Taking people in United StatesNo phase

The KinematX Midcarpal Total Wrist Arthroplasty Registry

Key facts

Who runs it: Extremity Medical
Where: Indianapolis, Loma Linda, New York, and Tampa, United StatesSee the 4 sites
Trial code: NCT05719935
Status: Recruiting
People taking part: 50 people, planned
Started: 26 Apr 2021
Expected to end: Dec 2035
Type of study: Observational
Treatments tested: KinematX total wrist arthroplasty system
Record updated: 15 November 2023

Who can take part

Age: 18 years to 85 years
Sex: Women and men
Healthy volunteers: Cannot take part

The registry criteria, word for word

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Who can take part

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

Who cannot take part

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
<18 years of age
>85 years of age
Prisoners
Children
Pregnant women

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 85 years old?

Where in United States

Franciscan HealthIndianapolis, United StatesContact: Stephanie AlfordTaking people
Loma Linda UniversityLoma Linda, United StatesContact: Elisabeth ClarkeTaking people
Hospital for Special SurgeryNew York, United StatesContact: Benjamin BasseriTaking people
Florida Orthopaedic InstituteTampa, United StatesContact: Debbi WarrenTaking people

About the trial

What the trial wants to find out

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.

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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.