WristArt Total Wrist Arthroplasty Implant First In Human Study

Wrist Osteoarthritis Clinical Trial

Official title:

WristArt Total Wrist Arthroplasty Implant First In Human Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06196528
• Other study ID #: CLN-0001
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: February 28, 2026

Study information

• Verified date: December 2023
• Source: Fibioseq Medical
• Contact: Amir Oron, MD
• Phone: 972-8-9441340
• Email: amiroronmd[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: February 28, 2026
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Osteoarthritis
• Wrist Osteoarthritis

Intervention

Device:
• WristArt implant
implantation of the WristArt implant

Locations

Country	Name	City	State
Israel	Kaplan Medical Center	Re?ovot

Sponsors (1)

Lead Sponsor	Collaborator
Fibioseq Medical

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Device Related Serious Adverse events at 6 months post operation	Implantation Safety profile at 6 months post operation	6 months post operation
Primary	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	Number of Device Related Serious Adverse events at 24 months post operation	Implantation Safety profile at 24 months post operation	24 months following implantation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Implant loosening rate per radiological measurements	Implant loosening rate per radiological measurements	1 month, 3 months, 6 months, 1 year, 2 years
Secondary	Metal Ion Levels in blood at 1 year following surgery	Metal Ion Levels in blood at 1 year following surgery	1 year
Secondary	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
Secondary	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