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NCT05773352 · ClinicalTrials.gov registry record
Perform® Humeral System - Fracture Study (PFX)
A clinical trial of Traumatic Arthritis and Traumatic Arthropathy of Shoulder, sponsored by Stryker Trauma and Extremities.
- Active
- Registry status
- 125
- Enrollment target
- 9
- Study locations
NCT05773352: Active study of Traumatic Arthritis and Traumatic Arthropathy of Shoulder, sponsored by Stryker Trauma and Extremities.
NCT05773352 is a study of Traumatic Arthritis and Traumatic Arthropathy of Shoulder that is active but no longer recruiting, run by Stryker Trauma and Extremities. The registered enrollment target is 125 participants, below the 396-participant average among 11 other Traumatic Arthritis trials with a reported enrollment target (68% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05773352, a study of Traumatic Arthritis and Traumatic Arthropathy of Shoulder, is active but no longer recruiting, sponsored by Stryker Trauma and Extremities.
- ACTIVE NOT RECRUITING
- Registry status
- 125 participants
- Enrollment target
- 9
- Study locations
Study Summary
This study is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF), which is designed to collect safety and performance data on commercially available Perform® Fracture. Data collected from this study will be used for purposes, including but not limited to, PMS, peer-reviewed publications, education materials, future regulatory submissions, and/or product development.
Primary Outcome
11 items with total score reported out of 100 measuring pain and activity of patient's evaluated shoulder where lower scores indicate more pain and less function
Conditions Studied
Interventions
- DEVICE Tornier Perform® Humeral System - Fracture
Study Locations (9)
California
- Eisenhower Health Desert Orthopedic Center - Rancho Mirage
- California Pacific Orthopaedics - San Francisco
Arizona
- More Foundation - Phoenix
Arkansas
- University of Arkansas Medical Sciences - Little Rock
Florida
- The Center for Bone and Joint Disease - Hudson
Illinois
- Loyola University Chicago - Maywood
Missouri
- Washington University - St Louis
Tennessee
- Tennessee Orthopaedic Alliance - Columbia
Texas
- University of Texas/UT Health - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2023-08-31 |
| Est. Completion | 2033-09-01 |
What the registry record for NCT05773352 still lists
NCT05773352 is an observational study that tracks outcomes without assigning an intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 396-participant average among 11 other Traumatic Arthritis trials with a reported enrollment target (68% lower).
The record links to 4 conditions, with Traumatic Arthritis appearing as the primary indexed condition, and to 1 intervention - of which Tornier Perform® Humeral System - Fracture is the first listed.
NCT05773352 lists 9 locations in 8 states (California, Arizona, Arkansas).
Frequently Asked Questions
What is clinical trial NCT05773352 about?
NCT05773352 is a clinical study titled "Perform® Humeral System - Fracture Study (PFX)". This study is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF), which is designed to collect safety and performance data on commercially available Perform® Fracture. Data collected from this study will be used for purposes...
What is the current status of trial NCT05773352?
This trial is currently active not recruiting. The enrollment target is 125 participants. The study started on 2023-08-31. Estimated completion is 2033-09-01.
What conditions does trial NCT05773352 study?
This clinical trial studies the following conditions: Traumatic Arthritis, Traumatic Arthropathy of Shoulder, Fracture Humerus, Revision of Other Devices if Sufficient Bone Stock Remains.
What interventions are being tested in trial NCT05773352?
The interventions under investigation include: Tornier Perform® Humeral System - Fracture (DEVICE).
Who is sponsoring clinical trial NCT05773352?
This trial is sponsored by Stryker Trauma and Extremities, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05773352 being conducted?
This trial has 9 study locations across Arizona, Arkansas, California, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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125 10th of 11 higher than 2 of 11 other Traumatic Arthritis trials
participants (enrollment target), bucketed by value
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