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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.)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACL repair with MIACH scaffold | Experimental | Patients will undergo ACL repair surgery using the newly developed MIACH scaffold |
|
| Standard ACL reconstruction | Active Comparator | Patients will undergo a standard ACL reconstruction surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACL Repair with MIACH Scaffold | Device | Surgical insertion of the MIACH scaffold to promote ACL healing/repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of the BEAR® Implant | To assess the safety (implant rejection, infection, joint effusion, muscle atrophy, knee laxity) and tolerability of the BEAR® implant | Surgery to 3-months post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory reaction | Tense effusion limiting motion, fever or increased knee pain for more than three weeks after surgery and synovial fluid culture is negative for organisms. | Surgery to 3-months post-op |
| Muscle Atrophy |
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Inclusion Criteria:
Exclusion Criteria (before surgery):
Exclusion Criteria (during surgery):
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Kramer, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27900338 | Background | Murray MM, Flutie BM, Kalish LA, Ecklund K, Fleming BC, Proffen BL, Micheli LJ. The Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) Procedure: An Early Feasibility Cohort Study. Orthop J Sports Med. 2016 Nov 21;4(11):2325967116672176. doi: 10.1177/2325967116672176. eCollection 2016 Nov. | |
| 34988237 | Derived |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| Standard ACL Reconstruction | Procedure | Standard surgical reconstruction of the ACL with autograft hamstring tendon |
|
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.
| At 6-weeks post-op |
| Excessive Pain | 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. | Surgery to 3-months post-op |
| Implant failure | 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. | At 3-months post-op |
| Anteroposterior (AP) knee laxity | 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. | At 6- and 12-months post-op |
| 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. |
| 31166701 | Derived | 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. |