BioCleanse Tibialis Tendon Anterior Cruciate Ligament (ACL) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00975845
Recruitment Status : Completed
First Posted : September 11, 2009
Last Update Posted : February 6, 2018
Information provided by (Responsible Party):
RTI Surgical

Brief Summary:
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 or disease Intervention/treatment
Anterior Cruciate Ligament Rupture Other: BioCleanse Tibialis tendon

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.

Study Type : Observational
Estimated Enrollment : 50 participants
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
Actual Study Start Date : November 9, 2017
Primary Completion Date : November 9, 2017
Study Completion Date : November 9, 2017

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Objective International Knee Documentation Committee (IKDC) Exam [ Time Frame: pre-op, 2 months, 4 months, 6 months, 12 months, 24 months ]
    The International Knee Documentation Committee (IKDC) is a knee-specific patient-reported outcome measure. This is an indexed score form 0-100, with 0 being the worst possible status and 100 indicating no dysfunction, disability or pain.

Secondary Outcome Measures :
  1. Subjective quality of life scores [ Time Frame: pre-op, 2 months, 4 months, 6 months, 12 months, and 24 months ]
    The SF36 measures the quality life as reported by the paritricpantm, and is an indexed score form 0 - 100. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: RTI Surgical Identifier: NCT00975845     History of Changes
Other Study ID Numbers: BCTib 2008
First Posted: September 11, 2009    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018
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:
Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries