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NCT05719935 | RECRUITING | Scapholunate Advanced Collapse (SLAC)

The KinematX Midcarpal Total Wrist Arthroplasty Registry
Sponsor:

Extremity Medical

Brief 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.

Condition or disease

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)

Intervention/treatment

KinematX total wrist arthroplasty system

Study Type : OBSERVATIONAL
Estimated Enrollment : 50 participants
Official Title : The KinematX Midcarpal Total Wrist Arthroplasty: A Multicenter Prospective Registry of Clinical and Patient-Reported Outcomes
Actual Study Start Date : 2021-04-26
Estimated Primary Completion Date : 2035-12
Estimated Study Completion Date : 2035-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
The KinematX Midcarpal Total Wrist Arthroplasty Registry

Location Details

NCT05719935

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Loma Linda University

Loma Linda, California, United States, 92354

RECRUITING

United States, Florida

Florida Orthopaedic Institute

Tampa, florida, United States, 33637

RECRUITING

United States, Indiana

Franciscan Health

Indianapolis, Indiana, United States, 46237

RECRUITING

United States, New York

Hospital for Special Surgery

New York, New York, United States, 10021