Recruiting

Observational Study

Sponsor:

Extremity Medical

Code:

NCT05719935

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

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

KinematX total wrist arthroplasty system

Study Details

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.

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

Study ID

NCT05719935

Start date

Apr 26, 2021

Status verified date

Nov, 2023

Completion date

Dec, 2035

Anticipated

Primary completion date

Dec, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

KinematX patients

Patients undergoing total wrist replacement with the KinematX implant.

Interventions

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.

Primary outcome measure

  • Range of Motion (as assessed by physician) [ Time Frame: Up to 10 years ]

Central Contacts and Locations

Central contacts

Brian Smekal

+1 952-836-5698bsmekal@extremitymedical.com

Locations

Loma Linda University

Recruiting

Loma Linda, California, United States, 92354

Contacts

Elisabeth Clarke

EAClarke@llu.edu

Principal Investigator:

Barth Riedel, MD

Florida Orthopaedic Institute

Recruiting

Tampa, Florida, United States, 33637

Contacts

Debbi Warren

dwarren@foreonline.org

Craig Dent

cdent@foreonline.org

Principal Investigator:

Alfred Hess, MD

Franciscan Health

Recruiting

Indianapolis, Indiana, United States, 46237

Contacts

Stephanie Alford

stephanie.alford@franciscanalliance.org

Principal Investigator:

Richard Makowiec, MD

Hospital for Special Surgery

Recruiting

New York, New York, United States, 10021

Contacts

Benjamin Basseri

basserib@hss.edu

Principal Investigator:

Scott Wolfe, MD

More Information

Sponsor

Extremity Medical

Last update posted

Nov 15, 2023

Last verified

Nov, 2023

Keywords

  • Total wrist replacement
  • Total wrist arthroplasty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Extremity Medical on 2023-11-15.