NCT06210620

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
89mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Jan 2024Sep 2033

Study Start

First participant enrolled

January 1, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2033

Last Updated

September 15, 2025

Status Verified

March 1, 2025

Enrollment Period

9.7 years

First QC Date

January 8, 2024

Last Update Submit

September 8, 2025

Conditions

Amputation

Keywords

Registry

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Provide data on device performance

    10 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient undergoing lower limb prosthetic treatment with their prescribed devices, such as a new fitting, alignment, or replacement of a previous prosthesis.

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Össur Americas

Irvine, California, 92610, United States

RECRUITING

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2024

First Posted

January 18, 2024

Study Start

January 1, 2024

Primary Completion (Estimated)

September 1, 2033

Study Completion (Estimated)

September 1, 2033

Last Updated

September 15, 2025

Record last verified: 2025-03

Locations

US(1)