Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study About the Effect of Preventive Adjacent Level Cement Augmentation After Osteoporotic Vertebral Compression Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02489825
Recruitment Status : Recruiting
First Posted : July 3, 2015
Last Update Posted : September 6, 2017
Sponsor:
Collaborator:
Sonnenhof Hospital, Bern
Information provided by (Responsible Party):
University of Bern

Brief Summary:
Vertebroplasty itself is challenged regarding its clinical efficacy. While two randomized controlled trials (RCTs) with substantial methodological problems have led to an intense discussion another RCT with larger case numbers, more representative inclusion criteria and a more consistent and sound methodology has revealed results that mirror the investigators' own clinical experience. In their daily practice, the investigators have further advanced their treatment concept and routinely apply prophylactic augmentations with VP using an algorithm. Biomechanical studies support their approach, but clinical studies are rare so far. Prophylactic augmentation with balloon kyphoplasty has not shown convincing effects in a small pilot study. Given the above mentioned methodological and clinical disputes and the call for high-evidence studies about VP, the investigators aim at generating a reliable sample size calculation and preliminary results for a future multicenter RCT about prophylactic adjacent level augmentation with VP in single level osteoporotic compression fractures.

Condition or disease Intervention/treatment Phase
Osteoporosis Vertebral Fracture Procedure: Augmentation vertebroplasty Procedure: Augmentation and prophylactic vertebroplasty Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study: Does Preventive Adjacent Level Cement Augmentation Positively Affect Reoperation Rates After Osteoporotic Vertebral Compression Fractures?
Study Start Date : January 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Augmentation vertebroplasty
Single level fracture fixation with vertebroplasty
Procedure: Augmentation vertebroplasty
Cement augmentation of fractured vertebral body

Augmentation and prophylactic vertebroplasty
Triple level augmentation with VP fixation of the fracture and additional prophylactic vertebroplasty in both the adjacent levels
Procedure: Augmentation and prophylactic vertebroplasty
Cement augmentation of fractured vertebral body and prophylactic augmentation of both adjacent vertebral bodies




Primary Outcome Measures :
  1. Number of new operations within 6 months after vertebroplasty due to adjacent or distant segment fracture. [ Time Frame: 6 months after index surgery ]
    Measured by interview, clinical & radiographic assessment


Secondary Outcome Measures :
  1. Disease specific quality of life (COMI back form) [ Time Frame: 6 months after index surgery ]
    Measured by questionnaire

  2. General quality of life [ Time Frame: 6 months after index surgery ]
    Measured by questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 55 years
  • Written informed consent
  • Single level acute (< 6 weeks) vertebral compression fracture
  • Fracture due to diagnosed or presumed underlying primary or secondary osteoporosis
  • Patients with Association for the study of Osteosynthesis (AO) type A1.x fractures and A3.1 fractures may be included in the study
  • Target Vertebral Compression Fracture (VCF) is between T10 and L4
  • Target VCF to be treated shows either: height change - an acute (< 6 weeks) change in VB height (>15% height loss) with height loss at the anterior or middle portion of the VB consistent with a worsening of 1 or more grades acc to Genant
  • OR positive MRI or bone scan - VB shows hyperintense signal on MRI-T2 or STIR sequence
  • OR target VB is positive on radionuclide bone scan
  • Back pain correlating with the location of the VCF
  • Treatment of target and adjacent VCFs is technically feasible by and clinically appropriate for vertebroplasty
  • No previous VCFs
  • No major surgery of the spine planned for at least 6 months following enrollment
  • Pre-treatment back pain by numerical rating scale (NRS) score > 4 (0-10 scale)
  • Subject is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent
  • Psychosocially, mentally and physically able to fully comply with the protocol requirements for the duration of the study including adhering to scheduled visits, treatment plan, completing forms and other study procedures.

Exclusion Criteria

  • VB morphology or configuration is such that vertebroplasty is not technically feasible for the targeted and adjacent VCFs
  • Fracture due to high-energy trauma
  • Suspected OR proven cancer inside index vertebral body
  • Disabling back pain due to causes other than acute fracture (e.g., sacroiliac fracture, symptomatic degenerative disc disease, lumbar spinal stenosis)
  • Any painful VCF with fracture age > 6 weeks
  • Patients with primary tumors of the bone (e.g., osteosarcoma) or solitary plasmacytoma at site of the index or adjacent VCF
  • Any objective evidence of neurologic compromise at baseline.
  • Previous balloon kyphoplasty, VBS or vertebroplasty for any VCF
  • Significant clinical comorbidity that may potentially interfere with follow-up (e.g., dementia, severe comorbid illness)
  • Patients requiring the use of high-dose steroid (>= 100mg prednisone or 20 mg dexamethasone per day), IV pain medication, or nerve block to control chronic back pain unrelated to index VCF
  • Spinal cord compression or canal compromise requiring decompression
  • Patients with osteoblastic tumors at the site of the index VCF
  • MRI contraindication (e.g. cerebral aneurysm clips, pacemaker, implanted biostimulators, cochlear implants, penile prosthesis)
  • Spinal instability as indicated by neurologic deficit, kyphosis >30°, compression >50%, translation >4 mm, interspinous-process widening.
  • Pre-existing conditions contrary to vertebroplasty, such as: irreversible coagulopathy or bleeding disorder
  • Allergy to bone cement.
  • Any evidence of VB or systemic infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02489825


Contacts
Layout table for location contacts
Contact: Michèle Damaskinos +41 31 358 12 79 micheledamaskinos@sonnenhof.ch
Contact: Paul Heini, MD, professor, head of dept. +41 31 358 17 90 wirbelsaeule@sonnenhof.ch

Locations
Layout table for location information
Switzerland
Sonnenhof hospital, dept. of spinal surgery Recruiting
Bern, Switzerland, 3006
Principal Investigator: Paul Heini, MD, professor, head of dept.         
Sponsors and Collaborators
University of Bern
Sonnenhof Hospital, Bern
Investigators
Layout table for investigator information
Principal Investigator: Paul Heini, MD, professor, head of dept. Sonnenhof Hospital, Bern

Publications of Results:
Layout table for additonal information
Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT02489825     History of Changes
Other Study ID Numbers: 008/13
13-01-F ( Other Grant/Funding Number: Lindenhofstiftung Bern )
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017

Keywords provided by University of Bern:
randomized controlled trial
vertebral fracture
osteoporosis
vertebroplasty
augmentation

Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoporosis
Fractures, Bone
Spinal Fractures
Fractures, Compression
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Spinal Injuries
Back Injuries