The KinematX Midcarpal Total Wrist Arthroplasty Registry

NCT05719935 | Recruiting FDA Device

• 1 other identifier: 112020-1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 4

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; Radial Malunion; Ulnar Translocation; Post Traumatic Arthritis; Inflammatory Arthritis; Osteoarthritis; Scaphoid Non-union Advanced Collapse (SNAC)

Keywords

Total wrist replacement; Total wrist arthroplasty

Outcome Measures

Primary Outcomes (1)

• Range of Motion (as assessed by physician)

  Flexion, Extension, Ulnar, Radial

  Up to 10 years

Secondary Outcomes (8)

• PROMIS Upper Extremity Physical Function 7a

  3 months, 6 months, yearly up to 10 years post-surgery

• PROMIS Pain Interference 8a

  3 months, 6 months, yearly up to 10 years post-surgery

• PROMIS Global 10

  3 months, 6 months, yearly up to 10 years post-surgery

• Patient-Rated Wrist Evaluation Score (PRWE)

  3 months, 6 months, yearly up to 10 years post-surgery

• Hospital for Special Surgery Wrist Surgery Expectations Survey

  Pre-operative and yearly up to 10 years post-surgery

Study Arms (1)

KinematX patients

Patients undergoing total wrist replacement with the KinematX implant.

Device: KinematX total wrist arthroplasty system

Interventions

KinematX total wrist arthroplasty system DEVICE

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.

KinematX patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Extremity Medical: lead

Study Sites (4)

Loma Linda University

Loma Linda, California, 92354, United States

RECRUITING

Florida Orthopaedic Institute

Tampa, Florida, 33637, United States

RECRUITING

Franciscan Health

Indianapolis, Indiana, 46237, United States

RECRUITING

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Arthritis; Osteoarthritis

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Brian Smekal

  Extremity Medical

  STUDY DIRECTOR

Central Study Contacts

Brian Smekal

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: February 9, 2023
• Study Start: April 26, 2021
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 1, 2035
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)