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NCT05719935 · ClinicalTrials.gov registry record
The KinematX Midcarpal Total Wrist Arthroplasty Registry
A clinical trial of Osteoarthritis and Post Traumatic Arthritis, sponsored by Extremity Medical.
- Recruiting
- Registry status
- 50
- Enrollment target
- 4
- Study locations
NCT05719935 is a study of Osteoarthritis and Post Traumatic Arthritis that is actively recruiting participants, run by Extremity Medical. The registered enrollment target is 50 participants, below the 817-participant average among 135 other Osteoarthritis trials with a reported enrollment target (94% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT05719935, a study of Osteoarthritis and Post Traumatic Arthritis, is actively recruiting participants, sponsored by Extremity Medical.
- RECRUITING
- Registry status
- 50 participants
- Enrollment target
- 4
- Study locations
Study Summary
The goal of this observational study is to learn about functional and patient reported outcomes in patient undergoing total wrist replacement with the KinematX total wrist replacement study. The main questions it aims to answer are: * What is the range of motion (flexion, extension, radial, ulnar, grip and pinch strength) at 3-, 6-, and 12-months after surgery and yearly up to 10 years among patients having total wrist replacement with the KinematX implant. * What are the patient reported outcomes (PROMIS, PRWE, HSS wrist expectations) at 3-, 6-, and 12-months after surgery and yearly up to 10 years among patients having total wrist replacement with the KinematX implant. * How do range of motion and patient reported outcomes change over the 10 years after total wrist replacement surgery? Participants will be followed according to standard of care and preoperative and post-operative information for up to 10 years after surgery will be collected and entered into an electronic data base. Patients are eligible to enroll into the registry before or after they have had their wrist replacement surgery.
Conditions Studied
Interventions
- DEVICE KinematX total wrist arthroplasty system
Study Locations (4)
California
- Loma Linda University - Loma Linda
Florida
- Florida Orthopaedic Institute - Tampa
Indiana
- Franciscan Health - Indianapolis
New York
- Hospital for Special Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2021-04-26 |
| Est. Completion | 2035-12 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05719935
The ClinicalTrials.gov registry entry for NCT05719935 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 817-participant average among 135 other Osteoarthritis trials with a reported enrollment target (94% lower). The listed sponsor is Extremity Medical, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Osteoarthritis appearing as the primary indexed condition, and to 1 intervention - of which KinematX total wrist arthroplasty system is the first listed.
NCT05719935 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, Florida, Indiana.
Frequently Asked Questions
What is clinical trial NCT05719935 about?
NCT05719935 is a clinical study titled "The KinematX Midcarpal Total Wrist Arthroplasty Registry". The goal of this observational study is to learn about functional and patient reported outcomes in patient undergoing total wrist replacement with the KinematX total wrist replacement study. The main questions it aims to answer are: * What is the range of motion (flexion, extension, radial, ulnar,...
What is the current status of trial NCT05719935?
This trial is currently recruiting. The enrollment target is 50 participants. The study started on 2021-04-26. Estimated completion is 2035-12.
What conditions does trial NCT05719935 study?
This clinical trial studies the following conditions: Osteoarthritis, Post Traumatic Arthritis, Inflammatory Arthritis, Carpal Tunnel Syndrome (CTS), Scapholunate Advanced Collapse (SLAC).
What interventions are being tested in trial NCT05719935?
The interventions under investigation include: KinematX total wrist arthroplasty system (DEVICE).
Who is sponsoring clinical trial NCT05719935?
This trial is sponsored by Extremity Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05719935 being conducted?
This trial has 4 study locations across California, Florida, Indiana, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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