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Safety, Tolerability and Efficacy of HAVAI, for Correction of Inter-metatarsal Angle

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02831868
Recruitment Status : Unknown
Verified March 2018 by Rabin Medical Center.
Recruitment status was:  Recruiting
First Posted : July 13, 2016
Last Update Posted : September 4, 2018
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

Brief Summary:
A non-inferiority study to demonstrate efficacy of the HAVAI minimally invasive device compared to standard of surgical care 1st metatarsal osteotomy (SSOC)

Condition or disease Intervention/treatment Phase
Hallux Valgus Device: HAVAI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EXP
Implantation of a HAVAI device to correct HVA without osteotomy
Device: HAVAI
implantation of the HAVAI device to correct the IMA angle




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult males and female subjects, aged 20 to 75 years old, inclusive, at screening visit.
  2. Subject weighing <100 kg and body mass index (BMI) <32 kg/m2.
  3. Subjects with confirmed diagnosis of HV deformity based on radiography assessment of IMA 12°-15°.
  4. Able and willing to comply with the requirements of the protocol.
  5. Able to understand and sign written informed consent to participate in the study.

Exclusion Criteria:

  1. 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)
  2. History of:

    a. 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).

    c. 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.

  3. Aseptic necrosis or any deformity of MT2 head.
  4. Aseptic necrosis of the MT1 head
  5. Pregnant women or women with childbearing potential who are not obliged to take any contraception measures
  6. 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)
  7. ASA grade above 2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831868


Contacts
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Contact: Daniel Billig, MBA 02-6553333 dbillig@bonfixmedical.com
Contact: Ayelet Goldwasser, CTA 052-5771144 ayelet@duet-medical.com

Locations
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Israel
Rambam Hospital Not yet recruiting
Haifa, Israel
Contact: Eyal Melamed, MD    0502062277    eyalfoot@gmail.com   
Contact: Eyal Melamed, MD         
Bonfix Ltd Recruiting
Jerusalem, Israel, 91391
Contact: Daniel Billig, MBA    02-6553333    dbillig@bonfixmedical.com   
Sponsors and Collaborators
Rabin Medical Center
Investigators
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Principal Investigator: Eyal Heller, MD Rabin MC

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Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02831868    
Other Study ID Numbers: 415-16
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: September 4, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hallux Valgus
Foot Deformities
Musculoskeletal Diseases