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

Sponsor
Miach Orthopaedics (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02292004
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
109
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

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.)

Condition or Disease Intervention/Treatment Phase
  • Device: ACL Repair with MIACH Scaffold
  • Procedure: Standard ACL Reconstruction
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Device Feasibility
Official Title:
Bridge-Enhanced ACL Repair-Safety Study
Actual Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Feb 1, 2016
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Safety and tolerability of the BEAR® Implant [Surgery to 3-months post-op]

    To assess the safety (implant rejection, infection, joint effusion, muscle atrophy, knee laxity) and tolerability of the BEAR® implant

Secondary Outcome Measures

  1. Inflammatory reaction [Surgery to 3-months post-op]

    Tense effusion limiting motion, fever or increased knee pain for more than three weeks after surgery and synovial fluid culture is negative for organisms.

  2. Muscle Atrophy [At 6-weeks post-op]

    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.

  3. Excessive Pain [Surgery to 3-months post-op]

    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.

  4. Implant failure [At 3-months post-op]

    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.

  5. Anteroposterior (AP) knee laxity [At 6- and 12-months post-op]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Boston Children's Hospital Boston Massachusetts United States 02115

Sponsors and Collaborators

  • Miach Orthopaedics

Investigators

  • Study Director: Martha Murray, MD, Boston Children's Hospital
  • Principal Investigator: Lyle Micheli, MD, Boston Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Miach Orthopaedics
ClinicalTrials.gov Identifier:
NCT02292004
Other Study ID Numbers:
  • IRB-P00012985
First Posted:
Nov 17, 2014
Last Update Posted:
Mar 29, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Anterior Cruciate Ligament Injuries

Study Results

No Results Posted as of Mar 29, 2021