Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

BioCleanse Tibialis Tendon Anterior Cruciate Ligament (ACL) Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
RTI Surgical
ClinicalTrials.gov Identifier:
NCT00975845
First received: September 10, 2009
Last updated: September 12, 2016
Last verified: September 2016
  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 Surgical:

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: July 2017
Estimated Primary Completion Date: July 2017 (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

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. 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00975845

Locations
United States, Arizona
The Orthopedic Clinic, Assoc
Phoenix, Arizona, United States, 85016
Sponsors and Collaborators
RTI Surgical
Investigators
Principal Investigator: Thomas Carter, MD Foundation for Orthopedic Research and Education
  More Information

Responsible Party: RTI Surgical
ClinicalTrials.gov Identifier: NCT00975845     History of Changes
Other Study ID Numbers: BCTib 2008 
Study First Received: September 10, 2009
Last Updated: September 12, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by RTI Surgical:
ACL
Anterior Cruciate Ligament
Torn tendon
ACL Repair
ACL reconstruction

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on September 26, 2016