The KinematX Midcarpal Total Wrist Arthroplasty Registry
Recruiting now
Conditions studied: 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)
In brief
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.
Key facts
- Study ID
- NCT05719935
- Run by
- Extremity Medical
- People needed
- 50
- Starts
- 2021-04-26
- Expected to finish
- 2035-12-01
- Last updated by the study team
- 2023-11-15
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- <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
Where it is running
- Loma Linda University — Loma Linda, California, United States (enrolling)
- Florida Orthopaedic Institute — Tampa, Florida, United States (enrolling)
- Franciscan Health — Indianapolis, Indiana, United States (enrolling)
- Hospital for Special Surgery — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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