The KinematX Midcarpal Total Wrist Arthroplasty Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-26

Study Completion Date

2035-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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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)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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KinematX patients

Patients undergoing total wrist replacement with the KinematX implant.

KinematX total wrist arthroplasty system

Intervention Type 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.

Interventions

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KinematX total wrist arthroplasty system

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No