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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: April 18, 2017
Last verified: April 2017

September 10, 2009
April 18, 2017
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 ]
Objective International Knee Documentation Committee (IKDC) (KT) Exam [ Time Frame: pre-op, 2 months, 4 months, 6 months, 12 months, 24 months ]
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 ]
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 if any correlation exists between the age of the graft donor and the clinical outcomes.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients who have had reconstruction of the anterior cruciate ligament and have received a BioCleanse Tibialis allograft for ACL reconstruction.
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
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.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00975845
BCTib 2008
No
Not Provided
No
Not Provided
RTI Surgical
RTI Surgical
Not Provided
Principal Investigator: Thomas Carter, MD Foundation for Orthopedic Research and Education
RTI Surgical
April 2017

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