At a glance
ClinicalIndex Comparison RecordN/ACompleted· 148 enrolled
Drug / intervention
Treatment of insufficiency fracturesdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Foot/Ankle
In Brief
An observational study evaluating Treatment of insufficiency fractures for Insufficiency Fractures and 2 related conditions. Completed, enrolled 148 participants across 12 sites in 2 countries.
Detailed Summary
Post Market clinical outcomes study to collect data on the short - and long-term outcomes for subjects who are undergoing or who have undergone the Subchondroplasty Procedure in the foot and/or ankle in a standard clinical setting. Outcomes to be assessed include pain medication usage, pain, function, activity levels and patient satisfaction.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
Enrollment StartMar 2017
First PostedMar 2017
Primary CompletionAug 2023
TodayJul 2026
First PostedMar 22, 2017
Enrollment StartMar 10, 2017
Primary CompletionAug 23, 2023
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 9.3 years ago
Interventions
Treatment of insufficiency fracturesdevice
Filling of micro fractures or insufficiency fractures with a bone substitute material