Patient Specific Talus Spacer Post Approval Study
ConditionAvascular Necrosis of the Talus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorParagon 28
About this trial
Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject plans to undergo implantation of the Patient Specific Talus Spacer for avascular necrosis of the ankle joint independent of this research protocol;
Avascular necrosis of the ankle joint;
Age 21 years old or older;
Subject has good general health; and
Disqualifiers
Presence of any contraindication identified in the device Instructions for Use;
Surgeon determines that the patient is not appropriate for the Talus Spacer procedure based on the device IFU (including the enumerated Warnings and Precautions);
Based on the medical opinion of the surgeon, the patient is not appropriate for the Talus Spacer procedure;
For female subjects, pregnancy;
Trial population
Patients with Avascular Necrosis of the Ankle Joint.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Patient Specific Talus Spacer
DevicePatient Specific Talus Spacer is a solid polished replica of the patient's bone.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: 50 Subjects1 intervention
Trial outcomes
Primary outcomes
1
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 Baseline2
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.Secondary outcomes
1
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.Other outcomes
1
Additional Analyses at 5 Years Post Operative compared to Baseline for Foot and Outcome Score FAOS
Additional analyses will be performed to observe improvement at 5-years post-procedure compared to baseline on Foot and Ankle Outcome Score (FAOS - which include Pain, Other Symptoms, Sport and Recreation Function, Activities of Daily Living (ADL) and Foot and Ankle related Quality of Life (QOL). This is a series of questions for each sub section that the subject will answer at the subjects visits.
Time frame
5 Years Post Procedure compared to baseline Source ClinicalTrials.gov