WristArt Total Wrist Arthroplasty Implant First In Human Study

NCT06196528 | Recruiting

• 1 other identifier: CLN-0001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Wrist Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Number of Device Related Serious Adverse events at 24 months post operation

  24 months following implantation

• Average Pain Reduction levels according to Visual Analog Pain Score (VAS)

  1 month, 3 months, 6 months, 1 year, 2 years

• Average levels of change in functionality according to Patient Reported Wrist Evaluation (PRWE)

  1 month, 3 months, 6 months, 1 year, 2 years

• Average levels of change in Grip Strength as measured by dynamometer

  1 month, 3 months, 6 months, 1 year, 2 years

• Average levels of change in Range of motion as measured by a goniometer

  1 month, 3 months, 6 months, 1 year, 2 years

Study Arms (1)

WristArt implantation

EXPERIMENTAL

Device: WristArt implant

Interventions

WristArt implant DEVICE

implantation of the WristArt implant

WristArt implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects suffering from one the following conditions:
• Osteoarthritis (OA) of the wrist joint due to various causes (age, trauma, Avascular Necrosis)
• Rheumatoid arthritis of the wrist joint or other rheumatological diseases which destroy the wrist joint
• 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)
• Symptomatic congenital abnormalities around wrist joint such as carpal bones coalition, mild forms of Madelung's deformities etc.
• Patients who underwent failed proximal row carpectomy, or failed partial carpal bones fusion
• Patients who's their wrist x-ray shows no damage to the carpal bones that are not fused as part of the surgery
• Patient Rated Wrist Evaluation Score (PRWE) at baseline is above 70 points out of 100
• Visual Analog Pain Score (VAS) at baseline is above 70 points out of 100

You may not qualify if:

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

Sponsors & Collaborators

• Fibioseq Medical: lead

Study Sites (1)

Kaplan Medical Center

Rehovot, Israel

RECRUITING

Study Officials

• Amir Oron

  Kaplan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amir Oron, MD

CONTACT

972-8-9441340; amiroronmd@gmail.com

Shiran Rogof

CONTACT

+97289441340; shiranro1@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2023
• First Posted: January 9, 2024
• Study Start: January 2, 2024
• Primary Completion: August 30, 2024
• Study Completion: February 28, 2026
• Last Updated: February 22, 2024

Record last verified: 2023-12

Locations

IL (1)