sites in United States.
Trial summary
The purpose of the Bridge Registry is to assess real-world performance of the FDA approved BEAR Implant. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- The BEAR® Implant
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 8 sitesUnited States
- Study dates
- 28 Feb 2023to 30 Jan 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The registry will enroll consecutive subjects who meet the inclusion criteria with an expected sample size of up to 750 subjects.
Who may be able to join
- Scheduled to undergo ACL surgery with the BEAR Implant
- Willing and able to provide informed consent
- Willing and able to complete required follow-up visits and assessments
- 1. Underwent ACL surgery with the BEAR Implant
Who cannot join
- The subject is participating in another ACL trial or any other clinical trial where the study procedure or treatment might confound the study end point
- Known allergy to bovine collagen, bovine gelatin or other bovine-derived products as contraindicated in the BEAR Implant labeling
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Duke University
Durham, North Carolina, 27705
Virtua Health
Marlton, New Jersey, 08053
Hospital for Special Surgery
New York, New York, 10021
Advent Health
Orlando, Florida, 32804
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
Stanford
Redwood City, California, 94063
Victory Sports Medicine
Skaneateles, New York, 13152
Steamboat Orthopaedic and Spine Institute
Steamboat Springs, Colorado, 80487
About this study
The purpose of the Bridge Registry is to assess real-world performance of the FDA approved BEAR Implant.
Read the detailed description
This is an observational study, where the BEAR Implant will be evaluated in a real-world setting. The registry seeks to enroll consecutive uses of the BEAR Implant at participating sites. There will be a prospective cohort for all subjects scheduled to undergo ACL surgery with the BEAR Implant that are willing to provide consent. A retrospective cohort will be available for all subjects treated with a BEAR Implant at each participating site. There is no control group.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- The BEAR® Implant
- Keywords
- ACL, ACL surgery, ACL tear, Torn ACL, BEAR Implant, BEAR ACL, BEAR restoration, Bridge-enhanced ACL restoration, ACL restoration, ACL implant bridge
- 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.
The BEAR® ImplantDevice
The BEAR Implant is a bovine collagen-based implant. The bovine tissue is sourced from countries that are free of bovine spongiform encephalopathy [BSE] and is further treated to remove bovine cell fragments and DNA.
The BEAR® (Bridge Enhanced ACL Restoration) Implant is a bovine extracellular matrix collagen-based implant for treatment of anterior cruciate ligament (ACL) injuries. The BEAR® Implant is indicated for skeletally mature subjects at least 14 years of age with a complete rupture of the ACL. Subjects must have an ACL stump attached to the tibia to construct the repair.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Cohort | There will be a prospective cohort for all subjects scheduled to undergo ACL surgery with the BEAR Implant that are willing to provide consent. Receives: Device: The BEAR® Implant | |
| Retrospective Cohort | A retrospective cohort will be available for all subjects treated with the BEAR Implant at each participating site. There is no control group. Receives: Device: The BEAR® Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation score at year 2
This is a survey patients complete about how their knee is feeling and functioning. Range is 0 to 100, with 100 indicating no problems and 0 indicating extreme problems.
Measured: 2 Years
Knee laxity based on the Lachman test at 1 year
The Lachman will be performed during physical exam.
Measured: 1 year
Secondary outcomes (7)
IKDC Subjective Knee Evaluation Score and Physical Exam at 6, 9 and 12 months post-surgery and according to standard of care
This is an examination performed of the knee. Scores are one of four measures: A (Normal), B (Nearly Normal), C (Abnormal) and D (Severely Abnormal). A is the best outcome and D is the worst.
Measured: 6-12 months
Knee Injury and Osteoarthritis Outcome Score (KOOS) domains: Symptoms/Stiffness, Pain, Knee Related Quality of Life, and Knee Related Sports/Recreational Activities starting at 6, 9, 12 months and at 2 years after surgery
This is a survey with 5 subscales (Pain, Symptoms, Function in Daily Living, Function in Sport and Recreation, and Knee Related Quality of Life). The range of each subscale is 0 to 100, with 100 indicating no problems and 0 indicating extreme problems. The subscales are reported individually and not combined.
Measured: 6 months- 2 years post surgery
Marx Activity Score at 6, 9, 12 months and at 2 years after surgery
Patients are asked to indicate approximately how many times in the past 12 months they performed each of these activities while at their healthiest and most active state. The four knee functions are rated on a 5-point scale of frequency and scores are added up to a maximum of 16 points with a higher score indicating more frequent participation.
Measured: 6 months thru 2 years
Return to Sports Index (RSI) at 6, 9, 12 months and at 2 years after surgery
Measures the patients emotion, confidence, and risk appraisal when returning to sports after an ACL injury and/or reconstructive surgery. There are 12 questions and the subjects answer each in range is from 0 to 100. The response scale meaning is dictated by the question. The sum of all questions are reported, divided by 12,000 and multiplied by 100 to get a %.
Measured: 6 months thru 2 years
VAS (Visual Analog Scale) Pain Score from post op through the first 12 months (approximately every 12 weeks) and at 2 years after surgery
A tool widely used to measure pain. The patient indicates his/her perceived pain intensity along a 100 mm horizontal line and this rate is then measure from the left edge to give a score.
Measured: 1 year
Current Status Questionnaire
Elements include return to activity, pain medication use. No Score.
Measured: 2 years
Pain Medication Use
Administered by questionnaire. No score.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start28 Feb 2023
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miach Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398341
- Sponsor's protocol ID
- Bridge Registry
- Status last verified
- Jun 2026
- First submitted
- 26 May 2022
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Post Market Registry Evaluating Outcomes of Bridge-Enhanced ACL Restoration (BEAR®)
- ClinicalTrials.gov ID
- NCT05398341
- Acronym / sponsor ID
- Bridge Registry
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- ACL, ACL surgery, ACL tear, Torn ACL, BEAR Implant, BEAR ACL, BEAR restoration, Bridge-enhanced ACL restoration
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Miach OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 31 May 2022 (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.
The purpose of the Bridge Registry is to assess real-world performance of the FDA approved BEAR Implant.
Detailed description
This is an observational study, where the BEAR Implant will be evaluated in a real-world setting. The registry seeks to enroll consecutive uses of the BEAR Implant at participating sites. There will be a prospective cohort for all subjects scheduled to undergo ACL surgery with the BEAR Implant that are willing to provide consent. A retrospective cohort will be available for all subjects treated with a BEAR Implant at each participating site. There is no control group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort | – | Device: The BEAR® ImplantThere will be a prospective cohort for all subjects scheduled to undergo ACL surgery with the BEAR Implant that are willing to provide consent. |
| Retrospective Cohort | – | Device: The BEAR® ImplantA retrospective cohort will be available for all subjects treated with the BEAR Implant at each participating site. There is no control group. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The registry will enroll consecutive subjects who meet the inclusion criteria with an expected sample size of up to 750 subjects.
Key inclusion criteria (4 listed)
- Scheduled to undergo ACL surgery with the BEAR Implant
- Willing and able to provide informed consent
- Willing and able to complete required follow-up visits and assessments
- 1. Underwent ACL surgery with the BEAR Implant
Key exclusion criteria (2 listed)
- The subject is participating in another ACL trial or any other clinical trial where the study procedure or treatment might confound the study end point
- Known allergy to bovine collagen, bovine gelatin or other bovine-derived products as contraindicated in the BEAR Implant labeling
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 |
|---|---|---|
| The BEAR® ImplantThe BEAR Implant is a bovine collagen-based implant. The bovine tissue is sourced from countries that are free of bovine spongiform encephalopathy [BSE] and is further treated to remove bovine cell fragments and DNA. The BEAR® (Bridge Enhanced ACL Restoration) Implant is a bovine extracellular matrix collagen-based implant for treatment of anterior cruciate ligament (ACL) injuries. The BEAR® Implant is indicated for skeletally mature subjects at least 14 years of age with a complete rupture of the ACL. Subjects must have an ACL stump attached to the tibia to construct the repair. | Device | Prospective Cohort, Retrospective Cohort |
Primary outcome
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation score at year 2
Time frame: 2 Years
This is a survey patients complete about how their knee is feeling and functioning. Range is 0 to 100, with 100 indicating no problems and 0 indicating extreme problems.
Knee laxity based on the Lachman test at 1 year
Time frame: 1 year
The Lachman will be performed during physical exam.
7 secondary outcomes
IKDC Subjective Knee Evaluation Score and Physical Exam at 6, 9 and 12 months post-surgery and according to standard of care
Time frame: 6-12 months
Knee Injury and Osteoarthritis Outcome Score (KOOS) domains: Symptoms/Stiffness, Pain, Knee Related Quality of Life, and Knee Related Sports/Recreational Activities starting at 6, 9, 12 months and at 2 years after surgery
Time frame: 6 months- 2 years post surgery
Marx Activity Score at 6, 9, 12 months and at 2 years after surgery
Time frame: 6 months thru 2 years
Return to Sports Index (RSI) at 6, 9, 12 months and at 2 years after surgery
Time frame: 6 months thru 2 years
VAS (Visual Analog Scale) Pain Score from post op through the first 12 months (approximately every 12 weeks) and at 2 years after surgery
Time frame: 1 year
Current Status Questionnaire
Time frame: 2 years
Pain Medication Use
Time frame: 2 years
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 9 Jun 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Injuries, run by Miach Orthopaedics at 8 sites 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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation score at year 2 (time frame: 2 Years). 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 9 Jun 2026.