The KinematX Midcarpal Total Wrist Arthroplasty Registry

N/ARecruitingNCT05719935

Extremity Medical50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Scapholunate Advanced Collapse (SLAC)Scapholunate Crystalline Advanced Collapse (SCAC)Scaphoid, Trapezium, and Trapezoid Advanced Collapse (STTAC)Carpal Tunnel Syndrome (CTS)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * \<18 years of age * \>85 years of age * Prisoners * Children * Pregnant women * Contraindications to receiving the KinematX: * Local, distant or systematic acute or chronic soft tissue or bony infection * Physiologically or psychologically compromised patient * Active wrist synovitis or severe carpal bone erosion * Suspected or documented metal allergy or intolerance * Insufficient extensor tendons * Inadequate skin, bone, neural or vascular status * Severe carpal bone malalignment, displacement, absorption, neoplastic, or carpal bone pathology * Sepsis * Osteomyelitis * Uncontrolled/untreated osteoporosis or metabolic bone disease * Metabolic or endocrinologic bone disorders * Osteomalacia * Distant foci of infections which may spread to the implant site * Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram

Locations (4)

Loma Linda University

Loma Linda, California, United States

RECRUITING

Florida Orthopaedic Institute

Tampa, Florida, United States

RECRUITING

Franciscan Health

Indianapolis, Indiana, United States

RECRUITING

Hospital for Special Surgery

New York, New York, United States

RECRUITING

Outcomes

Primary Outcomes

Range of Motion (as assessed by physician)

Flexion, Extension, Ulnar, Radial

Time frame: Up to 10 years

Secondary Outcomes

PROMIS Upper Extremity Physical Function 7a

7 questions designed to understand the patient's physical function in the upper extremity specifically; population average t-score is 50, with a standard deviation of 10; higher scores are better.