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Clinical Trial NCT06210620 for Amputation is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Pro APP Prosthetic Outcome Registry 2,000 Multi-Center Long-Term Follow-up
Clinical Trial NCT06210620 is an observational study for Amputation that is recruiting. It started on January 1, 2024 with plans to enroll 2,000 participants. Led by Össur Iceland ehf, it is expected to complete by September 1, 2033. The latest data from ClinicalTrials.gov was last updated on September 15, 2025.
Brief Summary
A national, multi-center registry of patients using lower-limb prosthesis, their profiles and devices, and their long-term follow-up and clinical outcomes.
Detailed Description
This US national patient and outcome registry will provide demographic information on lower-limb prosthesis users and their real-world clinical outcomes. The intent is to collect data from multiple certified O&P clinics that have access to use the digital data collection tool PRO App (https://www.ossur.com/en-us/professionals/PRO App). Any patient undergoing prosthetic treatment with their prescribed devices (such a...Show More
Official Title
Prospective, Observational Registry to Collect Standard of Care Clinical Testing Data From Lower-limb Prosthesis Patients Via the PRO App.
Conditions
AmputationOther Study IDs
- CIP2023092221
NCT ID Number
Start Date (Actual)
2024-01-01
Last Update Posted
2025-09-15
Completion Date (Estimated)
2033-09
Enrollment (Estimated)
2,000
Study Type
Observational
Status
Recruiting
Keywords
Registry
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Provide data on patient characteristics | The primary objective of this study is to generate a national, multi-center registry of patients using lower-limb prosthesis, their profiles and devices, and their long-term follow-up and clinical outcomes. | 10 years |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Provide data on device performance | To perform comparative analysis on the population and subgroups based on demographics, device brands, device types, device technology, patient reported outcomes, observer-reporter, and objective clinical assessments | 10 years |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Cognitive ability to understand all instructions and questionnaires in the study Willing and able to participate in the study and follow the protocol Individuals with lower limb loss, amputation or deficiency
None
No contact data.
1 Study Locations in 1 Countries
California
Össur Americas, Irvine, California, 92610, United States
Kurt N Gruben, Contact, + 1-800-233-6263, [email protected]
Recruiting