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NCT Number: NCT02292004

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

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.)

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Anterior Cruciate Ligament Injury Anterior Cruciate Ligament Injuries Anterior Cruciate Ligament Tear Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACL Repair with MIACH Scaffold

Device

Surgical insertion of the MIACH scaffold to promote ACL healing/repair

Standard ACL Reconstruction

Procedure

Standard surgical reconstruction of the ACL with autograft hamstring tendon

Primary outcomes

  1. Safety and tolerability of the BEAR® Implant

    Time frame: 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 outcomes

  1. Inflammatory reaction

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Miach Orthopaedics

Industry

Registry information

Official study title

Bridge-Enhanced ACL Repair-Safety Study

Acronym: BEAR

Important dates

Study start
2015
Primary completion
2018
Study completion
2026
First posted
Nov 17, 2014
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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