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The KinematX Midcarpal Total Wrist Arthroplasty Registry

NCT05719935 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-11-15

No results posted yet for this 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

  • Scapholunate Advanced Collapse (SLAC)
  • Scapholunate Crystalline Advanced Collapse (SCAC)
  • Scaphoid, Trapezium, and Trapezoid Advanced Collapse (STTAC)
  • Carpal Tunnel Syndrome (CTS)
  • Kienbock's Disease of Adults
  • Radial Malunion
  • Ulnar Translocation
  • Post Traumatic Arthritis
  • Inflammatory Arthritis
  • Osteoarthritis
  • Scaphoid Non-union Advanced Collapse (SNAC)

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.

Sponsors & Collaborators

  • Extremity Medical

    lead INDUSTRY

Principal Investigators

  • Brian Smekal · Extremity Medical

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-26
Primary Completion
2035-12-31
Completion
2035-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05719935 on ClinicalTrials.gov