Health TrialsbyHealthPanel

The KinematX Midcarpal Total Wrist Arthroplasty Registry

ConditionsScapholunate Advanced Collapse (SLAC)Scapholunate Crystalline Advanced Collapse (SCAC)Scaphoid, Trapezium, and Trapezoid Advanced Collapse (STTAC)Carpal Tunnel Syndrome (CTS)Kienbock's Disease of AdultsRadial MalunionUlnar TranslocationPost Traumatic ArthritisInflammatory ArthritisOsteoarthritisScaphoid Non-union Advanced Collapse (SNAC)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorExtremity Medical

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

osteoarthritis or post-traumatic arthritis

scapholunate advanced collapse (SLAC/SNAC wrist),

inflammatory arthritis (rheumatoid, psoriatic, other),

crystalline advanced collapse (SCAC),

Disqualifiers

<18 years of age

>85 years of age

Prisoners

Children

Trial population

Patients aged 18-85 with planned (or previously completed) total wrist arthroplasty with the KinematX total wrist are eligible for enrollment into this study

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: KinematX patients1 intervention

Trial outcomes

Primary outcomes

1

Range of Motion (as assessed by physician)

Flexion, Extension, Ulnar, Radial

Time frame
Up to 10 years

Secondary outcomes

1

PROMIS Upper Extremity Physical Function 7a

7 questions designed to understand the patient's physical function in the upper extremity specifically; population average t-score is 50, with a standard deviation of 10; higher scores are better.

Time frame
3 months, 6 months, yearly up to 10 years post-surgery
2

PROMIS Pain Interference 8a

8 questions designed to understand how any pain experienced interferes with the patient's day to day life; population average t-score is 50, with a standard deviation of 10; lower scores are better

Time frame
3 months, 6 months, yearly up to 10 years post-surgery
3

PROMIS Global 10

10 questions to assess the patient's global health with subscales for physical health and mental health; Physical health t-scores range from 16.2 to 67.7; Mental health t-scores range from 21.2 to 67.6; higher scores are better

Time frame
3 months, 6 months, yearly up to 10 years post-surgery
4

Patient-Rated Wrist Evaluation Score (PRWE)

15 questions that assess pain and function; total scores can range from 0-100; lower scores are better

Time frame
3 months, 6 months, yearly up to 10 years post-surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Extremity Medical

Lead sponsor

Source ClinicalTrials.gov
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