Observational study on total wrist replacement outcomes with KinematX implant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the functional and patient-reported outcomes of individuals undergoing total wrist replacement using the KinematX total wrist arthroplasty system. Participants will be monitored for a range of motion, grip and pinch strength, and various patient-reported outcomes at multiple time points, including 3, 6, and 12 months post-surgery, and annually for up to 10 years. The study will collect preoperative and postoperative data to assess changes over time and determine the effectiveness of the KinematX implant in improving wrist function.

Why it matters

Who can join: the full rules

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

Where it's running

• Loma Linda University
  Loma Linda, California, United States Recruiting
• Florida Orthopaedic Institute
  Tampa, Florida, United States Recruiting
• Franciscan Health
  Indianapolis, Indiana, United States Recruiting
• Hospital for Special Surgery
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Brian Smekal
• Email: bsmekal@extremitymedical.com
• Phone: +1 952-836-5698

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.