Clinical trial NCT02664545: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Tear
Lead sponsor: Miach Orthopaedics
Sponsor class: INDUSTRY
First posted: 2016-01-27
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: International Knee Documentation Committee (IKDC) Subjective
timeFrame: 2 years after surgery
measure: Instrumented Anteroposterior (AP) Laxity Testing
timeFrame: 2 years after surgery
Secondary outcomes:
measure: Prone Hamstring Strength at 6 Months
timeFrame: 6 months
measure: Return to Sport (RSI) Patient Reported Outcomes Score at 6 Months.
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Yi-Meng Yen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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: 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.
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.
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.