No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 85
Sex
Any
Study type
Observational
Participants needed
50 (estimated)
Sponsor
Extremity Medical · Industry
Who this trial is looking for
This trial is looking for patients who need total wrist replacement surgery using the KinematX implant. Participants will be followed for up to 10 years to track their recovery and wrist function after the surgery.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with osteoarthritis
I have been diagnosed with scapholunate advanced collapse
I have been diagnosed with inflammatory arthritis
I have been diagnosed with Kienböck disease
I have been diagnosed with radial malunion
I have been diagnosed with ulnar translocation
I have been diagnosed with crystalline advanced collapse
I have been diagnosed with post-traumatic arthritis
You may not be able to join if
I am under 18 years old
I am over 85 years old
I am currently pregnant
I have an active wrist infection
I have a severe wrist injury that cannot be treated
I have a metal allergy
I have uncontrolled osteoporosis
I have a serious infection elsewhere in my body
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 pat…
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.
Trial Locations
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Eligibility Criteria
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,…
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
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