Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.
This is a Humanitarian Device Exemption (HDE) approved device called the Patient Specific Talus Spacer. This is a post approval study to determine the safety and probable benefit of the Patient Specific Talus Spacer in commercial use. The Patient Specific Talus Spacer is a solid polished replica of the patient's bone to allow the patient to regain motion and reduce pain.
Study Type
OBSERVATIONAL
Enrollment
50
Patient Specific Talus Spacer is a solid polished replica of the patient's bone.
Redwood Orthopaedics
Santa Rosa, California, United States
RECRUITINGFort Wayne Orthopedics
Fort Wayne, Indiana, United States
RECRUITINGMercy Institute for Foot & Ankle Reconstruction
Baltimore, Maryland, United States
Clinically Significant Improvement in Pain on the Visual Analog Scale (VAS)
Clinically Significant Improvement in Pain on the Visual Analog Scale (VAS) at 5 years compared to baseline on the 0 to 100mm scale. A lower score will indicate an improvement in pain.
Time frame: At 5 years compared to Baseline
A lack Secondary Subsequent Surgical Intervention at 5 years Post Operative assessed during the subject's visits
A lack Secondary Subsequent Surgical Intervention (SSSI) at 5 years Post Operative
Time frame: A patient will achieve the primary probable benefit endpoint only is they do not undergo a Secondary Subsequent Surgical Intervention at 5 years Post Operative as assessed during the subjects visits for the study.
Additional Analyses at 5 years Post Operative compared to baseline, Range of Motion of the Ankle.
Additional analyses will be performed to observe improvement at 5-years post-procedure compared to baseline on ankle range of motion (ROM) as assessed by the surgeon at each follow up visit through 5 years Post Operative.
Time frame: 5 Years Post Procedure compared to baseline.
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Duke Orthopeadics Arringdon
Morrisville, North Carolina, United States
RECRUITINGMedical University of South Carolina
Charleston, South Carolina, United States
RECRUITINGUT Physicians Orthopedics - Pearland
Pearland, Texas, United States
RECRUITING