Actively Recruiting
The KinematX Midcarpal Total Wrist Arthroplasty Registry: A Prospective Study of Clinical and Patient-Reported Outcomes
Led by Extremity Medical · Updated on 2023-11-15
50
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying functional and patient-reported outcomes in people undergoing total wrist replacement surgery using the KinematX total wrist implant. This observational study aims to understand the range of motion and strength, as well as patient feedback on wrist function and expectations, at various time points from 3 months up to 10 years after surgery. The study focuses on patients with wrist conditions like osteoarthritis, inflammatory arthritis, and several types of wrist collapse or injury. Participants receive the KinematX total wrist implant, which is a metal and polymer device designed to mimic the midcarpal joint's movement. The study includes patients who have planned or already undergone total wrist replacement with this device. Follow-up occurs at 3, 6, and 12 months post-surgery, then yearly for up to 10 years to gather long-term data on wrist movement, grip and pinch strength, and patient-reported measures. During the study, participants will have their wrist range of motion and strength assessed by physicians, and they will complete questionnaires about their wrist function and pain at scheduled intervals. Data on complications and any revision surgeries will also be collected. All information is entered into an electronic database to track changes and outcomes over the 10-year period, with participants followed according to routine medical care.
CONDITIONS
Brief Title
The KinematX Midcarpal Total Wrist Arthroplasty Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 85 years
- Diagnosed with osteoarthritis, post-traumatic arthritis, inflammatory arthritis (rheumatoid, psoriatic, or other), or wrist collapse conditions including SLAC, SNAC, SCAC, STTAC
- Planned or previously completed total wrist replacement surgery using the KinematX implant
You will not qualify if you...
- Younger than 18 years or older than 85 years
- Prisoners or children
- Pregnant women
- Local, distant, or systemic acute or chronic soft tissue or bone infections
- Physiologically or psychologically compromised patients
- Active wrist synovitis or severe carpal bone erosion
- Metal allergy or intolerance
- Insufficient extensor tendons
- Inadequate skin, bone, nerve, or blood vessel status
- Severe carpal bone malalignment, displacement, absorption, neoplastic, or other bone pathology
- Sepsis or osteomyelitis
- Uncontrolled or untreated osteoporosis or metabolic bone disease
- Other metabolic or endocrine bone disorders including osteomalacia
- Distant infections that could spread to the implant site
- Rapid joint destruction or marked bone loss visible on x-rays
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - Up to 1 week or until discharge
Participants undergo total wrist replacement surgery with the KinematX implant and receive immediate post-operative care.
1 surgical visit and post-operative hospital stay
Duration - Up to 10 years post-surgery
Participants are followed up to assess clinical and patient-reported outcomes including range of motion, pain, function, complications, and implant status.
Visits at 3 months, 6 months, and yearly up to 10 years post-surgery
Trial Site Locations
Total: 4 locations
1
Loma Linda University
Loma Linda, California, United States, 92354
Actively Recruiting
2
Florida Orthopaedic Institute
Tampa, Florida, United States, 33637
Actively Recruiting
3
Franciscan Health
Indianapolis, Indiana, United States, 46237
Actively Recruiting
4
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
Research Team
B
Brian Smekal
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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