Status:
COMPLETED
BioCleanse Tibialis Tendon Anterior Cruciate Ligament (ACL) Study
Lead Sponsor:
RTI Surgical
Conditions:
Anterior Cruciate Ligament Rupture
Eligibility:
All Genders
18-60 years
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 correlati...
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 reco...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 9 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 9 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00975845
Start Date
November 9 2017
End Date
November 9 2017
Last Update
November 1 2021
Active Locations (1)
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1
The Orthopedic Clinic, Assoc
Phoenix, Arizona, United States, 85016