Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Miach Orthopaedics
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.
Age
18–35
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
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
