RecruitingNot Applicable

The KinematX Midcarpal Total Wrist Arthroplasty Registry

United States50 participantsStarted 2021-04-26

Plain-language summary

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

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Range of Motion (as assessed by physician)

Timeframe: Up to 10 years

Trial details

NCT IDNCT05719935

SponsorExtremity Medical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2035-12

Contact for this trial

Brian Smekal

+1 952-836-5698 bsmekal@extremitymedical.com

View on ClinicalTrials.gov More Scapholunate Advanced Collapse (SLAC) trials