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BioCleanse Tibialis Tendon Anterior Cruciate Ligament (ACL) Study

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

September 10, 2009
September 12, 2016
December 2009
July 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 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. 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.

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
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 Identifier (NCT Number) in Medline.
Active, not recruiting
July 2017
July 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.
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
BCTib 2008
Not Provided
RTI Surgical
RTI Surgical
Not Provided
Principal Investigator: Thomas Carter, MD Foundation for Orthopedic Research and Education
RTI Surgical
September 2016

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