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BioCleanse Tibialis Tendon Anterior Cruciate Ligament (ACL) Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by RTI Biologics
Sponsor:
Information provided by (Responsible Party):
RTI Biologics
ClinicalTrials.gov Identifier:
NCT00975845
First received: September 10, 2009
Last updated: November 11, 2014
Last verified: November 2014

September 10, 2009
November 11, 2014
December 2009
January 2017   (final data collection date for primary outcome measure)
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 ]
Objective International Knee Documentation Committee (IKDC) (KT) Exam [ Time Frame: pre-op, 2 months, 4 months, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00975845 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
BioCleanse Tibialis Tendon Anterior Cruciate Ligament (ACL) Study
A Prospective, Double-Blind Evaluation of the Effects of BioCleanse Tibialis Tendon Allograft and Donor Age on Clinical Outcomes of ACL Reconstruction

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.

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Anterior Cruciate Ligament Rupture
Other: BioCleanse Tibialis tendon
Outcomes of anterior cruciate replacement will be evaluated
Other Name: BioCleanse tibialis tendon
BioCleanse Tibialis Tendon Allograft
Tibialis Tendon allograft from donor 18-65 years old
Intervention: Other: BioCleanse Tibialis tendon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
January 2017
January 2017   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact: Margie Aguayo 602-512-8476 tcarter@tocamd.com
United States
 
NCT00975845
BCTib 2008
No
RTI Biologics
RTI Biologics
Not Provided
Principal Investigator: Thomas Carter, MD Foundation for Orthopedic Research and Education
RTI Biologics
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP