The published evidence
What the studies show — and what each one selected for.
44% vs 21%
Patients who reached mild pain two weeks after treatment, versus after a placebo
procedure, in VAPOUR — the double-blind, placebo-controlled trial that enrolled only
fresh (under six weeks) and severe (7 out of 10 or worse) fractures. More than twice as
likely, and the advantage held at six months.¹
60 days
Extra days free of bed rest and restricted activity gained by balloon-kyphoplasty
patients in the FREE trial — 300 patients, 21 centres, the largest randomized test of
kyphoplasty itself. Physical function was significantly better at one month and held
through six.² ⁵
Under 4 weeks
In a 2025 meta-analysis, kyphoplasty done within four weeks of the fracture gave
significantly better pain relief and better correction of the wedge angle than
kyphoplasty done later. “Sooner” is not a sales pitch on this page. It’s
the finding.³
Under 1%
Major complications across the randomized trials, with no procedure-related deaths
— and fewer cement leaks with kyphoplasty’s balloon than with the older
technique.⁵
Start with what the evidence is: vertebral augmentation — kyphoplasty
and its older cousin, vertebroplasty — has been studied for more than thirty years, and
the research has sharpened over time toward one conclusion: the people who benefit most are
the ones with severe pain from a recent fracture, treated within about six weeks. That is who
the strongest trials enrolled, and it is who we treat. It is why national bodies and the
medical societies — NICE in the UK, the American College of Radiology, the neurosurgical
societies, the American Academy of Family Physicians and the interventional radiology
societies among them — advise vertebral augmentation for painful osteoporotic
compression fractures.⁵ ⁶ ⁷ You may read that some older studies found no
benefit; those studies mixed fresh fractures with months-old, already-healing ones. The
newer, better-selected trials came out the other way.⁵
The transparent half: in VAPOUR, fewer than half of the treated patients
had reached mild pain at two weeks — more than twice the placebo group, but not
everyone.¹ FREE compared kyphoplasty with usual care rather than with a placebo
procedure, so we lean on VAPOUR’s blinded numbers for the headline and on FREE for what
it measured best — function, days out of bed, and the shape of the bone at two
years.² And the evidence fades for older fractures that have already begun to heal
— which is why it is the first limit on this page.
And the other side of the ledger — what waiting costs. In VAPOUR,
nearly half of the untreated fractures had lost more height by six months, and hospitalized
patients who were treated went home about five and a half days sooner.¹ ⁵ In
another trial, every treated patient was up and walking within 24 hours, against 2% of those
managed with rest and medication.⁵ And bed rest is not free: as little as two days of it
starts measurable bone loss, and ten days costs about 15% of an older adult’s strength
and stamina — roughly what ten years of ageing takes.⁵
What we won’t claim: a 90% number, a change you’ll see in the
mirror, or that a procedure on one bone treats the osteoporosis in the rest. What we will
say: for a fresh, severe compression fracture, kyphoplasty is a real option with real
evidence, a clean safety record across the trials, and it takes nothing off the table
— the bone-health plan, and time itself, remain exactly as available afterward.
Sources: 1. Clark et al., VAPOUR,
Lancet 2016 — multicentre, randomised, double-blind, placebo-controlled;
120 patients with 1–2 osteoporotic fractures <6 weeks old and pain ≥7/10; primary
outcome pain <4/10 at 14 days: 24/61 (44%) vs 12/59 (21%), p=0.011, durable to 6 months;
median admission shortened 5.5 days; 30% greater vertebral height preservation vs sham; mean
cement volume 7.5 mL. 2. Wardlaw et al., FREE, Lancet 2009 — 300
patients, 21 sites, 1–3 acute fractures, balloon kyphoplasty vs non-surgical care; SF-36
Physical Component Summary difference 5.2 points at 1 month (95% CI 2.9–7.4, p<0.001),
durable to 6 months; 60 days gained without restricted activity/bed rest; adverse-event frequency
did not differ; 2-year follow-up (Boonen et al. 2011): durable back-pain reduction; 27% anterior
height restoration and 3.3° kyphosis correction maintained. 3. Time to balloon kyphoplasty,
systematic review with meta-analysis, N Am Spine Soc J 2025 — <4 weeks vs
>4 weeks: better pain scores and kyphotic-angle correction. 4. Network meta-analysis of 23 RCTs /
2,838 patients, Eur Radiol 2024 — adjacent-level fracture, kyphoplasty vs natural
history RR 1.35 (95% CI 0.78–2.34), p=0.23. 5. Chandra RV, Maingard J, Asadi H, et al.
Vertebroplasty and kyphoplasty for osteoporotic vertebral fractures: what are the latest data?
AJNR Am J Neuroradiol 2018;39:798–806 — review of the randomized trials,
claims data and society positions; source for: bed-rest costs (bone loss from 2 days; 15% aerobic
capacity/strength lost after 10 days ≈ 10 years of ageing), VAPOUR height preservation,
admission and cement-volume data, FREE 2-year anatomic outcomes, Farrokhi 2011 (100% vs 2%
ambulatory at 24 h), major complications <1% with no procedural mortality across the RCTs
(one symptomatic leak requiring surgery), lower cement-leak rate and greater kyphosis correction
with kyphoplasty (2,838-patient meta-analysis), sham-arm height loss in ~50% by 6 months, and the
NICE / 2014 society / CIRSE positions. 6. Barr JD, Jensen ME, Hirsch JA, et al. Position statement
on percutaneous vertebral augmentation — SIR, AANS/CNS, ACR, ASNR, ASSR, CIRA, SNIS. J
Vasc Interv Radiol 2014;25:171–181. 7. NICE Technology Appraisal TA279 (2013):
percutaneous vertebroplasty and percutaneous balloon kyphoplasty for treating osteoporotic
vertebral compression fractures. Sources 1, 2, 5 full text or abstract verified; 3, 4, 6, 7 via
secondary summaries — full texts before any print or ad use.