- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05719935
The KinematX Midcarpal Total Wrist Arthroplasty Registry
The KinematX Midcarpal Total Wrist Arthroplasty: A Multicenter Prospective Registry of Clinical and Patient-Reported Outcomes
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.
Study Overview
Status
Conditions
- Osteoarthritis
- Inflammatory Arthritis
- Carpal Tunnel Syndrome (CTS)
- Post Traumatic Arthritis
- Scapholunate Advanced Collapse (SLAC)
- Scapholunate Crystalline Advanced Collapse (SCAC)
- Scaphoid, Trapezium, and Trapezoid Advanced Collapse (STTAC)
- Kienbock's Disease of Adults
- Radial Malunion
- Ulnar Translocation
- Scaphoid Non-union Advanced Collapse (SNAC)
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Brian Smekal
- Phone Number: +1 952-836-5698
- Email: bsmekal@extremitymedical.com
Study Locations
-
-
California
-
Loma Linda, California, United States, 92354
- Recruiting
- Loma Linda University
-
Principal Investigator:
- Barth Riedel, MD
-
Contact:
- Elisabeth Clarke
- Email: EAClarke@llu.edu
-
-
Florida
-
Tampa, Florida, United States, 33637
- Recruiting
- Florida Orthopaedic Institute
-
Principal Investigator:
- Alfred Hess, MD
-
Contact:
- Debbi Warren
- Email: dwarren@foreonline.org
-
Contact:
- Craig Dent
- Email: cdent@foreonline.org
-
-
Indiana
-
Indianapolis, Indiana, United States, 46237
- Recruiting
- Franciscan Health
-
Contact:
- Stephanie Alford
- Email: stephanie.alford@franciscanalliance.org
-
Principal Investigator:
- Richard Makowiec, MD
-
-
New York
-
New York, New York, United States, 10021
- Recruiting
- Hospital for Special Surgery
-
Contact:
- Benjamin Basseri
- Email: basserib@hss.edu
-
Principal Investigator:
- Scott Wolfe, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
KinematX patients
Patients undergoing total wrist replacement with the KinematX implant.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Range of Motion (as assessed by physician)
Time Frame: Up to 10 years
|
Flexion, Extension, Ulnar, Radial
|
Up to 10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PROMIS Upper Extremity Physical Function 7a
Time Frame: 3 months, 6 months, yearly up to 10 years post-surgery
|
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.
|
3 months, 6 months, yearly up to 10 years post-surgery
|
PROMIS Pain Interference 8a
Time Frame: 3 months, 6 months, yearly up to 10 years post-surgery
|
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
|
3 months, 6 months, yearly up to 10 years post-surgery
|
PROMIS Global 10
Time Frame: 3 months, 6 months, yearly up to 10 years post-surgery
|
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
|
3 months, 6 months, yearly up to 10 years post-surgery
|
Patient-Rated Wrist Evaluation Score (PRWE)
Time Frame: 3 months, 6 months, yearly up to 10 years post-surgery
|
15 questions that assess pain and function; total scores can range from 0-100; lower scores are better
|
3 months, 6 months, yearly up to 10 years post-surgery
|
Hospital for Special Surgery Wrist Surgery Expectations Survey
Time Frame: Pre-operative and yearly up to 10 years post-surgery
|
22 questions that assess how the patient expects to benefit from the surgery and a corresponding post-operative instrument that asks about actual experience; score range from 22 to 110; lower scores are better
|
Pre-operative and yearly up to 10 years post-surgery
|
Percentage of patients experiencing post-operative complications
Time Frame: 3 months, 6 months, yearly up to 10 years post-surgery
|
3 months, 6 months, yearly up to 10 years post-surgery
|
|
Percentage of patients requiring revision surgery for their implant (with or without implant replacement)
Time Frame: 3 months, 6 months, yearly up to 10 years post-surgery
|
3 months, 6 months, yearly up to 10 years post-surgery
|
|
Grip and pinch strength (as assessed by physician)
Time Frame: 3months, 6 months, yearly up to 10 years post-surgery
|
Grip and pinch strength
|
3months, 6 months, yearly up to 10 years post-surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Brian Smekal, Extremity Medical
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Necrosis
- Nervous System Diseases
- Wounds and Injuries
- Joint Diseases
- Musculoskeletal Diseases
- Neuromuscular Diseases
- Mononeuropathies
- Peripheral Nervous System Diseases
- Median Neuropathy
- Nerve Compression Syndromes
- Cumulative Trauma Disorders
- Sprains and Strains
- Bone Diseases
- Arthritis
- Carpal Tunnel Syndrome
- Shock
- Osteonecrosis
Other Study ID Numbers
- 112020-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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