The KinematX Midcarpal Total Wrist Arthroplasty Registry

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05719935
• Other study ID #: 112020-1
• Status: Recruiting
• Start date: April 26, 2021
• Est. completion date: December 2035

Study information

• Verified date: November 2023
• Source: Extremity Medical
• Contact: Brian Smekal
• Phone: +1 952-836-5698
• Email: bsmekal[@]extremitymedical.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2035
• Est. primary completion date: December 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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,

• Kienb?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

Related Conditions & MeSH terms

• Arthritis
• Carpal Tunnel Syndrome
• Carpal Tunnel Syndrome (CTS)
• Inflammatory Arthritis
• Osteoarthritis
• Osteonecrosis
• Post Traumatic Arthritis
• Shock

Intervention

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.

Locations

Country	Name	City	State
United States	Franciscan Health	Indianapolis	Indiana
United States	Loma Linda University	Loma Linda	California
United States	Hospital for Special Surgery	New York	New York
United States	Florida Orthopaedic Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Extremity Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of Motion (as assessed by physician)	Flexion, Extension, Ulnar, Radial	Up to 10 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of patients experiencing post-operative complications		3 months, 6 months, yearly up to 10 years post-surgery
Secondary	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
Secondary	Grip and pinch strength (as assessed by physician)	Grip and pinch strength	3months, 6 months, yearly up to 10 years post-surgery