Clinical trial NCT06196528: WristArt Total Wrist Arthroplasty Implant First In Human Study
Official title: WristArt Total Wrist Arthroplasty Implant First In Human Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wrist Osteoarthritis
Lead sponsor: Fibioseq Medical
Sponsor class: INDUSTRY
First posted: 2024-01-09
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.)

Primary outcomes:
measure: Number of Device Related Serious Adverse events at 6 months post operation
timeFrame: 6 months post operation
measure: Number of cases with Fully and successfully implanted device at the end of surgery per surgeon's reporting and radiological imaging
timeFrame: 48 hours post-surgery
Secondary outcomes:
measure: Number of Device Related Serious Adverse events at 24 months post operation
timeFrame: 24 months following implantation
measure: Average Pain Reduction levels according to Visual Analog Pain Score (VAS)
timeFrame: 1 month, 3 months, 6 months, 1 year, 2 years
measure: Average levels of change in functionality according to Patient Reported Wrist Evaluation (PRWE)
timeFrame: 1 month, 3 months, 6 months, 1 year, 2 years
measure: Average levels of change in Grip Strength as measured by dynamometer
timeFrame: 1 month, 3 months, 6 months, 1 year, 2 years
measure: Average levels of change in Range of motion as measured by a goniometer
timeFrame: 1 month, 3 months, 6 months, 1 year, 2 years
measure: Implant loosening rate per radiological measurements
timeFrame: 1 month, 3 months, 6 months, 1 year, 2 years
measure: Metal Ion Levels in blood at 1 year following surgery
timeFrame: 1 year
measure: Average Surgical Satisfaction Questionnaire (SSQ-8)
timeFrame: 1 year
measure: Levels of change in functionality according to quick DASH scores (0 - full function ; 100 - impaired functionality)
timeFrame: 1 month, 3 months, 6 months, 1 year, 2 years
Other outcomes:
Locations:
city: Reẖovot
country: Israel
facility: Kaplan Medical Center
Study officials:
affiliation: Kaplan Medical Center
name: Amir Oron
role: PRINCIPAL_INVESTIGATOR
References: