BioCleanse Tibialis Tendon Anterior Cruciate Ligament (ACL) Study
This trial is active, not recruiting.
|Condition||anterior cruciate ligament rupture|
|Treatment||biocleanse tibialis tendon|
|Start date||December 2009|
|End date||July 2017|
|Trial size||50 participants|
|Trial identifier||NCT00975845, BCTib 2008|
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 what, if any, correlation exists between the age of the graft donor and the clinical outcomes.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
|Masking||double blind (subject, investigator)|
Tibialis Tendon allograft from donor 18-65 years old
Objective International Knee Documentation Committee (IKDC) Exam
time frame: pre-op, 2 months, 4 months, 6 months, 12 months, 24 months
Subjective quality of life scores
time frame: pre-op, 2 months, 4 months, 6 months, 12 months, and 24 months
Male or female participants from 18 years up to 60 years old.
- Study subjects will be limited to those subjects undergoing allograft anterior cruciate ligament reconstruction surgery
- Meniscal injuries may be included
- Isolated, unilateral anterior cruciate ligament injury.
- 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.
- 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
- Inability to comply with all requirements of this investigation, as well as follow the instructions of the physician.
- Significant systemic disease or conditions which impact overall health or well being or which necessitate chronic medication use.
- Revision anterior cruciate ligament surgery to either knee at anytime
- Exhibiting signs of moderate to severe degenerative joint disease in addition to requiring anterior cruciate ligament surgery.
- Concomitant injuries to the knee or lower extremities requiring treatment, per surgeon's discretion.
|Official title||A Prospective, Double-Blind Evaluation of the Effects of BioCleanse Tibialis Tendon Allograft and Donor Age on Clinical Outcomes of ACL Reconstruction|
|Principal investigator||Thomas Carter, MD|
|Description||This is a double-blind (the surgeon is also blinded), single-arm, single site, pilot study in subjects with a ruptured anterior cruciate ligament. A total of fifty (N=50) subjects will be enrolled in this trial. One group of patients will receive a BioCleanse Tibialis graft recovered from donors 18-45 of age and the other group received grafts from donors over 46 years of age. Follow up is for two years. This is a single arm study in which all patients will receive a BioCleanse Tibialis allograft for ACL reconstruction. The age of the allograft donor constitutes the different groups.|
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