Lesion of Ligament of Wrist and/or HandNCT02042846
Clinical Evaluation of the SportWelding FijiAnchor® in Hand and Hand Wrist Surgery
A study testing SportWelding Fiji Anchor in people with Lesion of Ligament of Wrist and/or Hand, run by SportWelding GmbH at 1 site in Austria.
Trial summary
The SportWelding FijiAnchor is an absorbable suture anchor which is inserted by applying ultrasonic energy. This provides an intimate bond between implant and bone delivering immediate stability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lesion of Ligament of Wrist and/or Hand
- What is being tested?
- SportWelding Fiji Anchor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2014to Jun 2016
- 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
- Having a condition requiring (re)fixation or (re)construction of ligaments in the hand or hand wrist
- Being able to comprehend, sign, and date the written informed consent form (ICF)); and
- Being able to visit the hospital to be examined the repaired region after the procedure.
Who cannot join
- Having serious concomitant disease
- Being pregnant
- Having the control hand not suitable to serve as comparator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Clinical Evaluation of the Bioabsorbable SportWelding FijiAnchor® for Ligament Repair of the Hand and Hand Wrist
The SportWelding FijiAnchor is an absorbable suture anchor which is inserted by applying ultrasonic energy. This provides an intimate bond between implant and bone delivering immediate stability.
The purpose of this study is to evaluate the surgical and clinical outcome of the SportWelding Fiji Anchor in ligament repair of the hand and hand wrist.
- Conditions
- Lesion of Ligament of Wrist and/or Hand
- Being tested
- SportWelding Fiji Anchor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SportWelding Fiji AnchorDevice
| Study group | Role | What they receive |
|---|---|---|
| SportWelding Fiji Anchor | Experimental | Not described Receives: Device: SportWelding Fiji Anchor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation success
Technical success confirmed at the end of surgery by mean of an assessment form (e.g anchor insertion without breaking and suture without pulling off from the tissue during surgery).
Measured: Day 1
Procedure success
No dislodged/broken anchor nor ruptured sutures observed at 2, 6 and 12 weeks post operative evaluation
Measured: 12 weeks
Secondary outcomes (2)
Clinical function
Dash (Disabilities of the Arm, Shoulder and Hand) Score, PRWE (Patient-Related-Wrist-Evaluation) Score and strength of the operated and the non-operated control hand will be recorded after 6 and 12 months.
Measured: 3 and 6 months
Adverse events
All adverse events will be recorded
Measured: From Day 1 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lesion of Ligament of Wrist and/or HandStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SportWelding GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rohit Arora, MD, Principal investigator, Univ.-Klinik für Unfallchirurgie Innsbruck, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042846
- Sponsor's protocol ID
- Spo-01
- Status last verified
- Nov 2015
- First submitted
- 9 Jan 2014
- Last updated
- 18 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Evaluation of the Bioabsorbable SportWelding FijiAnchor® for Ligament Repair of the Hand and Hand Wrist
- ClinicalTrials.gov ID
- NCT02042846
- Acronym / sponsor ID
- Spo-01
- Conditions
- Lesion of Ligament of Wrist and/or Hand
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- SportWelding GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 23 Jan 2014 (estimated)
- 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 SportWelding FijiAnchor is an absorbable suture anchor which is inserted by applying ultrasonic energy. This provides an intimate bond between implant and bone delivering immediate stability.
The purpose of this study is to evaluate the surgical and clinical outcome of the SportWelding Fiji Anchor in ligament repair of the hand and hand wrist.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SportWelding Fiji Anchor | Experimental | Device: SportWelding Fiji Anchor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having a condition requiring (re)fixation or (re)construction of ligaments in the hand or hand wrist
- Being able to comprehend, sign, and date the written informed consent form (ICF)); and
- Being able to visit the hospital to be examined the repaired region after the procedure.
Key exclusion criteria (3 listed)
- Having serious concomitant disease
- Being pregnant
- Having the control hand not suitable to serve as comparator
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 |
|---|---|---|
| SportWelding Fiji Anchor | Device | SportWelding Fiji Anchor |
Primary outcome
Operation success
Time frame: Day 1
Technical success confirmed at the end of surgery by mean of an assessment form (e.g anchor insertion without breaking and suture without pulling off from the tissue during surgery).
Procedure success
Time frame: 12 weeks
No dislodged/broken anchor nor ruptured sutures observed at 2, 6 and 12 weeks post operative evaluation
2 secondary outcomes
Clinical function
Time frame: 3 and 6 months
Adverse events
Time frame: From Day 1 to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
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.
Rohit Arora, MD principal investigator
Univ.-Klinik für Unfallchirurgie Innsbruck, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SportWelding Fiji Anchor in people with Lesion of Ligament of Wrist and/or Hand, run by SportWelding GmbH at 1 site in Austria.
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 3 inclusion and 3 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 18 Nov 2015. 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 Austria. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operation success (time frame: Day 1). 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 18 Nov 2015.