The KinematX Midcarpal Total Wrist Arthroplasty Registry | NCT05719935

Studies
The KinematX Midcarpal Total Wrist Arthroplasty Registry

NCT05719935

Sponsor

Extremity Medical

Status

Recruiting

Last Update Posted

Nov 15, 2023Actual

Enrollment

50Estimated

Phase

Not provided

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)

Interventions

KinematX total wrist arthroplasty system

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 26, 2021Actual

Primary Completion Date

Dec 2035Estimated

Completion Date

Dec 2035Estimated

First Submitted Date

Dec 19, 2022

First Submission Date that Met QC Criteria

Jan 30, 2023

First Posted Date

Feb 9, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2023

Last Update Posted Date

Nov 15, 2023Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
KinematX patients		Patients undergoing total wrist replacement with the KinematX implant.	Device: KinematX total wrist arthroplasty system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Range of Motion (as assessed by physician)	Flexion, Extension, Ulnar, Radial	Up to 10 years

Secondary Outcomes

Measure	Description	Time Frame
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
PROMIS Pain Interference 8a

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

ID	Term
D020423	Median Neuropathy
D020422	Mononeuropathies
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D009408	Nerve Compression Syndromes
D012090	Cumulative Trauma Disorders
D013180	Sprains and Strains
D014947	Wounds and Injuries
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

ID	Term
D002349	Carpal Tunnel Syndrome
D001168	Arthritis
D010003	Osteoarthritis