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Bridge-Enhanced ACL Repair vs ACL Reconstruction

Primary Purpose

Anterior Cruciate Ligament Tear

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BEAR Scaffold
Tendon Graft
Sponsored by
Miach Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Tear

Eligibility Criteria

14 Years - 35 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age: 14 to 35 years of age.
  • Sex: Both male and female
  • ACL: Complete tear
  • Time from injury to surgery: ≤45 days
  • MRI: ACL tissue present on pre-operative MRI - at least 50% of the ACL length must still be attached to the tibial plateau

Exclusion Criteria:

  • Prior surgery on affected knee
  • Prior joint infection on affected knee
  • Regular use of tobacco or nicotine
  • Use of corticosteroid within last 3 months
  • History of chemotherapy treatment
  • History of sickle cell disease
  • History of anaphylaxis
  • Any condition that could affect healing or infection risk (Diabetes, inflammatory arthritis, etc)
  • Operative posterolateral corner injury (LCL complete tear, Biceps femoris tendon avulsion, tear of the arcuate ligament, tear of the popliteus ligament)
  • Grade III medial collateral ligament injury
  • Complete patellar dislocation
  • Known allergy to bovine, beef or cow products

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bridge-Enhanced ACL Repair (BEAR)

Tendon Graft

Arm Description

The BEAR technique involves surgically placing a sponge (the BEAR scaffold) between the torn ends of the ACL, providing a scaffold for the ligament ends to grow into.

ACL reconstruction is when a tendon graft (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee) is taken and used to replace the torn ACL.

Outcomes

Primary Outcome Measures

Patient Reported Outcomes Score
This is a survey taken by patients to report how their knee is working for them.
Instrumented Anteroposterior (AP) laxity testing
This is a test of how stable the knee is.

Secondary Outcome Measures

Hamstring and Quadriceps Strength
Measured by a hand-held dynamometer on both the involved and contralateral knees
Patient Reported Outcomes Score
This is a survey taken by patients to report how their knee is working for them
X-ray Imaging
A semiflexed weight bearing MTP view, as well as a lateral projection
MR imaging
MR imaging with the CISS sequence will be used to measure the volume and orientation of both the repaired knee and the contralateral knee

Full Information

First Posted
January 20, 2016
Last Updated
September 10, 2021
Sponsor
Miach Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT02664545
Brief Title
Bridge-Enhanced ACL Repair vs ACL Reconstruction
Official Title
A Prospective, Randomized, Controlled, Clinical Trial Evaluating the Non-Inferiority of Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) to Anterior Cruciate Ligament Reconstruction With an Autologous Tendon Graft (ACLR)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2016 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
May 2028 (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
The goal of this trial is to compare the efficacy of the Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR™) technique with the current method of treatment for anterior cruciate ligament (ACL) injuries, ACL reconstruction.
Detailed Description
Enrolled patients will be randomized to either the Bridge-Enhanced ACL Repair (BEAR) technique (new treatment) or an ACL reconstruction (current gold standard of treatment).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bridge-Enhanced ACL Repair (BEAR)
Arm Type
Experimental
Arm Description
The BEAR technique involves surgically placing a sponge (the BEAR scaffold) between the torn ends of the ACL, providing a scaffold for the ligament ends to grow into.
Arm Title
Tendon Graft
Arm Type
Active Comparator
Arm Description
ACL reconstruction is when a tendon graft (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee) is taken and used to replace the torn ACL.
Intervention Type
Device
Intervention Name(s)
BEAR Scaffold
Intervention Description
A sponge, or scaffold, which is surgically placed between the torn ligament ends and sutures are used to repair the torn anterior cruciate ligament.
Intervention Type
Procedure
Intervention Name(s)
Tendon Graft
Intervention Description
A graft of tendon (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee)
Primary Outcome Measure Information:
Title
Patient Reported Outcomes Score
Description
This is a survey taken by patients to report how their knee is working for them.
Time Frame
2 years after surgery
Title
Instrumented Anteroposterior (AP) laxity testing
Description
This is a test of how stable the knee is.
Time Frame
2 years after surgery
Secondary Outcome Measure Information:
Title
Hamstring and Quadriceps Strength
Description
Measured by a hand-held dynamometer on both the involved and contralateral knees
Time Frame
3 months to 2 years out from surgery
Title
Patient Reported Outcomes Score
Description
This is a survey taken by patients to report how their knee is working for them
Time Frame
Baseline, 6 months, 1 year and 6 and 10 years after surgery.
Title
X-ray Imaging
Description
A semiflexed weight bearing MTP view, as well as a lateral projection
Time Frame
Baseline and 2, 6 and 10 years after surgery.
Title
MR imaging
Description
MR imaging with the CISS sequence will be used to measure the volume and orientation of both the repaired knee and the contralateral knee
Time Frame
Baseline and 2, 6 and 10 years after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age: 14 to 35 years of age. Sex: Both male and female ACL: Complete tear Time from injury to surgery: ≤45 days MRI: ACL tissue present on pre-operative MRI - at least 50% of the ACL length must still be attached to the tibial plateau Exclusion Criteria: Prior surgery on affected knee Prior joint infection on affected knee Regular use of tobacco or nicotine Use of corticosteroid within last 3 months History of chemotherapy treatment History of sickle cell disease History of anaphylaxis Any condition that could affect healing or infection risk (Diabetes, inflammatory arthritis, etc) Operative posterolateral corner injury (LCL complete tear, Biceps femoris tendon avulsion, tear of the arcuate ligament, tear of the popliteus ligament) Grade III medial collateral ligament injury Complete patellar dislocation Known allergy to bovine, beef or cow products
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Krammer, 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
36263311
Citation
Menghini D, Kaushal SG, Flannery SW, Ecklund K; BEAR Trial Team; Murray MM, Fleming BC, Kiapour AM, Proffen B, Sant N, Portilla G, Sanborn R, Freiberger C, Henderson R, Barnett S, Yen YM, Kramer DE, Micheli LJ. Changes in the Cross-Sectional Profile of Treated Anterior Cruciate Ligament Within 2 Years After Surgery. Orthop J Sports Med. 2022 Oct 14;10(10):23259671221127326. doi: 10.1177/23259671221127326. eCollection 2022 Oct.
Results Reference
derived
PubMed Identifier
35155707
Citation
Sanborn RM, Badger GJ; BEAR Trial Team; Yen YM, Murray MM, Christino MA, Proffen B, Sant N, Barnett S, Fleming BC, Kramer DE, Micheli LJ. Psychological Readiness to Return to Sport at 6 Months Is Higher After Bridge-Enhanced ACL Restoration Than Autograft ACL Reconstruction: Results of a Prospective Randomized Clinical Trial. Orthop J Sports Med. 2022 Feb 9;10(2):23259671211070542. doi: 10.1177/23259671211070542. eCollection 2022 Feb.
Results Reference
derived
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
34778483
Citation
Barnett SC, Murray MM, Badger GJ; BEAR Trial Team; Yen YM, Kramer DE, Sanborn R, Kiapour A, Proffen B, Sant N, Fleming BC, Micheli LJ. Earlier Resolution of Symptoms and Return of Function After Bridge-Enhanced Anterior Cruciate Ligament Repair As Compared With Anterior Cruciate Ligament Reconstruction. Orthop J Sports Med. 2021 Nov 9;9(11):23259671211052530. doi: 10.1177/23259671211052530. eCollection 2021 Nov.
Results Reference
derived
PubMed Identifier
32298131
Citation
Murray MM, Fleming BC, Badger GJ; BEAR Trial Team; Freiberger C, Henderson R, Barnett S, Kiapour A, Ecklund K, Proffen B, Sant N, Kramer DE, Micheli LJ, Yen YM. Bridge-Enhanced Anterior Cruciate Ligament Repair Is Not Inferior to Autograft Anterior Cruciate Ligament Reconstruction at 2 Years: Results of a Prospective Randomized Clinical Trial. Am J Sports Med. 2020 May;48(6):1305-1315. doi: 10.1177/0363546520913532. Epub 2020 Apr 16.
Results Reference
derived
PubMed Identifier
30986359
Citation
Murray MM, Kiapour AM, Kalish LA, Ecklund K; BEAR Trial Team; Freiberger C, Henderson R, Kramer D, Micheli L, Yen YM, Fleming BC. Predictors of Healing Ligament Size and Magnetic Resonance Signal Intensity at 6 Months After Bridge-Enhanced Anterior Cruciate Ligament Repair. Am J Sports Med. 2019 May;47(6):1361-1369. doi: 10.1177/0363546519836087. Epub 2019 Apr 15.
Results Reference
derived

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Bridge-Enhanced ACL Repair vs ACL Reconstruction

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