Bridge-Enhanced ACL Repair-Safety Study (BEAR Trial)

Anterior Cruciate Ligament Injury Clinical Trial

— BEAR  

Official title:

Bridge-Enhanced ACL Repair-Safety Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02292004
• Other study ID #: IRB-P00012985
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2015
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: Miach Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.)

Description:

This is a first-in-human trial for evaluation of the safety (Primary Objective) and short-term efficacy (Secondary Objective) of the MIACH™ ACL scaffold and will be carried out in form of an observational study of 20 patients: 10 experimental and 10 control.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: February 2025
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria (before surgery):

• 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

Exclusion Criteria (during surgery):

• 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
• Diagnosis of full-thickness chondral injury on either condyle
• Grade III medial collateral ligament injury

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Injury
• Anterior Cruciate Ligament Tear

Intervention

Device:
• ACL Repair with MIACH Scaffold
Surgical insertion of the MIACH scaffold to promote ACL healing/repair

Procedure:
• Standard ACL Reconstruction
Standard surgical reconstruction of the ACL with autograft hamstring tendon

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Miach Orthopaedics

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Inflammatory reaction	Tense effusion limiting motion, fever or increased knee pain for more than three weeks after surgery and synovial fluid culture is negative for organisms.	Surgery to 3-months post-op
Secondary	Muscle Atrophy	Patient cannot ambulate independently and continues to require crutches for ambulation for more than six weeks after surgery as a result of the muscle weakness. Patient report leg feels unstable ambulating without crutches at six weeks after surgery.	At 6-weeks post-op
Secondary	Excessive Pain	Patient needs to be readmitted to the hospital for parenteral (IV or IM) pain medications but no other adverse event (e.g. infection or inflammation) is found.	Surgery to 3-months post-op
Secondary	Implant failure	Lachman exam demonstrates 6mm or greater AP knee laxity when the knee is in 25 degrees of flexion in the operated knee than the unoperated knee on examination by the physician in the office. Both knees will be covered and the examining physician blinded to which knee was the surgical knee prior to the testing.	At 3-months post-op
Secondary	Anteroposterior (AP) knee laxity	KT-1000 testing of AP laxity in both knees reveals a side-to-side difference of >=6mm when performed by the clinician. The knees will be covered and the examiner blinded as to which is the operated knee.	At 6- and 12-months post-op

External Links

•   BEAR Repair Two- Year Results of a First in Human Study