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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• one of the following diagnoses and planned (or previously completed) total wrist arthroplasty with the KinematX total wrist:

‣ osteoarthritis or post-traumatic arthritis

⁃ scapholunate advanced collapse (SLAC/SNAC wrist),

⁃ inflammatory arthritis (rheumatoid, psoriatic, other),

⁃ crystalline advanced collapse (SCAC),

⁃ STT advanced collapse (STTAC),

⁃ ulnar translocation,

⁃ Kienbӧck disease,

⁃ radial malunion

Locations
United States
California
Loma Linda University
RECRUITING
Loma Linda
Florida
Florida Orthopaedic Institute
RECRUITING
Tampa
Indiana
Franciscan Health
RECRUITING
Indianapolis
New York
Hospital for Special Surgery
RECRUITING
New York
Contact Information
Primary
Brian Smekal
bsmekal@extremitymedical.com
+1 952-836-5698
Time Frame
Start Date: 2021-04-26
Estimated Completion Date: 2035-12
Participants
Target number of participants: 50
Treatments
KinematX patients
Patients undergoing total wrist replacement with the KinematX implant.
Sponsors
Leads: Extremity Medical

This content was sourced from clinicaltrials.gov