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

Bridge-Enhanced ACL Repair-Safety Study

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.)

Study Overview

• Status: Active, not recruiting
• Conditions: Anterior Cruciate Ligament Tear; Anterior Cruciate Ligament Injury
• Intervention / Treatment: Device: ACL Repair with MIACH Scaffold; Procedure: Standard ACL Reconstruction

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACL repair with MIACH scaffold; Patients will undergo ACL repair surgery using the newly developed MIACH scaffold	Device: ACL Repair with MIACH Scaffold; Surgical insertion of the MIACH scaffold to promote ACL healing/repair
Active Comparator: Standard ACL reconstruction; Patients will undergo a standard ACL reconstruction surgery	Procedure: Standard ACL Reconstruction; Standard surgical reconstruction of the ACL with autograft hamstring tendon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Miach Orthopaedics
• Investigators: Study Director: Martha Murray, MD, Boston Children's Hospital; Principal Investigator: Lyle Micheli, MD, Boston Children's Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• Kiapour 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: November 12, 2014
• First Submitted That Met QC Criteria: November 14, 2014
• First Posted (Estimated): November 17, 2014

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: IRB-P00012985

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Clinical Study Report
   Information identifier: 10.1177/2325967116672176
   Information comments: This is the paper publishing the three-month results of the BEAR I study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes