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
Conditions
Keywords
Total wrist replacement, Total wrist arthroplasty
Brief summary
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.
Interventions
DEVICEKinematX 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.
Sponsors
Extremity Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Range of Motion (as assessed by physician) | Up to 10 years | Flexion, Extension, Ulnar, Radial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Pain Interference 8a | 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 |
| PROMIS Global 10 | 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 |
| Patient-Rated Wrist Evaluation Score (PRWE) | 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 |
| PROMIS Upper Extremity Physical Function 7a | 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. |
| Percentage of patients experiencing post-operative complications | 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) | 3 months, 6 months, yearly up to 10 years post-surgery | — |
| Grip and pinch strength (as assessed by physician) | 3months, 6 months, yearly up to 10 years post-surgery | Grip and pinch strength |
| Hospital for Special Surgery Wrist Surgery Expectations Survey | 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 |
Countries
United States
Contacts
Primary ContactBrian Smekal
Outcome results
None listed