Anterior Cruciate Ligament TearNCT02664545

Bridge-Enhanced ACL Repair vs ACL Reconstruction

A study testing BEAR Scaffold and Tendon Graft in people with Anterior Cruciate Ligament Tear, run by Miach Orthopaedics at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The goal of this trial is to compare the efficacy of the Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR™) technique with the current method of treatment for anterior cruciate ligament (ACL) injuries, ACL reconstruction. Read more about this study

Who is it for?: Ages 14 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Anterior Cruciate Ligament Tear
What is being tested?: BEAR Scaffold and Tendon Graft
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: Apr 2016to 31 May 2028
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 35 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Age: 14 to 35 years of age.
Sex: Both male and female
ACL: Complete tear
Time from injury to surgery: ≤45 days
MRI: ACL tissue present on pre-operative MRI - at least 50% of the ACL length must still be attached to the tibial plateau

Who cannot join

Prior surgery on affected knee
Prior joint infection on affected knee
Regular use of tobacco or nicotine
Use of corticosteroid within last 3 months
History of chemotherapy treatment
History of sickle cell disease

Show all 12Show fewer

History of anaphylaxis
Any condition that could affect healing or infection risk (Diabetes, inflammatory arthritis, etc)
Operative posterolateral corner injury (LCL complete tear, Biceps femoris tendon avulsion, tear of the arcuate ligament, tear of the popliteus ligament)
Grade III medial collateral ligament injury
Complete patellar dislocation
Known allergy to bovine, beef or cow products

Trial locations and contacts

1 site in 1 country.

United States1 site

Boston Children's Hospital
Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: A Prospective, Randomized, Controlled, Clinical Trial Evaluating the Non-Inferiority of Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) to Anterior Cruciate Ligament Reconstruction With an Autologous Tendon Graft (ACLR)

Read the detailed description

Enrolled patients will be randomized to either the Bridge-Enhanced ACL Repair (BEAR) technique (new treatment) or an ACL reconstruction (current gold standard of treatment).

Conditions: Anterior Cruciate Ligament Tear
Being tested: BEAR Scaffold, Tendon Graft
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.

BEAR ScaffoldDevice
A sponge, or scaffold, which is surgically placed between the torn ligament ends and sutures are used to repair the torn anterior cruciate ligament.
Tendon GraftProcedure or surgery
A graft of tendon (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee)

Study groups in NCT02664545
Study group	Role	What they receive
Bridge-Enhanced ACL Repair (BEAR)	Experimental	The BEAR technique involves surgically placing a sponge (the BEAR scaffold) between the torn ends of the ACL, providing a scaffold for the ligament ends to grow into. Receives: Device: BEAR Scaffold
Tendon Graft	Active comparator	ACL reconstruction is when a tendon graft (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee) is taken and used to replace the torn ACL. Receives: Procedure: Tendon Graft

What is being measured

The primary outcome is the main question the study is designed to answer.

International Knee Documentation Committee (IKDC) Subjective
This is a survey taken by patients to report how their knee is working for them. The IKDC is graded by adding the results and converting the result to a number on a scale from 0 to 100. Scores range from 0 (lowest level of function and highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Measured: 2 years after surgery
Instrumented Anteroposterior (AP) Laxity Testing
This is a test of how stable the knee is.
The anteroposterior (AP) knee laxity will be determined using a KT arthrometer at the 30lb (130N) setting on both knees of the subject at six months and 1, 2, 6 and 10 years after surgery (see Appendix C). Both sides will be covered with a sleeve so the licensed examiner cannot tell which is the operated knee or which procedure the patient had.
Values for both knees will be recorded. For knee laxity, a difference of 2.0 mm in the side-to-side difference measurements at 2 years after surgery, the primary analysis, for the patients in the bridge-enhanced repair group vs. the ACL reconstruction group will be considered clinically significant.
Measured: 2 years after surgery

Secondary outcomes (2)

Prone Hamstring Strength at 6 Months
Measured by a hand-held dynamometer on both the involved and contralateral knees, measured as injured knee as percent of non injured knee. The subject lies on their stomach and flexes their leg. The trainer puts the dynamometer near the ankle in the direction of extension. The subject pushes as hard as they can in the flexion direction, against the dynamometer. Ratio is calculated as the measurement of injured knee over measurement of non-injured knee.
Measured: 6 months
Return to Sport (RSI) Patient Reported Outcomes Score at 6 Months.
This is a survey taken by patients to report how confident they are in returning to sports after the injury. The 12 questions on the ACL-RSI scale ask about the psychological effects of returning to sports. The ACL-RSI items are graded using an NRS (numeric rating scale) from 0 to 10. It has three domains: risk appraisal, confidence, and emotions. A total score between 0 and 100 is calculated by adding and averaging the scores for each item. Greater psychological preparation is indicated by higher scores.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 201631 May 2028

First posted27 Jan 2016 (estimated)
Study startApr 2016
Primary completion19 Jun 2019
Study completion31 May 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Anterior Cruciate Ligament TearStudies 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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02664545
Sponsor's protocol ID: BEAR II TRIAL
Status last verified: Dec 2025
First submitted: 20 Jan 2016
Last updated: 30 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated device: Yes
Individual data sharing: No

Publications

Pruneski JA, Kaushal SG, Ecklund K, Kramer DE, Yen YM, Micheli LJ, Fleming BC, Murray MM, Kiapour AM. Magnetic Resonance Imaging Assessment of Bridge-Enhanced ACL Restoration: An Imaging Atlas of Morphological Features and Healing Trajectories. Orthop J Sports Med. 2026 Jun 10;14(6):23259671261445974. doi: 10.1177/23259671261445974. eCollection 2026 Jun.
PubMed 42293045
Menghini D, Kaushal SG, Flannery SW, Ecklund K; BEAR Trial Team; Murray MM, Fleming BC, Kiapour AM, Proffen B, Sant N, Portilla G, Sanborn R, Freiberger C, Henderson R, Barnett S, Yen YM, Kramer DE, Micheli LJ. Changes in the Cross-Sectional Profile of Treated Anterior Cruciate Ligament Within 2 Years After Surgery. Orthop J Sports Med. 2022 Oct 14;10(10):23259671221127326. doi: 10.1177/23259671221127326. eCollection 2022 Oct.
PubMed 36263311
Sanborn RM, Badger GJ; BEAR Trial Team; Yen YM, Murray MM, Christino MA, Proffen B, Sant N, Barnett S, Fleming BC, Kramer DE, Micheli LJ. Psychological Readiness to Return to Sport at 6 Months Is Higher After Bridge-Enhanced ACL Restoration Than Autograft ACL Reconstruction: Results of a Prospective Randomized Clinical Trial. Orthop J Sports Med. 2022 Feb 9;10(2):23259671211070542. doi: 10.1177/23259671211070542. eCollection 2022 Feb.
PubMed 35155707
Barnett SC, Murray MM, Flannery SW; BEAR Trial Team; Menghini D, Fleming BC, Kiapour AM, Proffen B, Sant N, Portilla G, Sanborn R, Freiberger C, Henderson R, Ecklund K, Yen YM, Kramer D, Micheli L. ACL Size, but Not Signal Intensity, Is Influenced by Sex, Body Size, and Knee Anatomy. Orthop J Sports Med. 2021 Dec 17;9(12):23259671211063836. doi: 10.1177/23259671211063836. eCollection 2021 Dec.
PubMed 34988237
Barnett SC, Murray MM, Badger GJ; BEAR Trial Team; Yen YM, Kramer DE, Sanborn R, Kiapour A, Proffen B, Sant N, Fleming BC, Micheli LJ. Earlier Resolution of Symptoms and Return of Function After Bridge-Enhanced Anterior Cruciate Ligament Repair As Compared With Anterior Cruciate Ligament Reconstruction. Orthop J Sports Med. 2021 Nov 9;9(11):23259671211052530. doi: 10.1177/23259671211052530. eCollection 2021 Nov.
PubMed 34778483
Murray MM, Fleming BC, Badger GJ; BEAR Trial Team; Freiberger C, Henderson R, Barnett S, Kiapour A, Ecklund K, Proffen B, Sant N, Kramer DE, Micheli LJ, Yen YM. Bridge-Enhanced Anterior Cruciate Ligament Repair Is Not Inferior to Autograft Anterior Cruciate Ligament Reconstruction at 2 Years: Results of a Prospective Randomized Clinical Trial. Am J Sports Med. 2020 May;48(6):1305-1315. doi: 10.1177/0363546520913532. Epub 2020 Apr 16.
PubMed 32298131
Murray MM, Kiapour AM, Kalish LA, Ecklund K; BEAR Trial Team; Freiberger C, Henderson R, Kramer D, Micheli L, Yen YM, Fleming BC. Predictors of Healing Ligament Size and Magnetic Resonance Signal Intensity at 6 Months After Bridge-Enhanced Anterior Cruciate Ligament Repair. Am J Sports Med. 2019 May;47(6):1361-1369. doi: 10.1177/0363546519836087. Epub 2019 Apr 15.
PubMed 30986359

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Anterior Cruciate Ligament Tear trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Controlled, Clinical Trial Evaluating the Non-Inferiority of Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) to Anterior Cruciate Ligament Reconstruction With an Autologous Tendon Graft (ACLR)
ClinicalTrials.gov ID: NCT02664545
Acronym / sponsor ID: BEAR II TRIAL
Conditions: Anterior Cruciate Ligament Tear
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 100 participants (actual)
Lead sponsor: Miach OrthopaedicsIndustry (pharma, biotech, devices)
Study start: Apr 2016 (actual)
Primary completion: 19 Jun 2019 (actual)
Study completion: 31 May 2028 (estimated)
First posted: 27 Jan 2016 (estimated)
Results: Posted 10 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Enrolled patients will be randomized to either the Bridge-Enhanced ACL Repair (BEAR) technique (new treatment) or an ACL reconstruction (current gold standard of treatment).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Bridge-Enhanced ACL Repair (BEAR)	Experimental	Device: BEAR ScaffoldThe BEAR technique involves surgically placing a sponge (the BEAR scaffold) between the torn ends of the ACL, providing a scaffold for the ligament ends to grow into.
Tendon Graft	Active comparator	Procedure: Tendon GraftACL reconstruction is when a tendon graft (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee) is taken and used to replace the torn ACL.

Who may qualify

Ages: 14 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

Age: 14 to 35 years of age.
Sex: Both male and female
ACL: Complete tear
Time from injury to surgery: ≤45 days
MRI: ACL tissue present on pre-operative MRI - at least 50% of the ACL length must still be attached to the tibial plateau

Key exclusion criteria (12 listed)

Prior surgery on affected knee
Prior joint infection on affected knee
Regular use of tobacco or nicotine
Use of corticosteroid within last 3 months
History of chemotherapy treatment

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
BEAR ScaffoldA sponge, or scaffold, which is surgically placed between the torn ligament ends and sutures are used to repair the torn anterior cruciate ligament.	Device	Bridge-Enhanced ACL Repair (BEAR)
Tendon GraftA graft of tendon (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee)	Procedure or surgery	Tendon Graft

Primary outcome

International Knee Documentation Committee (IKDC) Subjective
Time frame: 2 years after surgery
This is a survey taken by patients to report how their knee is working for them. The IKDC is graded by adding the results and converting the result to a number on a scale from 0 to 100. Scores range from 0 (lowest level of function and highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Instrumented Anteroposterior (AP) Laxity Testing
Time frame: 2 years after surgery
This is a test of how stable the knee is. The anteroposterior (AP) knee laxity will be determined using a KT arthrometer at the 30lb (130N) setting on both knees of the subject at six months and 1, 2, 6 and 10 years after surgery (see Appendix C). Both sides will be covered with a sleeve so the licensed examiner cannot tell which is the operated knee or which procedure the patient had. Values for both knees will be recorded. For knee laxity, a difference of 2.0 mm in the side-to-side difference measurements at 2 years after surgery, the primary analysis, for the patients in the bridge-enhanced repair group vs. the ACL reconstruction group will be considered clinically significant.

2 secondary outcomes

Prone Hamstring Strength at 6 Months
Time frame: 6 months
Return to Sport (RSI) Patient Reported Outcomes Score at 6 Months.
Time frame: 6 months

Results and safety

Results posted to the registry on 10 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bridge-Enhanced ACL Repair (BEAR)	65	58
Tendon Graft	35	32

Primary outcome: International Knee Documentation Committee (IKDC) Subjective

Time frame: 2 years after surgery. Mean (Standard Deviation). Unit: score on a scale

Measure	Bridge-Enhanced ACL Repair (BEAR) n = 65	Tendon Graft n = 35
Value	88.6 (13.4)	84.6 (13.3)

Population analysed: Multiple imputation used for missing data.

Primary outcome: Instrumented Anteroposterior (AP) Laxity Testing

Time frame: 2 years after surgery. Mean (Standard Deviation). Unit: mm

Measure	Bridge-Enhanced ACL Repair (BEAR) n = 65	Tendon Graft n = 35
Value	1.7 (3.2)	1.8 (2.8)

Population analysed: Multiple imputation used for missing data.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events measured at 2-year Primary Endpoint.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bridge-Enhanced ACL Repair (BEAR)	16 of 65 (24.6%)	34 of 65 (52.3%)	0 of 65
Tendon Graft	5 of 35 (14.3%)	11 of 35 (31.4%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42293045Pruneski JA, Kaushal SG, Ecklund K, Kramer DE, Yen YM, Micheli LJ, Fleming BC, Murray MM, Kiapour AM. Magnetic Resonance Imaging Assessment of Bridge-Enhanced ACL Restoration: An Imaging Atlas of Morphological Features and Healing Trajectories. Orthop J Sports Med. 2026 Jun 10;14(6):23259671261445974. doi: 10.1177/23259671261445974. eCollection 2026 Jun.
Derived from this study: PubMed 36263311Menghini D, Kaushal SG, Flannery SW, Ecklund K; BEAR Trial Team; Murray MM, Fleming BC, Kiapour AM, Proffen B, Sant N, Portilla G, Sanborn R, Freiberger C, Henderson R, Barnett S, Yen YM, Kramer DE, Micheli LJ. Changes in the Cross-Sectional Profile of Treated Anterior Cruciate Ligament Within 2 Years After Surgery. Orthop J Sports Med. 2022 Oct 14;10(10):23259671221127326. doi: 10.1177/23259671221127326. eCollection 2022 Oct.
Derived from this study: PubMed 35155707Sanborn RM, Badger GJ; BEAR Trial Team; Yen YM, Murray MM, Christino MA, Proffen B, Sant N, Barnett S, Fleming BC, Kramer DE, Micheli LJ. Psychological Readiness to Return to Sport at 6 Months Is Higher After Bridge-Enhanced ACL Restoration Than Autograft ACL Reconstruction: Results of a Prospective Randomized Clinical Trial. Orthop J Sports Med. 2022 Feb 9;10(2):23259671211070542. doi: 10.1177/23259671211070542. eCollection 2022 Feb.
Derived from this study: PubMed 34988237Barnett SC, Murray MM, Flannery SW; BEAR Trial Team; Menghini D, Fleming BC, Kiapour AM, Proffen B, Sant N, Portilla G, Sanborn R, Freiberger C, Henderson R, Ecklund K, Yen YM, Kramer D, Micheli L. ACL Size, but Not Signal Intensity, Is Influenced by Sex, Body Size, and Knee Anatomy. Orthop J Sports Med. 2021 Dec 17;9(12):23259671211063836. doi: 10.1177/23259671211063836. eCollection 2021 Dec.
Derived from this study: PubMed 34778483Barnett SC, Murray MM, Badger GJ; BEAR Trial Team; Yen YM, Kramer DE, Sanborn R, Kiapour A, Proffen B, Sant N, Fleming BC, Micheli LJ. Earlier Resolution of Symptoms and Return of Function After Bridge-Enhanced Anterior Cruciate Ligament Repair As Compared With Anterior Cruciate Ligament Reconstruction. Orthop J Sports Med. 2021 Nov 9;9(11):23259671211052530. doi: 10.1177/23259671211052530. eCollection 2021 Nov.
Derived from this study: PubMed 32298131Murray MM, Fleming BC, Badger GJ; BEAR Trial Team; Freiberger C, Henderson R, Barnett S, Kiapour A, Ecklund K, Proffen B, Sant N, Kramer DE, Micheli LJ, Yen YM. Bridge-Enhanced Anterior Cruciate Ligament Repair Is Not Inferior to Autograft Anterior Cruciate Ligament Reconstruction at 2 Years: Results of a Prospective Randomized Clinical Trial. Am J Sports Med. 2020 May;48(6):1305-1315. doi: 10.1177/0363546520913532. Epub 2020 Apr 16.
Derived from this study: PubMed 30986359Murray MM, Kiapour AM, Kalish LA, Ecklund K; BEAR Trial Team; Freiberger C, Henderson R, Kramer D, Micheli L, Yen YM, Fleming BC. Predictors of Healing Ligament Size and Magnetic Resonance Signal Intensity at 6 Months After Bridge-Enhanced Anterior Cruciate Ligament Repair. Am J Sports Med. 2019 May;47(6):1361-1369. doi: 10.1177/0363546519836087. Epub 2019 Apr 15.
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.

Yi-Meng Yen, MD principal investigator

Boston Children's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing BEAR Scaffold and Tendon Graft in people with Anterior Cruciate Ligament Tear, run by Miach Orthopaedics 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 5 inclusion and 12 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 30 Dec 2025. 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?

Yes. Results are posted in the registry (first posted 10 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (time frame: 2 years 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 NCT02664545, which also lists 7 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 Dec 2025.