Prospective Comparative Study to Compare Safety and Effectiveness of Two Vertebral Compression Fracture Reduction Techniques

Osteoporosis Clinical Trial

— SAKOS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02461810
• Other study ID #: SAKOS - EU2014-05
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: February 20, 2018

Study information

• Verified date: February 2019
• Source: Vexim SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: February 20, 2018
• Est. primary completion date: February 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Injuries
• Fractures, Bone
• Fractures, Compression
• Osteoporosis
• Spinal Fractures
• Vertebral Compression Fractures

Intervention

Device:
• Vertebral fracture surgery SpineJack®
Vertebral augmentation for one osteoporotic vertebral compression fracture

Procedure:
• Balloon Kyphoplasty

Locations

Country	Name	City	State
France	Hôpital Jean Minjoz Service Neurochirurgie	Besancon
France	Centre Hospitalier La Cavale Blanche	Brest
France	CHU La Timone	Marseille
France	Hôpital Nord	Marseille
France	CHU Hôtel Dieu Service Neuro traumatologie	Nantes
Germany	Klinik und Poliklinik fur Orthopädie Universitatsklinikum	Bonn
Germany	Loretto-Krankenhaus Freiburg	Freiburg
Germany	Krankenhaus NEUWERK Sankt Augustinus kliniken	Monchengladbach
Italy	Ospedale SS Trinita ASL8	Cagliari
Spain	Hospital Universitario Marques de Valdecilla	Santander
Spain	Hospital Clinico Universitario de Valladolid,	Valladolid
Switzerland	HFR Fribourg - Hôpital cantonal	Fribourg
Switzerland	Clinique Bois-Cerf	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
Vexim SA	ACES Ing.-GmbH

Countries where clinical trial is conducted

France,  Germany,  Italy,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants With Study Success	The primary composite endpoint defines a successful subject if the following components are satisfied (safety and effectiveness): 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,; Maintenance or improvement in function at 12 months from baseline as measured by the 100 point Oswestry Disability Index (ODI) AND,; 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