The KinematX Midcarpal Total Wrist Arthroplasty Registry
Purpose
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)
Eligibility
- Eligible Ages
- Between 18 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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, - KienbÓ§ck 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
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| KinematX patients | Patients undergoing total wrist replacement with the KinematX implant. |
|
Recruiting Locations
Indianapolis, Indiana 46237
More Details
- Status
- Recruiting
- Sponsor
- Extremity Medical