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

Completed · Not applicable

Conditions studied: Scoliosis

In brief

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.

Key facts

Study ID

NCT01465295

Run by

SpineForm LLC

People needed

6

Starts

2011-08-01

Expected to finish

2017-12-29

Last updated by the study team

2018-02-05

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Chronologic age:
• Males ≥ 10 years
• Females ≥ 10 years
• Females pre-menarchal at screening examination
• 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
• 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.
• 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
• 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)
• 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
• BMI < 30
• Physical and mental ability to undergo surgery with single lung ventilation
• Written informed assent from the patient
• 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)

You may not qualify if…

• Patients who meet any of the exclusion criteria will not be enrolled.
• Non-idiopathic scoliosis
• Males and females chronological age < 10 years
• Triradiate cartilage is closed as determined on the standing PA radiograph at baseline screening
• Any curve type that does not meet definition of Lenke 1A or 1B
• Any main thoracic deformity that measures < 25° or > 40° Cobb angle
• Any main thoracic deformity that includes vertebral levels including and cranial to T2
• Any main thoracic deformity that includes vertebral levels including and caudal to L2
• Prior thoracotomy, thoracostomy or any spine surgery
• T3-T12 kyphosis > 40° (T4 or T5-T12 if visualization impaired at T3)
• Known history or existing malignancy, or any systemic or local infection
• Spinal cord abnormalities that require treatment
• 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)
• Insulin-dependent diabetes
• Severe asthma
• 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.)
• Cardiopulmonary or other systemic disease
• Bleeding disorder(s)
• Ataxia
• Documented HIV or hepatitis infection
• Family history of neurofibromatosis or Marfan's syndrome
• Medical contraindication to anesthesia
• Suspected or known allergy to titanium
• Not available for interval visits and long term follow-up exams

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• University Hospitals Case Medical Center - Rainbow Babies & Children's Hospital — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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