WristArt Total Wrist Arthroplasty Implant First In Human Study

February 21, 2024 updated by: Fibioseq Medical
The WristArt implant will be implanted for the first time in humans' wrists

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects suffering from one the following conditions:

    1. Osteoarthritis (OA) of the wrist joint due to various causes (age, trauma, Avascular Necrosis)
    2. Rheumatoid arthritis of the wrist joint or other rheumatological diseases which destroy the wrist joint
    3. Unrepairable previous intraarticular fractures of the distal radius, scaphoid or lunate bones of the wrist joint (i.e., historical fractures that were failed to fuse surgically)
    4. Symptomatic congenital abnormalities around wrist joint such as carpal bones coalition, mild forms of Madelung's deformities etc.
    5. Patients who underwent failed proximal row carpectomy, or failed partial carpal bones fusion
  2. Patients who's their wrist x-ray shows no damage to the carpal bones that are not fused as part of the surgery
  3. Patient Rated Wrist Evaluation Score (PRWE) at baseline is above 70 points out of 100
  4. Visual Analog Pain Score (VAS) at baseline is above 70 points out of 100

Exclusion Criteria:

  1. Patients younger than 18 years old
  2. Patients for whom bone growth did not complete yet
  3. Paralytic hand patients
  4. Patients with sensitivity to Titanium (ADD/CHANGE MATERIALS AS NEEDED)
  5. Cerebral palsy patients with wrist joint contracture and loss of sensation in the hand
  6. Low quality of capitate bone and/or excessively short capitate bone (≥50% destruction) due to various causes (AVN, comminuted fracture, lytic lesions, congenital etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: WristArt implantation
Device: WristArt implant
implantation of the WristArt implant

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Device Related Serious Adverse events at 6 months post operation
Time Frame: 6 months post operation
Implantation Safety profile at 6 months post operation
6 months post operation
Number of cases with Fully and successfully implanted device at the end of surgery per surgeon's reporting and radiological imaging
Time Frame: 48 hours post-surgery
Implantation Success profile at the end of surgery
48 hours post-surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Device Related Serious Adverse events at 24 months post operation
Time Frame: 24 months following implantation
Implantation Safety profile at 24 months post operation
24 months following implantation
Average Pain Reduction levels according to Visual Analog Pain Score (VAS)
Time Frame: 1 month, 3 months, 6 months, 1 year, 2 years
Pain is calculated using a visual analog scale ranges from 1-10 (taken from the pain subscale of the Patient Reported Wrist Evaluation PRWE scale)
1 month, 3 months, 6 months, 1 year, 2 years
Average levels of change in functionality according to Patient Reported Wrist Evaluation (PRWE)
Time Frame: 1 month, 3 months, 6 months, 1 year, 2 years
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. scores range from 0 (no disability) to 100 (worse functional score)
1 month, 3 months, 6 months, 1 year, 2 years
Average levels of change in Grip Strength as measured by dynamometer
Time Frame: 1 month, 3 months, 6 months, 1 year, 2 years
levels of change in Grip Strength as measured by a dynamometer
1 month, 3 months, 6 months, 1 year, 2 years
Average levels of change in Range of motion as measured by a goniometer
Time Frame: 1 month, 3 months, 6 months, 1 year, 2 years
levels of change in Range of motion
1 month, 3 months, 6 months, 1 year, 2 years
Implant loosening rate per radiological measurements
Time Frame: 1 month, 3 months, 6 months, 1 year, 2 years
Implant loosening rate per radiological measurements
1 month, 3 months, 6 months, 1 year, 2 years
Metal Ion Levels in blood at 1 year following surgery
Time Frame: 1 year
Metal Ion Levels in blood at 1 year following surgery
1 year
Average Surgical Satisfaction Questionnaire (SSQ-8)
Time Frame: 1 year
SSQ8 is a 8-items instrument, with responses recorded on a 5-point Likert-type scale from 0 (worst) to 4 (best) and an overall score ranging from 0 (very unsatisfied) to 32 (very satisfied)
1 year
Levels of change in functionality according to quick DASH scores (0 - full function ; 100 - impaired functionality)
Time Frame: 1 month, 3 months, 6 months, 1 year, 2 years
Levels of change in functionality according to quick DASH scores
1 month, 3 months, 6 months, 1 year, 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fibioseq Medical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amir Oron, Kaplan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLN-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings