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BioCleanse Tibialis Tendon Anterior Cruciate Ligament (ACL) Study

NCT ID: NCT00975845

Last Updated: 2021-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-09

Study Completion Date

2017-11-09

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.

Conditions

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Anterior Cruciate Ligament Rupture

Keywords

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ACL Anterior Cruciate Ligament Torn tendon ACL Repair ACL reconstruction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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BioCleanse Tibialis Tendon Allograft

Tibialis Tendon allograft from donor 18-65 years old

BioCleanse Tibialis tendon

Intervention Type OTHER

Outcomes of anterior cruciate replacement will be evaluated

Interventions

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BioCleanse Tibialis tendon

Outcomes of anterior cruciate replacement will be evaluated

Intervention Type OTHER

Eligibility Criteria

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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.

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.

Exclusion Criteria

1. No chondral defects
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RTI Surgical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Carter, MD

Role: PRINCIPAL_INVESTIGATOR

Foundation for Orthopedic Research and Education

Locations

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The Orthopedic Clinic, Assoc

Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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BCTib 2008

Identifier Type: -

Identifier Source: org_study_id