The KinematX Midcarpal Total Wrist Arthroplasty Registry

Last updated: November 13, 2023
Sponsor: Extremity Medical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Carpal Tunnel Syndrome

Low Blood Pressure (Hypotension)

Treatment

KinematX total wrist arthroplasty system

Clinical Study ID

NCT05719935
112020-1
  • Ages 18-85
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • one of the following diagnoses and planned (or previously completed) total wristarthroplasty 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

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 carpalbone 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 onroentgenogram

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: KinematX total wrist arthroplasty system
Phase:
Study Start date:
April 26, 2021
Estimated Completion Date:
December 31, 2035

Connect with a study center

  • Loma Linda University

    Loma Linda, California 92354
    United States

    Active - Recruiting

  • Florida Orthopaedic Institute

    Tampa, Florida 33637
    United States

    Active - Recruiting

  • Franciscan Health

    Indianapolis, Indiana 46237
    United States

    Active - Recruiting

  • Indiana Hand to Shoulder Center

    Indianapolis, Indiana 46260
    United States

    Active - Recruiting

  • Hospital for Special Surgery

    New York, New York 10021
    United States

    Active - Recruiting

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