Actively Recruiting
The KinematX Midcarpal Total Wrist Arthroplasty Registry
Led by Extremity Medical · Updated on 2023-11-15
50
Participants Needed
4
Research Sites
761 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The KinematX Midcarpal Total Wrist Arthroplasty Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with osteoarthritis or post-traumatic arthritis
- Diagnosed with scapholunate advanced collapse (SLAC/SNAC wrist)
- Diagnosed with inflammatory arthritis (rheumatoid, psoriatic, or other types)
- Diagnosed with crystalline advanced collapse (SCAC)
- Diagnosed with STT advanced collapse (STTAC)
- Diagnosed with ulnar translocation
- Diagnosed with Kienb�e4ck disease
- Diagnosed with radial malunion
- Planned or previously completed total wrist arthroplasty with the KinematX total wrist implant
You will not qualify if you...
- Younger than 18 years old
- Older than 85 years old
- Prisoners
- Children
- Pregnant women
- Local, distant, or systemic acute or chronic soft tissue or bone infections
- Physiologically or psychologically compromised patients
- Active wrist synovitis or severe carpal bone erosion
- Suspected or documented metal allergy or intolerance
- Insufficient extensor tendons
- Inadequate skin, bone, nerve, or vascular status
- Severe carpal bone malalignment, displacement, absorption, neoplastic, or other carpal bone pathology
- Sepsis
- Osteomyelitis
- Uncontrolled or untreated osteoporosis or metabolic bone disease
- Metabolic or endocrine bone disorders
- Osteomalacia
- Distant infections that may spread to the implant site
- Rapid joint destruction, marked bone loss, or bone resorption visible on X-rays
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Loma Linda University
Loma Linda, California, United States, 92354
Actively Recruiting
2
Florida Orthopaedic Institute
Tampa, Florida, United States, 33637
Actively Recruiting
3
Franciscan Health
Indianapolis, Indiana, United States, 46237
Actively Recruiting
4
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
Research Team
B
Brian Smekal
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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