Bridge-Enhanced ACL Repair-Safety Study (BEAR Trial)
BEAR
1 other identifier
interventional
20
1 country
1
Brief Summary
This study will assess the safety and early efficacy of a newly developed device, bridge-enhanced scaffold (MIACH™,) used to repair a torn anterior cruciate ligament (ACL.) Ten participants will undergo surgery with the new device (Experimental Group) and 10 will undergo a standard ACL reconstruction surgery (Control Group.)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2014
CompletedFirst Posted
Study publicly available on registry
November 17, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedDecember 17, 2025
December 1, 2025
3.2 years
November 12, 2014
December 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and tolerability of the BEAR® Implant
To assess the safety (implant rejection, infection, joint effusion, muscle atrophy, knee laxity) and tolerability of the BEAR® implant
Surgery to 3-months post-op
Secondary Outcomes (5)
Inflammatory reaction
Surgery to 3-months post-op
Muscle Atrophy
At 6-weeks post-op
Excessive Pain
Surgery to 3-months post-op
Implant failure
At 3-months post-op
Anteroposterior (AP) knee laxity
At 6- and 12-months post-op
Study Arms (2)
ACL repair with MIACH scaffold
EXPERIMENTALPatients will undergo ACL repair surgery using the newly developed MIACH scaffold
Standard ACL reconstruction
ACTIVE COMPARATORPatients will undergo a standard ACL reconstruction surgery
Interventions
Surgical insertion of the MIACH scaffold to promote ACL healing/repair
Standard surgical reconstruction of the ACL with autograft hamstring tendon
Eligibility Criteria
You may qualify if:
- Complete ACL tear, confirmed by MRI
- Time from injury to screening must be less than or equal to 90 days
- ACL tissue present on pre-operative MRI
You may not qualify if:
- Prior surgery on affected knee
- History of prior infection in affected knee
- Regular use of tobacco or nicotine in any form
- Use of corticosteroid within last 6 months
- Ever underwent chemotherapy treatment
- History of sickle cell disease
- History of anaphylaxis
- Any condition that could affect healing (Diabetes, inflammatory arthritis, etc)
- Diagnosis of posterolateral corner injury (LCL complete tear, Biceps femoris tendon avulsion, tear of the arcuate ligament, tear of the popliteus ligament)
- Diagnosis of Grade III medial collateral ligament injury
- Diagnosis of complete patellar dislocation
- ACL deemed normal on arthroscopic inspection
- Time from injury to surgery is greater than 90 days (for Comparator group) and greater than 30 days (for Experimental group)
- Experimental Group: Less than 50 percent of ACL remaining
- Displaced bucket handle meniscal injury requiring repair
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (3)
Murray MM, Flutie BM, Kalish LA, Ecklund K, Fleming BC, Proffen BL, Micheli LJ. The Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) Procedure: An Early Feasibility Cohort Study. Orthop J Sports Med. 2016 Nov 21;4(11):2325967116672176. doi: 10.1177/2325967116672176. eCollection 2016 Nov.
PMID: 27900338BACKGROUNDBarnett 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.
PMID: 34988237DERIVEDKiapour AM, Ecklund K, Murray MM; BEAR Trial Team; Flutie B, Freiberger C, Henderson R, Kramer D, Micheli L, Thurber L, Yen YM, Fleming BC. Changes in Cross-sectional Area and Signal Intensity of Healing Anterior Cruciate Ligaments and Grafts in the First 2 Years After Surgery. Am J Sports Med. 2019 Jul;47(8):1831-1843. doi: 10.1177/0363546519850572. Epub 2019 Jun 5.
PMID: 31166701DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lyle Micheli, MD
Boston Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2014
First Posted
November 17, 2014
Study Start
January 1, 2015
Primary Completion
March 19, 2018
Study Completion (Estimated)
December 31, 2026
Last Updated
December 17, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share