Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-24 @ 10:21 PM
NCT ID:
NCT05719935
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, other),
* crystalline advanced collapse (SCAC),
* STT advanced collapse (STTAC),
* ulnar translocation,
* KienbÓ§ck 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05719935
Study Brief:
Protocol Section:
NCT05719935