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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: April 18, 2017
Last verified: April 2017
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 if any correlation exists between the age of the graft donor and the clinical outcomes.

Condition Intervention
Anterior Cruciate Ligament Rupture Other: BioCleanse Tibialis tendon

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Double-Blind Evaluation of the Effects of BioCleanse Tibialis Tendon Allograft and Donor Age on Clinical Outcomes of ACL Reconstruction

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 ]

Secondary Outcome Measures:
  • Subjective quality of life scores [ Time Frame: pre-op, 2 months, 4 months, 6 months, 12 months, and 24 months ]

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)
Groups/Cohorts 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 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:

  1. 18-45 years of age
  2. 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.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have had reconstruction of the anterior cruciate ligament and have received a BioCleanse Tibialis allograft for ACL reconstruction.

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 identifier: NCT00975845

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

Responsible Party: RTI Surgical Identifier: NCT00975845     History of Changes
Other Study ID Numbers: BCTib 2008
Study First Received: September 10, 2009
Last Updated: April 18, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Wounds and Injuries processed this record on September 19, 2017