NCT05719935 · Extremity Medical
The KinematX Midcarpal Total Wrist Arthroplasty Registry
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- 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
- Loma Linda, California
- Tampa, Florida
- Indianapolis, Indiana
- New York, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 15, 2023 · Source of record for eligibility and locations