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Vertebroplasty no better than simulated procedure for pain and disability due to osteoprotic spinal fractures.

Vertebroplasty no better than simulated procedure for pain and disability due to osteoprotic spinal fractures.

Critique date: Tue, 02/09/2010 - 3:51pm
Institution: 
Duke University School of Medicine
   
Article Citation
Citation: 
Kallmes DF, Ccornstock BA, Heagerty PJ, et al. A randomized trial of vertebroplasty for osteoportotic spinal fractures. N Engl J Med 2009;361:569-79.
   
Clinical Bottom Lines

In an elderly, mostly white, female population, vertebroplasty did not improve pain or disability at 1 month more than a carefully simulated procedure.  Both groups demonstrated similar improvement at 3 days and 1 month and complication rates were low.   

   
Methods
Follow-up Period: 
1 month
Setting: 
Medical centers with established vertebroplasty practices and practitioners
Patient Population: 

131 patients (68 intervention/63 control).  Mean age 74, 97% white, 75% female, 47% < high school education.  Low rates of comorbidity (2 on Charlson Index).  Similar duration (16-20 weeks) and intensity (7/10) of pain and disability.  More intervention patients married or living with partner (62% v. 43%).  More control patients reported opioid use (63% v. 56%).

Significant Exclusions: 

Possible neoplasm, active infection, dislocation/retropulsion of bone fragments, difficulty with access or communication (no phone, no English or dementia), recent surgery or bleeding diathesis.

Intervention/Exposure: 

Under conscious sedation, infusion of medical cement (PMMA) into affected vertebral body or simulation procedure with verbal cues, back pressure and odor of PMMA (but no injection).

Outcome Measures: 

Primary: Ratings of disability (modified Roland-Morris Disability Questionnaire—RDQ—0-23) and pain (0-10).  Secondary: Quality of life (SF-36, EQ-5D), ADLs, pain characteristics and opioid use. Intention-to-treat analysis.  Power of 80% to detect 3 pt change in RDQ and 1.5 pt change in pain.

Participant Follow-up: 
67/68 intervention (99%) and 61/63 control (97%).
   
Conclusion
Results: 

Scale

Vertebroplasty

Control

Treatment effect (95% CI)

RDQ  baseline

16.6±3.8

17.5±4.1

 

RDQ  1 month

12.0±6.3

13.0±6.4

0.7 (-1.3 to 2.8)

Pain intensity baseline

6.9±2.0

7.2±1.8

 

Pain intensity 1 month

3.9±2.9

4.6±3.0

0.7 (-0.3 to 1.7)

 

No differences in secondary measures.  Adverse events: 1 vertebroplasty patient with injury to thecal sac and 1 control admitted with tachycardia and rigors.

Concerns Regarding Methodology, Applicability to Older Adults, etc.: 

The study was methodologically sound, but target enrollment was decreased due to difficulty recruiting.  Nonetheless, the investigators achieved adequate power to detect a clinically significant difference and the results were concurrently verified in a companion study.  Of note, comorbidity rates were relatively low and baseline severity of osteoporosis was not reported in this study.

Funding Source and Role: 
Grant funding from NIH. No commercial entity involved.
Created By: 
Mitchell T. Heflin, MD, MHS, Associate Professor of Medicine, Division of Geriatrics, Duke University.
This is a review of the validity of a single study; the ‘bottom lines’ do not reflect comparison with the rest of the literature on this subject.