Clinical trial NCT02292004: Bridge-Enhanced ACL Repair-Safety Study (BEAR Trial)
Official title: Bridge-Enhanced ACL Repair-Safety Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Injury
Anterior Cruciate Ligament Tear
Lead sponsor: Miach Orthopaedics
Sponsor class: INDUSTRY
First posted: 2014-11-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: Safety and tolerability of the BEAR® Implant
timeFrame: Surgery to 3-months post-op
Secondary outcomes:
measure: Inflammatory reaction
timeFrame: Surgery to 3-months post-op
measure: Muscle Atrophy
timeFrame: At 6-weeks post-op
measure: Excessive Pain
timeFrame: Surgery to 3-months post-op
measure: Implant failure
timeFrame: At 3-months post-op
measure: Anteroposterior (AP) knee laxity
timeFrame: At 6- and 12-months post-op
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Lyle Micheli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hall TL, Thompson RW. Interhemispheric transfer as a function of light intensity discrimination difficulty. J Comp Physiol Psychol. 1971 Oct;77(1):166-70. doi: 10.1037/h0031569. No abstract available.
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.
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.