KinematX Midcarpal Total Wrist Arthroplasty Registry

This study is looking at how well the KinematX total wrist arthroplasty system works for people with certain wrist conditions like osteoarthritis, post-traumatic arthritis, or scapholunate advanced collapse (SLAC). The KinematX implant is a joint replacement that mimics the midcarpal joint in your wrist. Researchers want to understand your wrist's range of motion (how much you can move it) and your own reports on how your wrist is doing after surgery. They will follow participants for up to 10 years to see these long-term results. This study is currently recruiting about 50 adults between 18 and 85 years old who are planning to have or have already had this specific wrist replacement.

Study design
This is an observational study, meaning researchers will watch and collect information from about 50 participants over time. It is not a randomized study where you would be assigned to different treatment groups.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 10 years after their surgery to assess their wrist's range of motion and their reported outcomes.

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NCT05719935

The KinematX Midcarpal Total Wrist Arthroplasty Registry

Recruiting
Not specifiedAges 18–85Observational
Extremity Medical
~50 participants
Updated 2023-11-15 on ClinicalTrials.gov
What's tested:KinematX total wrist arthroplasty system

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Range of Motion (as assessed by physician)
Measured over Up to 10 years
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)
4 sites across 4 states
California1
Florida1
Indiana1
New York1
  • Brian Smekal · STUDY_DIRECTOR · Extremity Medical

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Eligibility criteria

Inclusion

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

\<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
  • Range of Motion (as assessed by physician)Up to 10 years

    Flexion, Extension, Ulnar, Radial