Anterior Cruciate Ligament InjuryNCT03348995
The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration
A study testing Bridge-Enhanced ACL Restoration (BEAR) in people with Anterior Cruciate Ligament Injury and Anterior Cruciate Ligament Rupture, run by Miach Orthopaedics at 11 sites in United States.
Trial summary
Bridge-Enhanced ACL Restoration (BEAR) is a new procedure being developed to treat patients with ACL injuries. In the BEAR procedure, an implant is placed between the torn ends of the ACL and the patient's own blood is added to the implant to stimulate ligament healing. Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Rupture
- What is being tested?
- Bridge-Enhanced ACL Restoration (BEAR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 11 sitesUnited States
- Study dates
- 17 Apr 2018to 17 Apr 2034
- 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 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Inclusion Criteria: ACL tear, within 50 days of injury, at least 5% of the ACL attached to the tibia.
-
Exclusion Criteria: Prior surgery on the affected knee, history of knee infection, use of tobacco, use of corticosteroid, chemotherapy, allergy to bovine products or gelatin, history of anaphylaxis, BMI over 35, moderate osteoarthritis.
-
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Emory University School Of Medicine
Atlanta, Georgia, 30329
Boston Children's Hospital
Boston, Massachusetts, 02115
UT Southwestern
Dallas, Texas, 75390
Inova Sports Medicine
Fairfax, Virginia, 22031
MedStar Health Surgery Center of Timonium
Lutherville, Maryland, 21093
Virtua Health
Marlton, New Jersey, 08053
Ochsner Sports Medicine Institute
New Orleans, Louisiana, 70121
Cynthia Chrostek
Providence, Rhode Island, 02903
Scripps Health
San Diego, California, 92121
Orthopedic Institute of Sioux Falls
Sioux Falls, South Dakota, 57105
Florida Orthopedic Institute
Tampa, Florida, 33637
About this study
Official title: A Prospective Cohort Clinical Trial Evaluating Age as a Risk Factor for Poor Outcomes of Bridge-Enhanced ACL Restoration (BEAR)
Bridge-Enhanced ACL Restoration (BEAR) is a new procedure being developed to treat patients with ACL injuries. In the BEAR procedure, an implant is placed between the torn ends of the ACL and the patient's own blood is added to the implant to stimulate ligament healing. We propose the current study to determine if older patients do better than younger patients (or vice versa) with this procedure. This is a cohort study designed to determine if age is a risk factor for a worse outcome after a bridge-enhanced ACL repair (BEAR) as defined by an 11.5 point difference on the IKDC Subjective or Objective Knee Evaluation score at two years after surgery. Additional objectives are to determine the effect of age on safety outcomes including infection, graft rejection, and need for further surgical procedures.
Read the detailed description
The BEAR III study is a cohort study designed to determine if age is a risk factor for a worse outcome after a bridge-enhanced ACL restoration (BEAR) as defined by an 11.5 point difference on the IKDC Subjective or Objective Knee Evaluation score at two years after surgery. Additional objectives are to determine the effect of age on safety outcomes including infection, graft rejection, and need for further surgical procedures.
- Being tested
- Bridge-Enhanced ACL Restoration (BEAR)
- 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.
Bridge-Enhanced ACL Restoration (BEAR)Device
In the BEAR Procedure, surgery is performed to sew the ACL back together and a scaffold is placed between the torn ends at the time of repair.
| Study group | Role | What they receive |
|---|---|---|
| Bridge-Enhanced ACL Restoration (BEAR) | Experimental | The BEAR technique involves surgically placing an absorbable implant (the BEAR Implant) between the torn ends of the ACL, providing a scaffold for the ligament ends to grow into Receives: Device: Bridge-Enhanced ACL Restoration (BEAR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Knee Documentation Committee Subjective Score (IKDC) (Survey)
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: Time points up to two years
International Knee Documentation Committee Objective Score (IKDC) (Physical Exam)
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: Time points up to two years.
Secondary outcomes (2)
Knee Injury and Osteoarthritis Score (KOOS) questionnaire
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: Time points up to two years
Repair Failure
The number of times patients develop recurrent knee stability and require another ACL surgery.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start17 Apr 2018
- Primary completion28 Feb 2026
- Study completion17 Apr 2034 (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 InjuryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cohort Study
- Masking
- None (open label)
- Enrolment
- 250 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
- NCT03348995
- Sponsor's protocol ID
- BEAR III Trial
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2017
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- 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 Clinical Trial Evaluating Age as a Risk Factor for Poor Outcomes of Bridge-Enhanced ACL Restoration (BEAR)
- ClinicalTrials.gov ID
- NCT03348995
- Acronym / sponsor ID
- BEAR III Trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Miach OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 17 Apr 2034 (estimated)
- First posted
- 21 Nov 2017 (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.
Bridge-Enhanced ACL Restoration (BEAR) is a new procedure being developed to treat patients with ACL injuries. In the BEAR procedure, an implant is placed between the torn ends of the ACL and the patient's own blood is added to the implant to stimulate ligament healing. We propose the current study to determine if older patients do better than younger patients (or vice versa) with this procedure. This is a cohort study designed to determine if age is a risk factor for a worse outcome after a bridge-enhanced ACL repair (BEAR) as defined by an 11.5 point difference on the IKDC Subjective or Objective Knee Evaluation score at two years after surgery. Additional objectives are to determine the effect of age on safety outcomes including infection, graft rejection, and need for further surgical procedures.
Detailed description
The BEAR III study is a cohort study designed to determine if age is a risk factor for a worse outcome after a bridge-enhanced ACL restoration (BEAR) as defined by an 11.5 point difference on the IKDC Subjective or Objective Knee Evaluation score at two years after surgery. Additional objectives are to determine the effect of age on safety outcomes including infection, graft rejection, and need for further surgical procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort Study
| Arm | Type | Receives |
|---|---|---|
| Bridge-Enhanced ACL Restoration (BEAR) | Experimental | Device: Bridge-Enhanced ACL Restoration (BEAR)The BEAR technique involves surgically placing an absorbable implant (the BEAR Implant) between the torn ends of the ACL, providing a scaffold for the ligament ends to grow into |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Bridge-Enhanced ACL Restoration (BEAR)In the BEAR Procedure, surgery is performed to sew the ACL back together and a scaffold is placed between the torn ends at the time of repair. | Device | Bridge-Enhanced ACL Restoration (BEAR) |
Primary outcome
International Knee Documentation Committee Subjective Score (IKDC) (Survey)
Time frame: Time points up to two 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.
International Knee Documentation Committee Objective Score (IKDC) (Physical Exam)
Time frame: Time points up to two years.
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.
2 secondary outcomes
Knee Injury and Osteoarthritis Score (KOOS) questionnaire
Time frame: Time points up to two years
Repair Failure
Time frame: Two 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
Related trials for Anterior Cruciate Ligament Injury
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bridge-Enhanced ACL Restoration (BEAR) in people with Anterior Cruciate Ligament Injury and Anterior Cruciate Ligament Rupture, run by Miach Orthopaedics at 11 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?
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 11 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 Subjective Score (IKDC) (Survey) (time frame: Time points up to two 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.