Hallux ValgusNCT02831868
Safety, Tolerability and Efficacy of HAVAI, for Correction of Inter-metatarsal Angle
A study testing HAVAI in people with Hallux Valgus, run by Rabin Medical Center at 2 sites in Israel.
Trial summary
A non-inferiority study to demonstrate efficacy of the HAVAI minimally invasive device compared to standard of surgical care 1st metatarsal osteotomy (SSOC) Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- HAVAI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesIsrael
- Study dates
- 1 Mar 2018to Dec 2019
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males and female subjects, aged 20 to 75 years old, inclusive, at screening visit.
- Subject weighing <100 kg and body mass index (BMI) <32 kg/m2.
- Subjects with confirmed diagnosis of HV deformity based on radiography assessment of IMA 12°-15°.
- Able and willing to comply with the requirements of the protocol.
- Able to understand and sign written informed consent to participate in the study.
Who cannot join
- Patients who need or may need to have 2nd MT osteotomy as part of their index surgery (e.g. instability or subluxation of 2nd MTPJ)
- History of:
- Severe Diabetes mellitus (defined as existence of: i. More than 10 years duration ii. HbA1C 8.0 < iii. any known complications of diabetes (PVD, Nephropathy [CR>1.3], retinopathy, IHD)) b. Claudication, known peripheral vascular disease or no palpable pulses (DP or TP).
- Known rheumatoid or inflammatory disease. d. X-ray evidence of moderate osteoarthritis of MTPJ-1 or TMTJ-1. e. neurological conditions associated with spasticity or lower limb paralysis. f. Prior operation on MT1 or MT2. g. Fracture (past or present) of MT1 or MT2.
- Aseptic necrosis or any deformity of MT2 head.
- Aseptic necrosis of the MT1 head
Show all 9Show fewer
- Pregnant women or women with childbearing potential who are not obliged to take any contraception measures
- Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
- ASA grade above 2
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Not yet recruiting
Rambam Hospital
Haifa
Eyal Melamed, MD, 0502062277, eyalfoot@gmail.com
Eyal Melamed, MD
- Recruiting
Bonfix Ltd
Jerusalem, 91391
Daniel Billig, MBA, 02-6553333, dbillig@bonfixmedical.com
About this study
Official title: Multi Center, Open-label, Single Arm, Study Designed to Evaluate Safety, Tolerability and Efficacy of HAVAI, a Minimally Invasive Implant Composed of Spring, Double Anchor and Suture, Versus Standard of Care 1st Metatarsal Osteotomy, for Correction of Inter-metatarsal Angle in Subjects Suffering From Hallux Valgus Deformity
A non-inferiority study to demonstrate efficacy of the HAVAI minimally invasive device compared to standard of surgical care 1st metatarsal osteotomy (SSOC)
- Conditions
- Hallux Valgus
- Being tested
- HAVAI
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAVAIDevice
implantation of the HAVAI device to correct the IMA angle
| Study group | Role | What they receive |
|---|---|---|
| EXP | Experimental | Implantation of a HAVAI device to correct HVA without osteotomy Receives: Device: HAVAI |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change in IMA angle
A change in IMA angle - compared to baseline using t test for repeated measures with 0.05 significance level.
Measured: 50 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study start1 Mar 2018
- Primary completionMay 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies 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
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eyal Heller, MD, Principal investigator, Rabin MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831868
- Sponsor's protocol ID
- 415-16
- Status last verified
- Mar 2018
- First submitted
- 11 Jul 2016
- Last updated
- 4 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Center, Open-label, Single Arm, Study Designed to Evaluate Safety, Tolerability and Efficacy of HAVAI, a Minimally Invasive Implant Composed of Spring, Double Anchor and Suture, Versus Standard of Care 1st Metatarsal Osteotomy, for Correction of Inter-metatarsal Angle in Subjects Suffering From Hallux Valgus Deformity
- ClinicalTrials.gov ID
- NCT02831868
- Acronym / sponsor ID
- 415-16
- Conditions
- Hallux Valgus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 13 Jul 2016 (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.
A non-inferiority study to demonstrate efficacy of the HAVAI minimally invasive device compared to standard of surgical care 1st metatarsal osteotomy (SSOC)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EXP | Experimental | Device: HAVAIImplantation of a HAVAI device to correct HVA without osteotomy |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult males and female subjects, aged 20 to 75 years old, inclusive, at screening visit.
- Subject weighing <100 kg and body mass index (BMI) <32 kg/m2.
- Subjects with confirmed diagnosis of HV deformity based on radiography assessment of IMA 12°-15°.
- Able and willing to comply with the requirements of the protocol.
- Able to understand and sign written informed consent to participate in the study.
Key exclusion criteria (9 listed)
- Patients who need or may need to have 2nd MT osteotomy as part of their index surgery (e.g. instability or subluxation of 2nd MTPJ)
- History of:
- Aseptic necrosis or any deformity of MT2 head.
- Aseptic necrosis of the MT1 head
- Pregnant women or women with childbearing potential who are not obliged to take any contraception measures
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 |
|---|---|---|
| HAVAIimplantation of the HAVAI device to correct the IMA angle | Device | EXP |
Primary outcome
A change in IMA angle
Time frame: 50 weeks
A change in IMA angle - compared to baseline using t test for repeated measures with 0.05 significance level.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Eyal Heller, MD principal investigator
Rabin MC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HAVAI in people with Hallux Valgus, run by Rabin Medical Center at 2 sites 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 5 inclusion and 9 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 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Daniel Billig, MBA (02-6553333, dbillig@bonfixmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A change in IMA angle (time frame: 50 weeks). 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 4 Sep 2018.