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NCT Number: NCT05719935

The KinematX Midcarpal Total Wrist Arthroplasty Registry

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.

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Key information

Conditions

Scapholunate Advanced Collapse (SLAC) Arthritis Carpal Tunnel Syndrome Carpal Tunnel Syndrome (CTS) Cumulative Trauma Disorders Inflammatory Arthritis Joint Diseases Kienbock's Disease of Adults Median Neuropathy Mononeuropathies Musculoskeletal Diseases Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Osteoarthritis Peripheral Nervous System Diseases Post Traumatic Arthritis Radial Malunion Rheumatic Diseases Scaphoid Non-union Advanced Collapse (SNAC) Scaphoid, Trapezium, and Trapezoid Advanced Collapse (STTAC) Scapholunate Crystalline Advanced Collapse (SCAC) Sprains and Strains Ulnar Translocation Wounds and Injuries

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Loma Linda University, Loma Linda, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Range of Motion (as assessed by physician)

    Time frame: Up to 10 years

    Flexion, Extension, Ulnar, Radial

Secondary outcomes

  1. PROMIS Upper Extremity Physical Function 7a

    Time frame: 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.

  2. PROMIS Pain Interference 8a

    Time frame: 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

  3. PROMIS Global 10

    Time frame: 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

  4. Patient-Rated Wrist Evaluation Score (PRWE)

    Time frame: 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

  5. Hospital for Special Surgery Wrist Surgery Expectations Survey

    Time frame: 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

  6. Percentage of patients experiencing post-operative complications

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

  7. 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

  8. Grip and pinch strength (as assessed by physician)

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

    Grip and pinch strength

Study contacts

Contact information is provided by the study sponsor or research team.

Brian Smekal

CONTACT

[email protected]

+1 952-836-5698

Sponsors and collaborators

Lead sponsor

Extremity Medical

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2035
Study completion
2035
First posted
Feb 9, 2023
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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