RECRUITING

The KinematX Midcarpal Total Wrist Arthroplasty Registry

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The KinematX Midcarpal Total Wrist Arthroplasty: A Multicenter Prospective Registry of Clinical and Patient-Reported Outcomes

Quick Facts

Study Start:2021-04-26
Study Completion:2035-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05719935

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * one of the following diagnoses and planned (or previously completed) total wrist arthroplasty with the KinematX total wrist:
  2. * osteoarthritis or post-traumatic arthritis
  3. * scapholunate advanced collapse (SLAC/SNAC wrist),
  4. * inflammatory arthritis (rheumatoid, psoriatic, other),
  5. * crystalline advanced collapse (SCAC),
  6. * STT advanced collapse (STTAC),
  7. * ulnar translocation,
  8. * Kienbӧck disease,
  9. * radial malunion
  1. * \<18 years of age
  2. * \>85 years of age
  3. * Prisoners
  4. * Children
  5. * Pregnant women
  6. * Contraindications to receiving the KinematX:
  7. * Local, distant or systematic acute or chronic soft tissue or bony infection
  8. * Physiologically or psychologically compromised patient
  9. * Active wrist synovitis or severe carpal bone erosion
  10. * Suspected or documented metal allergy or intolerance
  11. * Insufficient extensor tendons
  12. * Inadequate skin, bone, neural or vascular status
  13. * Severe carpal bone malalignment, displacement, absorption, neoplastic, or carpal bone pathology
  14. * Sepsis
  15. * Osteomyelitis
  16. * Uncontrolled/untreated osteoporosis or metabolic bone disease
  17. * Metabolic or endocrinologic bone disorders
  18. * Osteomalacia
  19. * Distant foci of infections which may spread to the implant site
  20. * Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram

Contacts and Locations

Study Contact

Brian Smekal
CONTACT
+1 952-836-5698
bsmekal@extremitymedical.com

Principal Investigator

Brian Smekal
STUDY_DIRECTOR
Extremity Medical

Study Locations (Sites)

Loma Linda University
Loma Linda, California, 92354
United States
Florida Orthopaedic Institute
Tampa, Florida, 33637
United States
Franciscan Health
Indianapolis, Indiana, 46237
United States
Hospital for Special Surgery
New York, New York, 10021
United States

Collaborators and Investigators

Sponsor: Extremity Medical

  • Brian Smekal, STUDY_DIRECTOR, Extremity Medical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-26
Study Completion Date2035-12

Study Record Updates

Study Start Date2021-04-26
Study Completion Date2035-12

Terms related to this study

Keywords Provided by Researchers

  • Total wrist replacement
  • Total wrist arthroplasty

Additional Relevant MeSH Terms

  • 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)