Clinical trial NCT05719935: The KinematX Midcarpal Total Wrist Arthroplasty Registry
Official title: The KinematX Midcarpal Total Wrist Arthroplasty: A Multicenter Prospective Registry of Clinical and Patient-Reported Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
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)
Keywords: Total wrist replacement
Total wrist arthroplasty
Lead sponsor: Extremity Medical
Sponsor class: INDUSTRY
First posted: 2023-02-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18-85 with planned (or previously completed) total wrist arthroplasty with the KinematX total wrist are eligible for enrollment into this study

Brief 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.


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,
  * 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

Primary outcomes:
measure: Range of Motion (as assessed by physician)
timeFrame: Up to 10 years
Secondary outcomes:
measure: PROMIS Upper Extremity Physical Function 7a
timeFrame: 3 months, 6 months, yearly up to 10 years post-surgery
measure: PROMIS Pain Interference 8a
timeFrame: 3 months, 6 months, yearly up to 10 years post-surgery
measure: PROMIS Global 10
timeFrame: 3 months, 6 months, yearly up to 10 years post-surgery
measure: Patient-Rated Wrist Evaluation Score (PRWE)
timeFrame: 3 months, 6 months, yearly up to 10 years post-surgery
measure: Hospital for Special Surgery Wrist Surgery Expectations Survey
timeFrame: Pre-operative and yearly up to 10 years post-surgery
measure: Percentage of patients experiencing post-operative complications
timeFrame: 3 months, 6 months, yearly up to 10 years post-surgery
measure: Percentage of patients requiring revision surgery for their implant (with or without implant replacement)
timeFrame: 3 months, 6 months, yearly up to 10 years post-surgery
measure: Grip and pinch strength (as assessed by physician)
timeFrame: 3months, 6 months, yearly up to 10 years post-surgery
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Tampa
country: United States
facility: Florida Orthopaedic Institute
state: Florida
city: Indianapolis
country: United States
facility: Franciscan Health
state: Indiana
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Extremity Medical
name: Brian Smekal
role: STUDY_DIRECTOR
References: