Clinical trial NCT02461810: Prospective Comparative Study to Compare Safety and Effectiveness of Two Vertebral Compression Fracture Reduction Techniques
Official title: A Prospective, Multicenter, Randomized, Comparative Clinical Study to Compare the Safety and Effectiveness of Two Vertebral Compression Fracture (VCF) Reduction Techniques: the SpineJack® and the KyphX Xpander® Inflatable Bone Tamp
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Fractures
Vertebral Compression Fractures
Back Injuries
Osteoporosis
Lead sponsor: Vexim SA
Sponsor class: INDUSTRY
Collaborators: name: ACES Ing.-GmbH
First posted: 2015-06-03
Enrollment: 152
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Male or Female with at least 50 years of age
2. 1 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)
3. 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
4. Investigator believes target VB is suitable for SpineJack procedure and Balloon kyphoplasty (e.g., appropriate pedicle diameter) assessed on CT scan pre op
5. Patient has an Oswestry Disability Index (ODI) score of ≥ 30/100
6. 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
7. The patient is willing and able to comply with all study requirements including follow-up visits and radiographic assessments.

Exclusion Criteria:

1. Target VCF due to underlying or suspected tumor
2. Target VCF due to high-energy trauma
3. Target VCF is diagnosed as an osteonecrotic fracture
4. Segmental kyphosis of target VB of \>30°
5. Any prior surgical treatment for a vertebral body compression fracture or other surgical procedure on target VB or adjacent level
6. The patient has uncontrolled diabetes
7. Pre-existing or clinically unstable neurologic deficit
8. The patient has spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level to be treated
9. Any physical exam evidence of myelopathy or radiculopathy
10. The patient has pain based on clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis (progressive weakness or paralysis)
11. Patient not able to walk without assistance prior to fracture
12. Any radiographic evidence of pedicle fracture visible on CT scan pre op
13. Spondylolisthesis \>Grade 1 at target VB
14. Any underlying systemic bone disease other than osteoporosis (e.g., osteomalacia, osteogenesis imperfect, Paget's disease, etc.)
15. 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. Pain due to any other condition that requires daily narcotic medication
17. Disabling back pain due to causes other than acute fracture
18. History of intolerance or allergic reaction to titanium or acrylic compounds
19. Active systemic or local infection at baseline
20. Body mass index \>40
21. Severe cardiopulmonary deficiencies
22. Any other medical illness or condition that, in the investigator's opinion, is likely to impair long-term follow-up (e.g., cancer) or greatly increase the risk of surgery including but not limited to patients with contraindications for general anesthesia (surgeon expertise)
23. Any evidence of alcohol or drug abuse
24. The patient has uncontrolled psychiatric illness or severe dementia
25. The patient is currently on anti-cancer therapy or anti-HIV therapy
26. Patient's life expectancy is less than the study duration or undergoing palliative care
27. Participating in any other investigational study
28. The patient is on long-term steroid therapy (steroid dose ≥ 30 mg /day for \> 3 months)
29. The patient is known to be involved in medical litigation including Workmen's Compensation
30. Patient with contraindication for MRI
31. The patient is pregnant or considering getting pregnant during study participation.

Primary outcomes:
measure: Proportion of Participants With Study Success
timeFrame: 12 month post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: Hôpital Jean Minjoz Service Neurochirurgie
city: Brest
country: France
facility: Centre Hospitalier La Cavale Blanche
city: Marseille
country: France
facility: CHU La Timone
city: Marseille
country: France
facility: Hôpital Nord
city: Nantes
country: France
facility: CHU Hôtel Dieu Service Neuro traumatologie
city: Bonn
country: Germany
facility: Klinik und Poliklinik fur Orthopädie Universitatsklinikum
city: Freiburg
country: Germany
facility: Loretto-Krankenhaus Freiburg
city: Monchengladbach
country: Germany
facility: Krankenhaus NEUWERK Sankt Augustinus kliniken
city: Cagliari
country: Italy
facility: Ospedale SS Trinita ASL8
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid,
city: Fribourg
country: Switzerland
facility: HFR Fribourg - Hôpital cantonal
city: Lausanne
country: Switzerland
facility: Clinique Bois-Cerf
Study officials:
affiliation: Vexim SA
name: Marie-Pierre HONTAS, Director Clinical Affairs
role: STUDY_DIRECTOR
References: