WristArt Total Wrist Arthroplasty Implant First In Human Study

Not Applicable

Recruiting

• Conditions: Wrist Osteoarthritis
• Interventions: Device: WristArt implant

• Registration Number: NCT06196528
• Lead Sponsor: Fibioseq Medical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-26
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-25
• Study Start: 2024-01-02
• Study First Posted: 2024-01-09
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-22
• Primary Completion: 2024-08-30
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
WristArt implantation	WristArt implant	-

Primary Outcome Measures

Name	Time	Method
Number of Device Related Serious Adverse events at 6 months post operation	6 months post operation	Implantation Safety profile at 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	48 hours post-surgery	Implantation Success profile at the end of surgery

Secondary Outcome Measures

Name	Time	Method
Number of Device Related Serious Adverse events at 24 months post operation	24 months following implantation	Implantation Safety profile at 24 months post operation
Average levels of change in functionality according to Patient Reported Wrist Evaluation (PRWE)	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)
Average levels of change in Grip Strength as measured by dynamometer	1 month, 3 months, 6 months, 1 year, 2 years	levels of change in Grip Strength as measured by a dynamometer
Average Pain Reduction levels according to Visual Analog Pain Score (VAS)	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)
Average levels of change in Range of motion as measured by a goniometer	1 month, 3 months, 6 months, 1 year, 2 years	levels of change in Range of motion
Average Surgical Satisfaction Questionnaire (SSQ-8)	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)
Implant loosening rate per radiological measurements	1 month, 3 months, 6 months, 1 year, 2 years	Implant loosening rate per radiological measurements
Metal Ion Levels in blood at 1 year following surgery	1 year	Metal Ion Levels in blood at 1 year following surgery
Levels of change in functionality according to quick DASH scores (0 - full function ; 100 - impaired functionality)	1 month, 3 months, 6 months, 1 year, 2 years	Levels of change in functionality according to quick DASH scores

Trial Locations

Locations (1)

Kaplan Medical Center; 🇮🇱 Reẖovot, Israel