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Clinical Trials/NCT06196528
NCT06196528UnknownNot Applicable

WristArt Total Wrist Arthroplasty Implant First In Human Study

Fibioseq Medical2 sites in 1 country5 target enrollmentStarted: January 2, 2024Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
5
Locations
2
Primary Endpoint
Number of Device Related Serious Adverse events at 6 months post operation
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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.)

Arms & Interventions

WristArt implantation

Experimental

Intervention: WristArt implant (Device)

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • Number of Device Related Serious Adverse events at 24 months post operation(24 months following implantation)
  • 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 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 Range of motion as measured by a goniometer(1 month, 3 months, 6 months, 1 year, 2 years)
  • Average Surgical Satisfaction Questionnaire (SSQ-8)(1 year)
  • 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(1 year)
  • 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)

Investigators

Sponsor
Fibioseq Medical
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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