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

NCT01465295 | Completed DMC

• 3 other identifiers: SF00111-042R01FD004144-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Scoliosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Acute Safety: Incidence, relatedness (relationship to procedure and device), seriousness and severity of Adverse Events By Participant

  Incidence, relatedness (relationship to procedure and device), seriousness and severity of Adverse Events By Participant

  1 month post-operative

Study Arms (1)

HemiBridge

EXPERIMENTAL

Patients meeting eligibility criteria will be treated with the HemiBridge System.

Device: Mechanical hemiepiphysiodesis using the HemiBridge System

Interventions

Mechanical hemiepiphysiodesis using the HemiBridge System DEVICE

Surgical application of mechanical hemiepiphysiodesis using the HemiBridge device.

HemiBridge

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• SpineForm LLC: lead
• Children's Hospital Medical Center, Cincinnati: collaborator
• University Hospitals Cleveland Medical Center: collaborator

Study Sites (2)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

University Hospitals Case Medical Center - Rainbow Babies & Children's Hospital

Cleveland, Ohio, 44115, United States

Location

Related Publications (12)

• Bunge EM, de Koning HJ; brace trial group. Bracing patients with idiopathic scoliosis: design of the Dutch randomized controlled treatment trial. BMC Musculoskelet Disord. 2008 Apr 22;9:57. doi: 10.1186/1471-2474-9-57.

  PMID: 18430217 BACKGROUND

• Guille JT, D'Andrea LP, Betz RR. Fusionless treatment of scoliosis. Orthop Clin North Am. 2007 Oct;38(4):541-5, vii. doi: 10.1016/j.ocl.2007.07.003.

  PMID: 17945133 BACKGROUND

• Wiggins GC, Shaffrey CI, Abel MF, Menezes AH. Pediatric spinal deformities. Neurosurg Focus. 2003 Jan 15;14(1):e3. doi: 10.3171/foc.2003.14.1.4.

  PMID: 15766220 BACKGROUND

• Lonner BS. Emerging minimally invasive technologies for the management of scoliosis. Orthop Clin North Am. 2007 Jul;38(3):431-40; abstract vii-viii. doi: 10.1016/j.ocl.2007.03.011.

  PMID: 17629990 BACKGROUND

• Arlet V. Anterior thoracoscopic spine release in deformity surgery: a meta-analysis and review. Eur Spine J. 2000 Feb;9 Suppl 1(Suppl 1):S17-23. doi: 10.1007/s005860000186.

  PMID: 10766053 BACKGROUND

• Vaccaro AR, Regan JJ, Crawford AH, Benzel EC, Anderson DG. Complications of pediatric and adult spinal surgery. Chapter 7, Postarthrodesis Adjacent Segment Degeneration, Marcel Dekker, New York, 2004; p 82.

  BACKGROUND

• Andersen MO, Christensen SB, Thomsen K. Outcome at 10 years after treatment for adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2006 Feb 1;31(3):350-4. doi: 10.1097/01.brs.0000197649.29712.de.

  PMID: 16449910 BACKGROUND

• Dolan LA, Weinstein SL. Surgical rates after observation and bracing for adolescent idiopathic scoliosis: an evidence-based review. Spine (Phila Pa 1976). 2007 Sep 1;32(19 Suppl):S91-S100. doi: 10.1097/BRS.0b013e318134ead9.

  PMID: 17728687 BACKGROUND

• Bylski-Austrow DI, Wall EJ, Rupert MP, Roy DR, Crawford AH. Growth plate forces in the adolescent human knee: a radiographic and mechanical study of epiphyseal staples. J Pediatr Orthop. 2001 Nov-Dec;21(6):817-23.

  PMID: 11675562 BACKGROUND

• Wall EJ, Bylski-Austrow DI, Kolata RJ, Crawford AH. Endoscopic mechanical spinal hemiepiphysiodesis modifies spine growth. Spine (Phila Pa 1976). 2005 May 15;30(10):1148-53. doi: 10.1097/01.brs.0000162278.68000.91.

  PMID: 15897828 BACKGROUND

• Bylski-Austrow DI, Wall EJ, Glos DL, Ballard ET, Montgomery A, Crawford AH. Spinal hemiepiphysiodesis decreases the size of vertebral growth plate hypertrophic zone and cells. J Bone Joint Surg Am. 2009 Mar 1;91(3):584-93. doi: 10.2106/JBJS.G.01256.

  PMID: 19255218 BACKGROUND

• Wall EJ, Reynolds JE, Jain VV, Bylski-Austrow DI, Thompson GH, Samuels PJ, Barnett SJ, Crawford AH. Spine Growth Modulation in Early Adolescent Idiopathic Scoliosis: Two-Year Results of Prospective US FDA IDE Pilot Clinical Safety Study of Titanium Clip-Screw Implant. Spine Deform. 2017 Sep;5(5):314-324. doi: 10.1016/j.jspd.2017.02.004.

  PMID: 28882349 DERIVED

Related Links

• Website to contact SpineForm LLC

MeSH Terms

Conditions

Scoliosis; Spinal Curvatures

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Joseph E Reynolds, MBA

  SpineForm LLC

  STUDY DIRECTOR

• Eric J Wall, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2011
• First Posted: November 4, 2011
• Study Start: August 1, 2011
• Primary Completion: December 29, 2017
• Study Completion: December 29, 2017
• Last Updated: February 5, 2018

Record last verified: 2018-02

Locations

US (2)