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Recruiting NCT05719935

The KinematX Midcarpal Total Wrist Arthroplasty Registry

— Observational Scapholunate Advanced Collapse (SLAC) Scapholunate Crystalline Advanced Collapse (SCAC) Scaphoid, Trapezium, and Trapezoid Advanced Collapse (STTAC) Carpal Tunnel Syndrome (CTS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KinematX total wrist arthroplasty system.
Who it may be relevant to
Registry conditions: Scapholunate Advanced Collapse (SLAC), Scapholunate Crystalline Advanced Collapse (SCAC), Scaphoid, Trapezium, and Trapezoid Advanced Collapse (STTAC), Carpal Tunnel Syndrome (CTS). Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Range of Motion (as assessed by physician) [Time frame: Up to 10 years]
Secondary outcome measures (8)
  • PROMIS Upper Extremity Physical Function 7a [Time frame: 3 months, 6 months, yearly up to 10 years post-surgery]
  • PROMIS Pain Interference 8a [Time frame: 3 months, 6 months, yearly up to 10 years post-surgery]
  • PROMIS Global 10 [Time frame: 3 months, 6 months, yearly up to 10 years post-surgery]
  • Patient-Rated Wrist Evaluation Score (PRWE) [Time frame: 3 months, 6 months, yearly up to 10 years post-surgery]
  • Hospital for Special Surgery Wrist Surgery Expectations Survey [Time frame: Pre-operative and yearly up to 10 years post-surgery]
  • Percentage of patients experiencing post-operative complications [Time frame: 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) [Time frame: 3 months, 6 months, yearly up to 10 years post-surgery]
  • Grip and pinch strength (as assessed by physician) [Time frame: 3months, 6 months, yearly up to 10 years post-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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 4 centers
  • Loma Linda University — Loma Linda
  • Florida Orthopaedic Institute — Tampa
  • Franciscan Health — Indianapolis
  • Hospital for Special Surgery — New York

Identifiers

NCT: NCT05719935 · 112020-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗