BioCleanse Tibialis Tendon Anterior Cruciate Ligament (ACL) Study
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Prospective, Double-Blind Evaluation of the Effects of BioCleanse Tibialis Tendon Allograft and Donor Age on Clinical Outcomes of ACL Reconstruction|
- 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 ]
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||July 2017|
|Estimated Primary Completion Date:||July 2017 (Final data collection date for primary outcome measure)|
BioCleanse Tibialis Tendon Allograft
Tibialis Tendon allograft from donor 18-65 years old
Other: BioCleanse Tibialis tendon
Outcomes of anterior cruciate replacement will be evaluated
This is a single-arm, single site, pilot study in patients with a ruptured ACL.. A total of fifty (50) subjects will be enrolled in this trial. All patients will have been scheduled to undergo ACL reconstruction and will receive a BioCleanse Tibialis allograft as part of the normal standard of care practiced by the treating surgeon. Follow up is for 2 years.
The age of the allograft donor will be divided into 2 groups:
- 18-45 years of age
- over 45 years of age.
However, there is no assignment of graft, specific to donor age, to the patients. All treatment will follow standard of care and this study assumes that there will be a normal distribution of graft donor ages, from 18 to 65 years of age.
Patient outcomes will be compared between the 2 groups of tendon donor ages. Neither the surgeon nor the patient will be aware of the age of the graft donor, per typical standard of care.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00975845
|United States, Arizona|
|The Orthopedic Clinic, Assoc|
|Phoenix, Arizona, United States, 85016|
|Principal Investigator:||Thomas Carter, MD||Foundation for Orthopedic Research and Education|