Evaluating Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures

• Sponsor: Centre Hospitalier Universitaire de Nīmes (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01402167
• Collaborator: (none)
• Enrollment: 0
• Arms: 2
• Duration (Months): 23

Study Details

Study Description

Brief Summary

The primary objective of this study is to compare the volume of injected ciment (polymethyl methacrylate) between a group of patients treated with vertebroplasty and a group of patients treated via kyphoplasty. Secondary evaluation will compare the restoration of vertebral height, volume and cyphotic angle between the two techniques, as well as extravation of ciment and functional and quality of life aspects related to these techniques.

Condition or Disease	Intervention/Treatment	Phase
Vertebral Body Compression Fractures	Procedure: Kyphoplasty; Procedure: Vertebroplasty	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluating Transcutaneous Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures: a Randomized Pilot Study Using Catscan Volumetry
• Study Start Date: Sep 1, 2014
• Anticipated Primary Completion Date: May 1, 2016
• Anticipated Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Kyphoplasty Patients randomized to this arm will be treated via balloon kyphoplasty.	Procedure: Kyphoplasty; Patients will be treated via a balloon kyphoplasty surgical procedure
Active Comparator: Vertebroplasty Patients randomized to this arm will be treated via vertebroplasty.	Procedure: Vertebroplasty; Patients will be treated via a transcutaneous vertebroplasty procedure.

Outcome Measures

Primary Outcome Measures

1. The volume (cm^3) of injected ciment [Baseline (Day 0)]

   The volume of injected ciment is measured by catscan extrapolated data.

Secondary Outcome Measures

1. Recovery of vertebral volume (%) [Day 1 to Day 7]

   Recovery of vertebral volume relative to theoretical volume based on neighboring vertebra.

2. Change from baseline of the cyphotic angle (°) [Days 1 to 7]

   The number of degrees of change in the cyphotic angle of the corrected vertebra relative to baseline measurement (°)

3. Change from baseline of the cyphotic angle (°) [1 month]

   The number of degrees of change in the cyphotic angle of the corrected vertebra relative to baseline measurement (°)

4. Change from baseline of the cyphotic angle (°) [3 months]

   The number of degrees of change in the cyphotic angle of the corrected vertebra relative to baseline measurement (°)

5. Change from baseline in vertebral height (mm) [Days 1 to 7]

   Change in vertebra height (mm) before and after surgery

6. Change from baseline in vertebral height (mm) [1 month]

   Change in vertebra height (mm) before and after surgery

7. Change from baseline in vertebral height (mm) [3 months]

   Change in vertebra height (mm) before and after surgery

8. Volume of ciment leakage (cm^3) [Day 1]

   The volume of ciment leakage will be determined according to catscan data.

9. Change in Visual Analog Scale (0 to 10) for pain before and after surgery [Day 0 (post-op)]

   Brute change in Visual Analog Scale (0 to 10) for pain before and after surgery

10. Change in Visual Analog Scale (0 to 10) for pain before and after surgery [1 month]

    Brute change in Visual Analog Scale (0 to 10) for pain before and after surgery

11. Change in Visual Analog Scale (0 to 10) for pain before and after surgery [3 months]

    Brute change in Visual Analog Scale (0 to 10) for pain before and after surgery

12. % Change in Visual Analog Scale (0 to 10) for pain before and after surgery [Day 0 (post-op)]

    The percentage change (%) in Visual Analog Scale (0 to 10) for pain before and after surgery

13. % Change in Visual Analog Scale (0 to 10) for pain before and after surgery [1 month]

    The percentage change (%) in Visual Analog Scale (0 to 10) for pain before and after surgery

14. % Change in Visual Analog Scale (0 to 10) for pain before and after surgery [3 months]

    The percentage change (%) in Visual Analog Scale (0 to 10) for pain before and after surgery

15. The change in the ODI score before and after surgery [3 months]

    The change in the Oswestry Disability Index before and after surgery

16. The % change in the ODI score before and after surgery [3 months]

    The percentage change (%) in the Oswestry Disability Index before and after surgery

17. Change in SF-36 quality of life score before and after surgery [1 month]

    Change in SF-36 quality of life score before and after surgery

18. Change in SF-36 quality of life score before and after surgery [3 months]

    Change in SF-36 quality of life score before and after surgery

19. The % change in SF-36 quality of life score before and after surgery [1 month]

    Percentage change (%) in SF-36 quality of life score before and after surgery

20. The % change in SF-36 quality of life score before and after surgery [3 months]

    Percentage change (%) in SF-36 quality of life score before and after surgery

21. Change in FABQ score before and after surgery [1 month]

    Change in the Fear-Avoidance Beliefs Questionnaire score before and after surgery

22. Change in FABQ score before and after surgery [3 months]

    Change in the Fear-Avoidance Beliefs Questionnaire score before and after surgery

23. % Change in FABQ score before and after surgery [1 month]

    Percentage change (%) in the Fear-Avoidance Beliefs Questionnaire score before and after surgery

24. % Change in FABQ score before and after surgery [3 months]

    Percentage change (%) in the Fear-Avoidance Beliefs Questionnaire score before and after surgery

25. Change in DPQ score before and after surgery [1 month]

    Change in the Dallas Pain Questionnaire score before and after surgery

26. Change in DPQ score before and after surgery [3 months]

    Change in the Dallas Pain Questionnaire score before and after surgery

27. % Change in DPQ score before and after surgery [3 months]

    Percentage change (%) in the Dallas Pain Questionnaire score before and after surgery

28. % Change in DPQ score before and after surgery [1 month]

    Percentage change (%) in the Dallas Pain Questionnaire score before and after surgery

29. Duration of surgery (minutes) [Day 0 (day of surgery)]

    Length of operative time (minutes)

30. Presence / absence of per-operative complications [Day 0 (day of surgery)]

    Presence / absence of per-operative complications

31. Presence / absence of post-operative complications [1 month]

    Presence / absence of post-operative complications

32. Presence / absence of post-operative complications [3 months]

    Presence / absence of post-operative complications

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• The patient must have given his/her informed and signed consent

• The patient must be insured or beneficiary of a health insurance plan

• The patient is available for 3 months of follow-up

• Fracture type according to Magerl Classification (1994) must be one of the following: A1, A2.1, A3.1, A3.2

• Cyphose of >10°

• Spinal pain

• Vertebral fracture < 3 weeks old located between D5 and L5

• If fragments in the canal, they must protrude less than 40%

• Absence of other lesions, including cancer

Exclusion Criteria:

• The patient is participating in another study

• The patient is in an exclusion period determined by a previous study

• The patient is under judicial protection, under tutorship or curatorship

• The patient refuses to sign the consent

• It is impossible to correctly inform the patient

• Patient cannot read French

• Patient is pregnant or breast feeding

• Patient has a fracture on an adjacent vertebra

• Patient has a contra-indication for a treatment used in this study

• ASA class IV or V

• Patient has a neurological deficit

• Previous spinal surgery

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nīmes

Investigators

• Principal Investigator: Pascal Kouyoumdjian, MD, Centre Hospitalier Universitaire de Nîmes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• ClinicalTrials.gov Identifier: NCT01402167
• Other Study ID Numbers: LOCAL/2011/PK-04
• First Posted: Jul 26, 2011
• Last Update Posted: Mar 25, 2015
• Last Verified: Mar 1, 2015

• Additional relevant MeSH terms: Fractures, Bone; Fractures, Compression

Study Results

No Results Posted as of Mar 25, 2015