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

Primary Purpose

Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Tear

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACL Repair with MIACH Scaffold
Standard ACL Reconstruction
Sponsored by
Miach Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Anterior Cruciate Ligament Injury

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ACL repair with MIACH scaffold

Standard ACL reconstruction

Arm Description

Patients will undergo ACL repair surgery using the newly developed MIACH scaffold

Patients will undergo a standard ACL reconstruction surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
November 12, 2014
Last Updated
September 20, 2023
Sponsor
Miach Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT02292004
Brief Title
Bridge-Enhanced ACL Repair-Safety Study (BEAR Trial)
Acronym
BEAR
Official Title
Bridge-Enhanced ACL Repair-Safety Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2015 (Actual)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Miach Orthopaedics

4. Oversight

Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Tear

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACL repair with MIACH scaffold
Arm Type
Experimental
Arm Description
Patients will undergo ACL repair surgery using the newly developed MIACH scaffold
Arm Title
Standard ACL reconstruction
Arm Type
Active Comparator
Arm Description
Patients will undergo a standard ACL reconstruction surgery
Intervention Type
Device
Intervention Name(s)
ACL Repair with MIACH Scaffold
Intervention Description
Surgical insertion of the MIACH scaffold to promote ACL healing/repair
Intervention Type
Procedure
Intervention Name(s)
Standard ACL Reconstruction
Intervention Description
Standard surgical reconstruction of the ACL with autograft hamstring tendon
Primary Outcome Measure Information:
Title
Safety and tolerability of the BEAR® Implant
Description
To assess the safety (implant rejection, infection, joint effusion, muscle atrophy, knee laxity) and tolerability of the BEAR® implant
Time Frame
Surgery to 3-months post-op
Secondary Outcome Measure Information:
Title
Inflammatory reaction
Description
Tense effusion limiting motion, fever or increased knee pain for more than three weeks after surgery and synovial fluid culture is negative for organisms.
Time Frame
Surgery to 3-months post-op
Title
Muscle Atrophy
Description
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.
Time Frame
At 6-weeks post-op
Title
Excessive Pain
Description
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.
Time Frame
Surgery to 3-months post-op
Title
Implant failure
Description
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.
Time Frame
At 3-months post-op
Title
Anteroposterior (AP) knee laxity
Description
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.
Time Frame
At 6- and 12-months post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha Murray, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lyle Micheli, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27900338
Citation
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.
Results Reference
background
PubMed Identifier
34988237
Citation
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.
Results Reference
derived
PubMed Identifier
31166701
Citation
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.
Results Reference
derived

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

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