BioCleanse Tibialis Tendon Anterior Cruciate Ligament (ACL) Study
|ClinicalTrials.gov Identifier: NCT00975845|
Recruitment Status : Completed
First Posted : September 11, 2009
Last Update Posted : February 6, 2018
|Condition or disease||Intervention/treatment|
|Anterior Cruciate Ligament Rupture||Other: BioCleanse Tibialis tendon|
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.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||A Prospective, Double-Blind Evaluation of the Effects of BioCleanse Tibialis Tendon Allograft and Donor Age on Clinical Outcomes of ACL Reconstruction|
|Actual Study Start Date :||November 9, 2017|
|Primary Completion Date :||November 9, 2017|
|Study Completion Date :||November 9, 2017|
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
- Objective International Knee Documentation Committee (IKDC) Exam [ Time Frame: pre-op, 2 months, 4 months, 6 months, 12 months, 24 months ]The International Knee Documentation Committee (IKDC) is a knee-specific patient-reported outcome measure. This is an indexed score form 0-100, with 0 being the worst possible status and 100 indicating no dysfunction, disability or pain.
- Subjective quality of life scores [ Time Frame: pre-op, 2 months, 4 months, 6 months, 12 months, and 24 months ]The SF36 measures the quality life as reported by the paritricpantm, and is an indexed score form 0 - 100. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975845
|United States, Arizona|
|The Orthopedic Clinic, Assoc|
|Phoenix, Arizona, United States, 85016|
|Principal Investigator:||Thomas Carter, MD||Foundation for Orthopedic Research and Education|