WristArt Total Wrist Arthroplasty Implant First In Human Study

The WristArt implant will be implanted for the first time in humans' wrists

Study Overview

• Status: Recruiting
• Conditions: Wrist Osteoarthritis
• Intervention / Treatment: Device: WristArt implant

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amir Oron, MD; Phone Number: 972-8-9441340; Email: amiroronmd@gmail.com
• Study Contact Backup: Name: Shiran Rogof; Phone Number: +97289441340; Email: shiranro1@clalit.org.il

Study Locations

• Israel
  • Reẖovot, Israel
    • Recruiting
    • Kaplan Medical Center
    • Contact: Amir Oron, MD; Phone Number: 972-8-9441340; Email: amiroronmd@gmail.com
    • Contact: Shiran Rogof; Phone Number: 972-8-9441340; Email: shiranro1@clalit.org.il

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WristArt implantation	Device: WristArt implant; implantation of the WristArt implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Device Related Serious Adverse events at 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	Implantation Success profile at the end of surgery	48 hours post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Device Related Serious Adverse events at 24 months post operation	Implantation Safety profile at 24 months post operation	24 months following implantation
Average Pain Reduction levels according to Visual Analog Pain Score (VAS)	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)	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	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	levels of change in Range of motion	1 month, 3 months, 6 months, 1 year, 2 years
Implant loosening rate per radiological measurements	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	Metal Ion Levels in blood at 1 year following surgery	1 year
Average Surgical Satisfaction Questionnaire (SSQ-8)	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)	Levels of change in functionality according to quick DASH scores	1 month, 3 months, 6 months, 1 year, 2 years

Collaborators and Investigators

• Sponsor: Fibioseq Medical
• Investigators: Principal Investigator: Amir Oron, Kaplan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2024
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: November 26, 2023
• First Submitted That Met QC Criteria: December 25, 2023
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Actual): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID 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