BioCleanse Tibialis Tendon Anterior Cruciate Ligament (ACL) Study
This study is currently recruiting participants.
Verified January 2013 by RTI Biologics
Sponsor:
RTI Biologics
Information provided by (Responsible Party):
RTI Biologics
ClinicalTrials.gov Identifier:
NCT00975845
First received: September 10, 2009
Last updated: January 23, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anterior Cruciate Ligament Rupture |
Other: BioCleanse Tibialis tendon |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Prospective, Double-Blind Evaluation of the Effects of BioCleanse Tibialis Tendon Allograft and Donor Age on Clinical Outcomes of ACL Reconstruction |
Resource links provided by NLM:
Further study details as provided by RTI Biologics:
Primary Outcome Measures:
- Objective International Knee Documentation Committee (IKDC) Exam [ Time Frame: pre-op, 2 months, 4 months, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Subjective quality of life scores [ Time Frame: pre-op, 2 months, 4 months, 6 months, 12 months, and 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Other Name: BioCleanse tibialis tendon
|
Detailed 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. All patients will receive a BioCleanse Tibialis graft recovered from donors 18-65 years old. Follow up is for two years.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
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
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00975845
Contacts
| Contact: Margie Aguayo | 602-512-8476 | tcarter@tocamd.com |
Locations
| United States, Arizona | |
| The Orthopedic Clinic, Assoc | Recruiting |
| Phoenix, Arizona, United States, 85016 | |
| Contact: Margie Aguayo 602-512-8476 tcarter@tocamd.com | |
| Principal Investigator: Thomas Carter, MD | |
Sponsors and Collaborators
RTI Biologics
Investigators
| Principal Investigator: | Thomas Carter, MD | Foundation for Orthopedic Research and Education |
More Information
No publications provided
| Responsible Party: | RTI Biologics |
| ClinicalTrials.gov Identifier: | NCT00975845 History of Changes |
| Other Study ID Numbers: | BCTib 2008 |
| Study First Received: | September 10, 2009 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by RTI Biologics:
|
ACL Anterior Cruciate Ligament Torn tendon ACL Repair ACL reconstruction |
Additional relevant MeSH terms:
|
Rupture Wounds and Injuries |
ClinicalTrials.gov processed this record on June 18, 2013