Report in English with a French summary - KCE

18 Spine technology KCE reports vol.39
3.3.1.4 Data extraction strategy
3.3.2 Results
3.3.2.1 HTA reports
As for clinical trials, information was captured about the study design, number and type
of patients included, intervention, comparator, outcome variables (pain, functional
ability, safety) and results. Information about surrogate endpoints (kyphotic angle,
vertebral height) was not extracted because of the limited importance for patients.
A meta-analysis was performed using the software of Review Manager.
Sixteen completed HTA reports were identified: six concerning balloon kyphoplasty,
seven concerning vertebroplasty, and three concerning both. Above this, three ongoing
projects were found (one concerning balloon kyphoplasty 53 , two concerning
vertebroplasty 54, 55 ). Of the completed HTA reports, one report could not be assessed
because of unavailability of the full-text 56 and another report was excluded because it
was written in Danish 57 . Two reports were not assessed because more recent reports
were found published by the same agency 58, 59 . Two unpublished HTA reports about
kyphoplasty were identified through contacts with Kyphon Inc 60, 61 .
Of the twelve remaining reports, the two unpublished reports were rated as having a
good quality and were included 60, 61 . Four other fair quality reports were also included
in our review 62-65 . Six HTA reports (including the two reports of BCBS and the report
of AHRQ, who used a very poor search strategy) were graded as poor quality reports
and were excluded from further review 66-71 . The quality appraisal of all identified HTA
reports and the evidence tables of the included reports are provided in appendix.
Balloon kyphoplasty
Agencia de Evaluación de Tecnologías Sanitarias HTA report 60
The scope of this unpublished report of good quality was the treatment of osteoporotic
and neoplastic vertebral compression fractures with balloon kyphoplasty. A thorough
literature search until October 2004 identified one systematic review, two HTA
reports, eleven cohort and case-control studies, and 12 case series. The results
indicated significant improvements in pain intensity, functional capacity, and quality of
life. However, the identified evidence demonstrated substantial methodological
limitations and short follow-up periods. The authors concluded that balloon kyphoplasty
can be considered clinically adequate for the treatment of recent and painful vertebral
fractures. However, the authors indicated that there is a particular need for prospective
studies of good methodological quality in order to resolve the uncertainty, and
suggested that patients treated with balloon kyphoplasty should be systematically
included in a prospective clinical study.
University of Birmingham 61
This unpublished report of good quality, which was commissioned by Kyphon Inc.,
focused on the treatment of osteoporotic and neoplastic vertebral compression
fractures with balloon kyphoplasty and vertebroplasty. The literature search (through
March 2004) identified three systematic reviews and a large body of non-randomized
comparative studies and case series. Quality appraisal identified two controlled trials
being little prone to bias 72, 73 . Both procedures were found to have significant
improvements in pain relief, functional capacity, and quality of life, although balloon
kyphoplasty appeared to have a superior adverse event profile. The authors concluded
that both therapies are effective in the management of patients with osteoporotic
vertebral compression fractures that are refractory to conventional medical therapy.
However, they also stressed the need for confirmation of these conclusions by the
results from the ongoing randomized controlled trials.