The KinematX Midcarpal Total Wrist Arthroplasty Registry

Recruiting

• Conditions: Scaphoid, Trapezium, and Trapezoid Advanced Collapse (STTAC); Kienbock's Disease of Adults; Scaphoid Non-union Advanced Collapse (SNAC); Scapholunate Advanced Collapse (SLAC); Ulnar Translocation; Post Traumatic Arthritis; Inflammatory Arthritis; Scapholunate Crystalline Advanced Collapse (SCAC); Carpal Tunnel Syndrome (CTS); Radial Malunion
• Interventions: Device: KinematX total wrist arthroplasty system

• Registration Number: NCT05719935
• Lead Sponsor: Extremity Medical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-26
• Study First Submitted: 2022-12-19
• Study First Submitted QC: 2023-01-30
• Study First Posted: 2023-02-09
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-15
• Primary Completion: 2035-12
• Study Completion: 2035-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
KinematX patients	KinematX total wrist arthroplasty system	Patients undergoing total wrist replacement with the KinematX implant.

Primary Outcome Measures

Name	Time	Method
Range of Motion (as assessed by physician)	Up to 10 years	Flexion, Extension, Ulnar, Radial

Secondary Outcome Measures

Name	Time	Method
PROMIS Upper Extremity Physical Function 7a	3 months, 6 months, yearly up to 10 years post-surgery	7 questions designed to understand the patient's physical function in the upper extremity specifically; population average t-score is 50, with a standard deviation of 10; higher scores are better.
PROMIS Pain Interference 8a	3 months, 6 months, yearly up to 10 years post-surgery	8 questions designed to understand how any pain experienced interferes with the patient's day to day life; population average t-score is 50, with a standard deviation of 10; lower scores are better
PROMIS Global 10	3 months, 6 months, yearly up to 10 years post-surgery	10 questions to assess the patient's global health with subscales for physical health and mental health; Physical health t-scores range from 16.2 to 67.7; Mental health t-scores range from 21.2 to 67.6; higher scores are better
Grip and pinch strength (as assessed by physician)	3months, 6 months, yearly up to 10 years post-surgery	Grip and pinch strength
Patient-Rated Wrist Evaluation Score (PRWE)	3 months, 6 months, yearly up to 10 years post-surgery	15 questions that assess pain and function; total scores can range from 0-100; lower scores are better
Hospital for Special Surgery Wrist Surgery Expectations Survey	Pre-operative and yearly up to 10 years post-surgery	22 questions that assess how the patient expects to benefit from the surgery and a corresponding post-operative instrument that asks about actual experience; score range from 22 to 110; lower scores are better
Percentage of patients experiencing post-operative complications	3 months, 6 months, yearly up to 10 years post-surgery
Percentage of patients requiring revision surgery for their implant (with or without implant replacement)	3 months, 6 months, yearly up to 10 years post-surgery

Trial Locations

Locations (4)

Loma Linda University; 🇺🇸 Loma Linda, California, United States

Franciscan Health; 🇺🇸 Indianapolis, Indiana, United States

Hospital for Special Surgery; 🇺🇸 New York, New York, United States

Florida Orthopaedic Institute; 🇺🇸 Tampa, Florida, United States