This trial is active, not recruiting.

Condition anterior cruciate ligament rupture
Treatment biocleanse tibialis tendon
Phase phase 4
Sponsor RTI Surgical
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Tibialis Tendon allograft from donor 18-65 years old
biocleanse tibialis tendon
Outcomes of anterior cruciate replacement will be evaluated

Primary Outcomes

Objective International Knee Documentation Committee (IKDC) Exam
time frame: pre-op, 2 months, 4 months, 6 months, 12 months, 24 months

Secondary Outcomes

Subjective quality of life scores
time frame: pre-op, 2 months, 4 months, 6 months, 12 months, and 24 months

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: 1. Study subjects will be limited to those subjects undergoing allograft anterior cruciate ligament reconstruction surgery 2. Meniscal injuries may be included 3. Isolated, unilateral anterior cruciate ligament injury. 4. All subjects will have a minimum age of eighteen (18) years and a maximum of sixty (60) years. 5. Both male and non-pregnant female subjects will be included. 6. 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. 7. 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: 1. No chondral defects 2. Failure to comply with or meet all of the inclusion criteria listed above. 3. Autograft anterior cruciate ligament surgery on either knee. 4. Anterior cruciate ligament injury on contra-lateral leg at any time 5. Multi-ligament reconstruction 6. Inability to comply with all requirements of this investigation, as well as follow the instructions of the physician. 7. Significant systemic disease or conditions which impact overall health or well being or which necessitate chronic medication use. 8. Revision anterior cruciate ligament surgery to either knee at anytime 9. Exhibiting signs of moderate to severe degenerative joint disease in addition to requiring anterior cruciate ligament surgery. 10. Concomitant injuries to the knee or lower extremities requiring treatment, per surgeon's discretion.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by RTI Surgical.