Trials / Recruiting
RecruitingNCT05719935
The KinematX Midcarpal Total Wrist Arthroplasty Registry
The KinematX Midcarpal Total Wrist Arthroplasty: A Multicenter Prospective Registry of Clinical and Patient-Reported Outcomes
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (estimated)
- Sponsor
- Extremity Medical · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- 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)
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
Timeline
- Start date
- 2021-04-26
- Primary completion
- 2035-12-01
- Completion
- 2035-12-01
- First posted
- 2023-02-09
- Last updated
- 2023-11-15
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05719935. Inclusion in this directory is not an endorsement.