Evaluate Initial Safety of the HemiBridge™ System in Guided Spinal Growth Treatment of Progressive Idiopathic Scoliosis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Children's Hospital Medical Center, Cincinnati
University Hospital Case Medical Center
Information provided by (Responsible Party):
SpineForm LLC
ClinicalTrials.gov Identifier:
NCT01465295
First received: October 28, 2011
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

The purpose of this clinical trial is to study a new method of treatment for patients who are diagnosed with idiopathic scoliosis and have abnormal and increasing curvature of the spine. The treatment consists of the surgical implantation of a new medical device called the "HemiBridge™ Clip". This medical implant device has never been used in humans. SpineForm, LLC, the developer of the HemiBridgeTM System has designed this scientific clinical trial, to evaluate the safety of the use of this device in humans. Information collected from patients treated with this new device shall be used to determine the initial safety of the new device.

The FDA has approved the use of the HemibridgeTM System for this research study in 6 (six) pediatric patients who have idiopathic scoliosis.

This procedure is intended to stop additional curvature of the spine by redirecting growth of the bones of the spine (vertebrae). To accomplish this, the patient undergoes a surgical procedure to securely attach small metal clips (HemiBridge™ Clips) to the outer side of each vertebra involved in the curvature. The HemiBridge™ Clip forms a "bridge" between each vertebra and is intended to hold the vertebrae in place to prevent the spine from curving any further.


Condition Intervention
Scoliosis
Device: Mechanical hemiepiphysiodesis using the HemiBridge System

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Trial to Evaluate Initial Safety of the HemiBridge™ System in Guided Spinal Growth Treatment of Progressive Idiopathic Scoliosis

Resource links provided by NLM:


Further study details as provided by SpineForm LLC:

Primary Outcome Measures:
  • Acute Safety: Incidence, relatedness (relationship to procedure and device), seriousness and severity of Adverse Events By Participant [ Time Frame: 1 month post-operative ] [ Designated as safety issue: No ]
    Incidence, relatedness (relationship to procedure and device), seriousness and severity of Adverse Events By Participant


Enrollment: 6
Study Start Date: August 2011
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HemiBridge
Patients meeting eligibility criteria will be treated with the HemiBridge System.
Device: Mechanical hemiepiphysiodesis using the HemiBridge System
Surgical application of mechanical hemiepiphysiodesis using the HemiBridge device.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Patients must meet all the criteria to be enrolled in this study:

  • Trial subject population will involve patients who are skeletally immature, who have a diagnosis of idiopathic scoliosis with a single main thoracic curve Cobb angle 25° to 40° and Lenke Type 1A or 1B.

    1. Chronologic age:

      • Males ≥ 10 years
      • Females ≥ 10 years
    2. Females pre-menarchal at screening examination
    3. Bone age as confirmed by radiographs of left hand and wrist according to the "Atlas Matching" method of Greulich and Pyle:

      • Females: ≥ 8 years and 10 months not to exceed 13 years
      • Males: ≥ 10 years not to exceed 15 years
    4. Skeletal immaturity (Risser grade 0 and the triradiate cartilage is open) as determined by standing, upright PA radiograph. If radiographic Risser grade results are indeterminate, the bone age from the Atlas Matching will prevail.
    5. Main thoracic Cobb angle of 25° to 40° as determined from standing, upright PA radiographs where the end vertebra are between or including T3 and L1 without wearing a brace
    6. Clinical diagnosis of idiopathic scoliosis with a single main thoracic curve as determined with measurement on standing posterior- anterior PA radiographs.

      • Defined as a single thoracic curve where either: central sacral vertical line (CSVL) passes between the pedicles of the apical lumbar vertebra; or the CSVL touches the lumbar apical body(ies) (Lenke Type 1A or 1B, respectively)
    7. Achievable anatomical fit as determined by calibrated standing PA film:

      • Disc height not exceeding 10 mm at each spinal level to be instrumented relative to location of the probable implant and
      • Minimum central vertebral height that will accept the selected HemiBridge™ Clip size at all levels planned for implants
    8. BMI < 30
    9. Physical and mental ability to undergo surgery with single lung ventilation
    10. Written informed assent from the patient
    11. Written informed consent from parent and/or legal guardian and authorization to use protected health information (by Sponsor, third party core lab and/or clinical evaluation committee)

Exclusion Criteria:

  • Patients who meet any of the exclusion criteria will not be enrolled.

    1. Non-idiopathic scoliosis
    2. Males and females chronological age < 10 years
    3. Triradiate cartilage is closed as determined on the standing PA radiograph at baseline screening
    4. Any curve type that does not meet definition of Lenke 1A or 1B
    5. Any main thoracic deformity that measures < 25° or > 40° Cobb angle
    6. Any main thoracic deformity that includes vertebral levels including and cranial to T2
    7. Any main thoracic deformity that includes vertebral levels including and caudal to L2
    8. Prior thoracotomy, thoracostomy or any spine surgery
    9. T3-T12 kyphosis > 40° (T4 or T5-T12 if visualization impaired at T3)
    10. Known history or existing malignancy, or any systemic or local infection
    11. Spinal cord abnormalities that require treatment
    12. Presence of neurological deficit (motor grades 0-4, sensory grades 0-1, reflexes grade 0 or 5 or asymmetry of deep tendon reflexes > 2 from right to left)
    13. Insulin-dependent diabetes
    14. Severe asthma
    15. Reduced pulmonary function, defined as < 60% of predicted value (Forced expiratory volume in one second [FEV1] divided by forced vital capacity [FVC]) or Subject has moderately severe or worse ventilatory limitation defined as < 60% of predicted value of the forced vital capacity [FVC] for age, race, sex and height (with height determined by arm span in patients with scoliosis and reference equations derived from the data of Wang et al 199329.)
    16. Cardiopulmonary or other systemic disease
    17. Bleeding disorder(s)
    18. Ataxia
    19. Documented HIV or hepatitis infection
    20. Family history of neurofibromatosis or Marfan's syndrome
    21. Medical contraindication to anesthesia
    22. Suspected or known allergy to titanium
    23. Not available for interval visits and long term follow-up exams
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465295

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
University Hospitals Case Medical Center - Rainbow Babies & Children's Hospital
Cleveland, Ohio, United States, 44115
Sponsors and Collaborators
SpineForm LLC
Children's Hospital Medical Center, Cincinnati
University Hospital Case Medical Center
Investigators
Study Director: Joseph E Reynolds, MBA SpineForm LLC
Principal Investigator: Eric J Wall, MD Children's Hospital Medical Center, Cincinnati
  More Information

Additional Information:
Publications:

Responsible Party: SpineForm LLC
ClinicalTrials.gov Identifier: NCT01465295     History of Changes
Other Study ID Numbers: SF001, 11-042, R01FD004144-01
Study First Received: October 28, 2011
Last Updated: August 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by SpineForm LLC:
Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Scoliosis treatment
Fusionless spinal surgery
Vertebral stapling
Spinal stapling
Non-fusion
Spinal curvature
Curvature of the spine
Spinal bracing alternative
HemiBridge
SpineForm
Dr. Eric Wall
Dr. George Thompson
Spinal clip
Cincinnati Children's Hospital Medical Center
University Hospitals Case Medical Center, Rainbow Babies

Additional relevant MeSH terms:
Scoliosis
Bone Diseases
Musculoskeletal Diseases
Spinal Curvatures
Spinal Diseases

ClinicalTrials.gov processed this record on October 29, 2014