BioCleanse Tibialis Tendon Anterior Cruciate Ligament (ACL) Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Double-Blind Evaluation of the Effects of BioCleanse Tibialis Tendon Allograft and Donor Age on Clinical Outcomes of ACL Reconstruction

Conditions
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Anterior Cruciate Ligament Rupture

Intervention / Treatment
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* Other: BioCleanse Tibialis tendon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Study subjects will be limited to those subjects undergoing allograft anterior cruciate ligament reconstruction surgery Meniscal injuries may be included Isolated, unilateral anterior cruciate ligament injury. All subjects will have a minimum age of eighteen (18) years and a maximum of sixty (60) years. Both male and non-pregnant female subjects will be included. 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. 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: No chondral defects Failure to comply with or meet all of the inclusion criteria listed above. Autograft anterior cruciate ligament surgery on either knee. Anterior cruciate ligament injury on contra-lateral leg at any time Multi-ligament reconstruction Inability to comply with all requirements of this investigation, as well as follow the instructions of the physician. Significant systemic disease or conditions which impact overall health or well being or which necessitate chronic medication use. Revision anterior cruciate ligament surgery to either knee at anytime Exhibiting signs of moderate to severe degenerative joint disease in addition to requiring anterior cruciate ligament surgery. Concomitant injuries to the knee or lower extremities requiring treatment, per surgeon's discretion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BioCleanse Tibialis Tendon Allograft<br>Tibialis Tendon allograft from donor 18-65 years old | Other: BioCleanse Tibialis tendon<br>* Outcomes of anterior cruciate replacement will be evaluated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective International Knee Documentation Committee (IKDC) Exam | 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. | pre-op, 2 months, 4 months, 6 months, 12 months, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective quality of life scores | 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 | pre-op, 2 months, 4 months, 6 months, 12 months, and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACL, Anterior Cruciate Ligament, Torn tendon, ACL Repair, ACL reconstruction