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RECRUITING
NCT05719935

The KinematX Midcarpal Total Wrist Arthroplasty Registry

Sponsor: Extremity Medical

View on ClinicalTrials.gov

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.

Official title: The KinematX Midcarpal Total Wrist Arthroplasty: A Multicenter Prospective Registry of Clinical and Patient-Reported Outcomes

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2021-04-26

Completion Date

2035-12

Last Updated

2023-11-15

Healthy Volunteers

No

Interventions

DEVICE

KinematX total wrist arthroplasty system

The KinematX total wrist implant is a joint metal/polymer semi-constrained cemented prosthesis that utilizes an articulation that mimics the midcarpal joint instead of the radiocarpal joint.

Locations (4)

Loma Linda University

Loma Linda, California, United States

Florida Orthopaedic Institute

Tampa, Florida, United States

Franciscan Health

Indianapolis, Indiana, United States

Hospital for Special Surgery

New York, New York, United States