Wrist OsteoarthritisNCT06196528
WristArt Total Wrist Arthroplasty Implant First In Human Study
A study testing WristArt implant in people with Wrist Osteoarthritis, run by Fibioseq Medical at 1 site in Israel.
Trial summary
The WristArt implant will be implanted for the first time in humans' wrists Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wrist Osteoarthritis
- What is being tested?
- WristArt implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIsrael
- Study dates
- 2 Jan 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Kaplan Medical Center
Rehovot
Amir Oron, MD, 972-8-9441340, amiroronmd@gmail.com
Shiran Rogof, 972-8-9441340, shiranro1@clalit.org.il
About this study
The WristArt implant will be implanted for the first time in humans' wrists
- Conditions
- Wrist Osteoarthritis
- Being tested
- WristArt implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WristArt implantDevice
implantation of the WristArt implant
| Study group | Role | What they receive |
|---|---|---|
| WristArt implantation | Experimental | Not described Receives: Device: WristArt implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Device Related Serious Adverse events at 6 months post operation
Implantation Safety profile at 6 months post operation
Measured: 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
Measured: 48 hours post-surgery
Secondary outcomes (9)
Number of Device Related Serious Adverse events at 24 months post operation
Implantation Safety profile at 24 months post operation
Measured: 24 months following implantation
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)
Measured: 1 month, 3 months, 6 months, 1 year, 2 years
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)
Measured: 1 month, 3 months, 6 months, 1 year, 2 years
Average levels of change in Grip Strength as measured by dynamometer
levels of change in Grip Strength as measured by a dynamometer
Measured: 1 month, 3 months, 6 months, 1 year, 2 years
Average levels of change in Range of motion as measured by a goniometer
levels of change in Range of motion
Measured: 1 month, 3 months, 6 months, 1 year, 2 years
Implant loosening rate per radiological measurements
Implant loosening rate per radiological measurements
Measured: 1 month, 3 months, 6 months, 1 year, 2 years
Metal Ion Levels in blood at 1 year following surgery
Metal Ion Levels in blood at 1 year following surgery
Measured: 1 year
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)
Measured: 1 year
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
Measured: 1 month, 3 months, 6 months, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start2 Jan 2024
- Primary completion30 Aug 2024 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fibioseq Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amir Oron, Principal investigator, Kaplan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196528
- Sponsor's protocol ID
- CLN-0001
- Status last verified
- Dec 2023
- First submitted
- 26 Nov 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WristArt Total Wrist Arthroplasty Implant First In Human Study
- ClinicalTrials.gov ID
- NCT06196528
- Acronym / sponsor ID
- CLN-0001
- Conditions
- Wrist Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Fibioseq MedicalIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The WristArt implant will be implanted for the first time in humans' wrists
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WristArt implantation | Experimental | Device: WristArt implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects suffering from one the following conditions:
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WristArt implantimplantation of the WristArt implant | Device | WristArt implantation |
Primary outcome
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
9 secondary outcomes
Number of Device Related Serious Adverse events at 24 months post operation
Time frame: 24 months following implantation
Average Pain Reduction levels according to Visual Analog Pain Score (VAS)
Time frame: 1 month, 3 months, 6 months, 1 year, 2 years
Average levels of change in functionality according to Patient Reported Wrist Evaluation (PRWE)
Time frame: 1 month, 3 months, 6 months, 1 year, 2 years
Average levels of change in Grip Strength as measured by dynamometer
Time frame: 1 month, 3 months, 6 months, 1 year, 2 years
Average levels of change in Range of motion as measured by a goniometer
Time frame: 1 month, 3 months, 6 months, 1 year, 2 years
Implant loosening rate per radiological measurements
Time frame: 1 month, 3 months, 6 months, 1 year, 2 years
Metal Ion Levels in blood at 1 year following surgery
Time frame: 1 year
Average Surgical Satisfaction Questionnaire (SSQ-8)
Time frame: 1 year
Levels of change in functionality according to quick DASH scores (0 - full function ; 100 - impaired functionality)
Time frame: 1 month, 3 months, 6 months, 1 year, 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Oron principal investigator
Kaplan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WristArt implant in people with Wrist Osteoarthritis, run by Fibioseq Medical at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amir Oron, MD (972-8-9441340, amiroronmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Device Related Serious Adverse events at 6 months post operation (time frame: 6 months post operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.