NCT02461810

Brief Summary

The purpose of this study is to compare the safety and effectiveness of the SpineJack® with the Kyphx Xpander® Inflatable Bone Tamp and support a non-inferiority finding for the use of SpineJack® VCF treatment system versus Balloon Kyphoplasty.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
5 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 3, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2018

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

2.9 years

First QC Date

May 27, 2015

Last Update Submit

February 21, 2019

Conditions

Spinal FracturesVertebral Compression FracturesBack InjuriesOsteoporosis

Outcome Measures

Primary Outcomes (1)

  • Proportion of Participants With Study Success

    The primary composite endpoint defines a successful subject if the following components are satisfied (safety and effectiveness): 1. Reduction in VCF fracture-related pain at 12 months from baseline as measured by a 100 mm VAS scale (reduction of pain at 12 months by \> 20 mm) AND, 2. Maintenance or improvement in function at 12 months from baseline as measured by the 100 point Oswestry Disability Index (ODI) AND, 3. Absence of device-related serious adverse events, defined as device-related adverse events (device migration, recollapse, protrusion) or symptomatic cement extravasation requiring surgical re-intervention or retreatment at the index level, including revision, removal, reoperation, and/or supplemental fixation.

    12 month post-op

Study Arms (2)

SpineJack® system

EXPERIMENTAL

VCF treatment system Vertebral fracture surgery

Device: Vertebral fracture surgery SpineJack®

Balloon Kyphoplasty

ACTIVE COMPARATOR

VCF treatment system Vertebral fracture surgery

Procedure: Balloon Kyphoplasty

Interventions

Vertebral fracture surgery SpineJack®DEVICE

Vertebral augmentation for one osteoporotic vertebral compression fracture

SpineJack® system
Balloon KyphoplastyPROCEDURE
Balloon Kyphoplasty

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female with at least 50 years of age
  • painful VCF which at least meet all following criteria:
  • Fracture due to diagnosed or presumed underlying osteoporosis
  • VCF between T7 and L3
  • Fracture age \<3 months
  • VCF shows loss of height in the anterior, mid or posterior third of the VB from estimated pre-fracture configuration of at least 15% but not more than 40% based on X-Ray at baseline
  • The Index fracture is acute or persistent (not healed), as demonstrated by T2 weighted STIR MRI (or bone scan if patient is contraindicated for MRI)
  • Patient has failed conservative medical therapy, defined as either having a VAS back pain score of ≥50 mm at 6 weeks after initiation of fracture care or a VAS back pain score of ≥70mm at 2 weeks after initiation of fracture care
  • Investigator believes target VB is suitable for SpineJack procedure and Balloon kyphoplasty (e.g., appropriate pedicle diameter) assessed on CT scan pre op
  • Patient has an Oswestry Disability Index (ODI) score of ≥ 30/100
  • Patient is mentally capable and willing to sign a study specific informed consent as documentation of the informed consent process prior to any study procedures
  • The patient is willing and able to comply with all study requirements including follow-up visits and radiographic assessments.

You may not qualify if:

  • Target VCF due to underlying or suspected tumor
  • Target VCF due to high-energy trauma
  • Target VCF is diagnosed as an osteonecrotic fracture
  • Segmental kyphosis of target VB of \>30°
  • Any prior surgical treatment for a vertebral body compression fracture or other surgical procedure on target VB or adjacent level
  • The patient has uncontrolled diabetes
  • Pre-existing or clinically unstable neurologic deficit
  • The patient has spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level to be treated
  • Any physical exam evidence of myelopathy or radiculopathy
  • The patient has pain based on clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis (progressive weakness or paralysis)
  • Patient not able to walk without assistance prior to fracture
  • Any radiographic evidence of pedicle fracture visible on CT scan pre op
  • Spondylolisthesis \>Grade 1 at target VB
  • Any underlying systemic bone disease other than osteoporosis (e.g., osteomalacia, osteogenesis imperfect, Paget's disease, etc.)
  • A medical contraindication to spinal surgery and/or general anesthesia, such as coagulopathy and/or taking warfarin (Coumadin) or other anticoagulant on regular basis for coagulopathy (with a threshold for normal being INR≤1.5, PTT within lab normal range, and platelet count \> 100,000)
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Hôpital Jean Minjoz Service Neurochirurgie

Besançon, France

Location

Centre Hospitalier La Cavale Blanche

Brest, France

Location

CHU La Timone

Marseille, France

Location

Hôpital Nord

Marseille, France

Location

CHU Hôtel Dieu Service Neuro traumatologie

Nantes, France

Location

Klinik und Poliklinik fur Orthopädie Universitatsklinikum

Bonn, Germany

Location

Loretto-Krankenhaus Freiburg

Freiburg im Breisgau, Germany

Location

Krankenhaus NEUWERK Sankt Augustinus kliniken

Mönchengladbach, Germany

Location

Ospedale SS Trinita ASL8

Cagliari, Italy

Location

Hospital Universitario Marques de Valdecilla

Santander, Spain

Location

Hospital Clinico Universitario de Valladolid,

Valladolid, Spain

Location

HFR Fribourg - Hôpital cantonal

Fribourg, Switzerland

Location

Clinique Bois-Cerf

Lausanne, Switzerland

Location

MeSH Terms

Conditions

Spinal FracturesBack InjuriesOsteoporosis

Interventions

Kyphoplasty

Condition Hierarchy (Ancestors)

Spinal InjuriesWounds and InjuriesFractures, BoneBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

VertebroplastyCementoplastyOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Marie-Pierre HONTAS, Director Clinical Affairs

    Vexim SA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2015

First Posted

June 3, 2015

Study Start

April 1, 2015

Primary Completion

February 20, 2018

Study Completion

February 20, 2018

Last Updated

February 22, 2019

Record last verified: 2019-02

Locations

CH(2)FR(5)IT(1)ES(2)DE(3)