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The KinematX Midcarpal Total Wrist Arthroplasty Registry

RECRUITINGSponsored by Extremity Medical
Actively Recruiting
SponsorExtremity Medical
Started2021-04-26
Est. completion2035-12
Eligibility
Age18 Years – 85 Years
Healthy vol.Accepted
Locations4 sites

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.

Eligibility

Age: 18 Years – 85 YearsHealthy volunteers accepted
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

Conditions12

ArthritisCarpal Tunnel Syndrome (CTS)Inflammatory ArthritisKienbock's Disease of AdultsOsteoarthritisPost Traumatic ArthritisRadial MalunionScaphoid Non-union Advanced Collapse (SNAC)Scaphoid, Trapezium, and Trapezoid Advanced Collapse (STTAC)Scapholunate Advanced Collapse (SLAC)

Locations4 sites

California

1 site
Loma Linda University
Loma Linda, California, 92354
Elisabeth ClarkeEAClarke@llu.edu

Florida

1 site
Florida Orthopaedic Institute
Tampa, Florida, 33637

Indiana

1 site
Franciscan Health
Indianapolis, Indiana, 46237

New York

1 site
Hospital for Special Surgery
New York, New York, 10021
Benjamin Basseribasserib@hss.edu

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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