The KinematX Midcarpal Total Wrist Arthroplasty Registry

The KinematX Midcarpal Total Wrist Arthroplasty: A Multicenter Prospective Registry of Clinical and Patient-Reported Outcomes

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Brian Smekal; Phone Number: +1 952-836-5698; Email: bsmekal@extremitymedical.com

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Recruiting
      • Loma Linda University
      • Principal Investigator: Barth Riedel, MD
      • Contact: Elisabeth Clarke; Email: EAClarke@llu.edu
  • Florida
    • Tampa, Florida, United States, 33637
      • Recruiting
      • Florida Orthopaedic Institute
      • Principal Investigator: Alfred Hess, MD
      • Contact: Debbi Warren; Email: dwarren@foreonline.org
      • Contact: Craig Dent; Email: cdent@foreonline.org
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Recruiting
      • Franciscan Health
      • Contact: Stephanie Alford; Email: stephanie.alford@franciscanalliance.org
      • Principal Investigator: Richard Makowiec, MD
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Hospital For Special Surgery
      • Contact: Benjamin Basseri; Email: basserib@hss.edu
      • Principal Investigator: Scott Wolfe, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
KinematX patients; Patients undergoing total wrist replacement with the KinematX implant.	Device: KinematX total wrist arthroplasty system; The KinematX total wrist implant is a joint metal/polymer semi-constrained cemented prosthesis that utilizes an articulation that mimics the midcarpal joint instead of the radiocarpal joint.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of Motion (as assessed by physician)	Flexion, Extension, Ulnar, Radial	Up to 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Upper Extremity Physical Function 7a	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.	3 months, 6 months, yearly up to 10 years post-surgery
PROMIS Pain Interference 8a	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	3 months, 6 months, yearly up to 10 years post-surgery
PROMIS Global 10	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	3 months, 6 months, yearly up to 10 years post-surgery
Patient-Rated Wrist Evaluation Score (PRWE)	15 questions that assess pain and function; total scores can range from 0-100; lower scores are better	3 months, 6 months, yearly up to 10 years post-surgery
Hospital for Special Surgery Wrist Surgery Expectations Survey	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	Pre-operative and yearly up to 10 years post-surgery
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
Grip and pinch strength (as assessed by physician)	Grip and pinch strength	3months, 6 months, yearly up to 10 years post-surgery

Collaborators and Investigators

• Sponsor: Extremity Medical
• Investigators: Study Director: Brian Smekal, Extremity Medical

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2021
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 1, 2035

Study Registration Dates

• First Submitted: December 19, 2022
• First Submitted That Met QC Criteria: January 30, 2023
• First Posted (Actual): February 9, 2023

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Total wrist replacement; Total wrist arthroplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Nervous System Diseases; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Bone Diseases; Arthritis; Carpal Tunnel Syndrome; Shock; Osteonecrosis
• Other Study ID Numbers: 112020-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No