NCT06210620

Pro APP Prosthetic Outcome Registry

Prospective, Observational Registry to Collect Standard of Care Clinical Testing Data From Lower-limb Prosthesis Patients Via the PRO App.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Össur Iceland ehf · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 as a new fitting, alignment, or replacement of a previous prosthesis) at the investigational sites will be offered to provide data to the registry. Data collection will be a part of the standard of care and is entered by the participating prosthetists, physicians, physical therapists, or other designated staff during clinic/service visits. Data already entered into the PRO App system may also be collected into the registry if the participant consents. This registry will recruit patients who meet the inclusion criteria. Participation is fully voluntary. After the enrollment, all participants would be evaluated during follow-up visits as demanded by their standard of care. Exploratory analyses may be implemented, utilizing the already collected data, to investigate specific populations and their outcomes depending on the enrollment of said population groups. As an example; data will be collected from the registry to stratify two demographically matching groups of prosthetic users using a powered knee and a non-powered knee.

Conditions

• Amputation

Timeline

• Start date: 2024-01-01
• Primary completion: 2033-09-01
• Completion: 2033-09-01
• First posted: 2024-01-18
• Last updated: 2025-09-15

Locations

1 site across 1 country: United States