The KinematX Midcarpal Total Wrist Arthroplasty Registry

Part of paid clinical trials in Loma Linda, California.

Sponsor
Extremity Medical
Study ID
NCT05719935
Status
Recruiting
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Conditions

  • Carpal Tunnel Syndrome (CTS)
  • Inflammatory Arthritis
  • Kienbock's Disease of Adults
  • Osteoarthritis
  • Post Traumatic Arthritis
  • Radial Malunion
  • Scaphoid Non-union Advanced Collapse (SNAC)
  • Scaphoid, Trapezium, and Trapezoid Advanced Collapse (STTAC)
  • Scapholunate Advanced Collapse (SLAC)
  • Scapholunate Crystalline Advanced Collapse (SCAC)
  • Ulnar Translocation

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • KinematX total wrist arthroplasty system — DEVICE
    The KinematX total wrist implant is a joint metal/polymer semi-constrained cemented prosthesis that utilizes an articulation that mimics the midcarpal joint instead of the radiocarpal joint.

Study Details

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.

Key Dates

Start date
Apr 26, 2021
Status verified
Nov 2023
Primary completion
Dec 31, 2035
Completion
Dec 31, 2035

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: KinematX patients
    Patients undergoing total wrist replacement with the KinematX implant.

Primary Outcome Measure

Range of Motion (as assessed by physician) [ Time Frame: Up to 10 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Loma Linda UniversityLoma LindaCalifornia92354
Elisabeth Clarke
[email protected]
Barth Riedel, MD (PRINCIPAL_INVESTIGATOR)
Florida Orthopaedic InstituteTampaFlorida33637
Debbi Warren
[email protected]
Craig Dent
[email protected]
Alfred Hess, MD (PRINCIPAL_INVESTIGATOR)
Franciscan HealthIndianapolisIndiana46237
Stephanie Alford
[email protected]
Richard Makowiec, MD (PRINCIPAL_INVESTIGATOR)
Hospital for Special SurgeryNew YorkNew York10021
Benjamin Basseri
[email protected]
Scott Wolfe, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Loma Linda, CA

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By research site
Loma Linda University· Loma Linda, CAFlorida Orthopaedic Institute· Tampa, FLFranciscan Health· Indianapolis, INHospital for Special Surgery· New York, NY

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