BioCleanse Tibialis Tendon Anterior Cruciate Ligament (ACL) Study
United States40 participantsStarted 2017-11-09
Plain-language summary
To compare the outcome of Anterior Cruciate Ligament (ACL) reconstruction performed using the tibialis allograft to historical outcomes of ACL reconstruction patients and to establish if any correlation exists between the age of the graft donor and the clinical outcomes.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Study subjects will be limited to those subjects undergoing allograft anterior cruciate ligament reconstruction surgery
✓. All subjects will have a minimum age of eighteen (18) years and a maximum of sixty (60) years.
✓. Both male and non-pregnant female subjects will be included.
✓. To facilitate follow-up, study subjects will be limited to the local geographic area of the study site and be willing to use the rehabilitation facility and physical therapy schedule assigned by the surgeon.
✓. All subjects must be able to read, write, and comprehend instructions and guidelines in English and understand (and sign as an acknowledgment of their understanding) an informed consent declaration.
Exclusion criteria
✕. No chondral defects
✕. Failure to comply with or meet all of the inclusion criteria listed above.
✕. Autograft anterior cruciate ligament surgery on either knee.
✕. Anterior cruciate ligament injury on contra-lateral leg at any time
✕. Multi-ligament reconstruction
What they're measuring
1
Objective International Knee Documentation Committee (IKDC) Exam