Clinical trial NCT00975845: BioCleanse Tibialis Tendon Anterior Cruciate Ligament (ACL) Study
Official title: A Prospective, Double-Blind Evaluation of the Effects of BioCleanse Tibialis Tendon Allograft and Donor Age on Clinical Outcomes of ACL Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anterior Cruciate Ligament Rupture
Keywords: ACL
Anterior Cruciate Ligament
Torn tendon
ACL Repair
ACL reconstruction
Lead sponsor: RTI Surgical
Sponsor class: INDUSTRY
First posted: 2009-09-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Objective International Knee Documentation Committee (IKDC) Exam
timeFrame: pre-op, 2 months, 4 months, 6 months, 12 months, 24 months
Secondary outcomes:
measure: Subjective quality of life scores
timeFrame: pre-op, 2 months, 4 months, 6 months, 12 months, and 24 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: The Orthopedic Clinic, Assoc
state: Arizona
Study officials:
affiliation: Foundation for Orthopedic Research and Education
name: Thomas Carter, MD
role: PRINCIPAL_INVESTIGATOR
References: