Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Tear
Conditions
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.
Interventions
DEVICEACL Repair with MIACH Scaffold
Surgical insertion of the MIACH scaffold to promote ACL healing/repair
PROCEDUREStandard ACL Reconstruction
Standard surgical reconstruction of the ACL with autograft hamstring tendon
Sponsors
Miach Orthopaedics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of the BEAR® Implant | 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
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory reaction | 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. |
| Muscle Atrophy | 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. |
| Excessive Pain | 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. |
| Implant failure | 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. |
| Anteroposterior (AP) knee laxity | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDennis Kramer, MD
Boston Children's Hospital
Outcome results
None listed