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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

Tracking Information
First Submitted Date  ICMJE July 11, 2016
First Posted Date  ICMJE July 13, 2016
Last Update Posted Date September 4, 2018
Actual Study Start Date  ICMJE March 1, 2018
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 12, 2016)
An improvment in IMA angel [ Time Frame: 50 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and Efficacy of HAVAI, for Correction of Inter-metatarsal Angle
Official Title  ICMJE 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
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hallux Valgus
Intervention  ICMJE Device: HAVAI
implantation of the HAVAI device to correct the IMA angle
Study Arms  ICMJE Experimental: EXP
Implantation of a HAVAI device to correct HVA without osteotomy
Intervention: Device: HAVAI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 12, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02831868
Other Study ID Numbers  ICMJE 415-16
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rabin Medical Center
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eyal Heller, MD Rabin MC
PRS Account Rabin Medical Center
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP