# INvestigative Kyphoplasty Efficacy and Safety Trial (INKTEST)

> **NIH NIH R34** · MAYO CLINIC ROCHESTER · 2021 · $186,577

## Abstract

PROJECT ABSTRACT
The long-term objective of this project is to improve the care of patients suffering from osteoporotic
compression fractures, which occurs in up to 700,000 US patients per year. These painful fractures are a
leading cause of back pain-related morbidity and mortality. Historically these fractures were treated with bed
rest, bracing, and narcotic analgesics. The advent of spine augmentation, i.e., the percutaneous injection of
medical cement into painful fractures, in the 1990s has been considered a watershed event in the care of these
patients. The procedure, done either as a simple needle infusion (termed “vertebroplasty”) or with temporary
balloon inflation (termed “KKyphoplasty”), has been shown in numerous case series to offer remarkable relief
of pain.
Unblinded randomized controlled trials (RCTs) of both vertebroplasty and Kyphoplasty confirmed these earlier
results, showing benefit of spine augmentation over medical therapy. However, four independent, blinded,
placebo controlled trials of vertebroplasty no benefit of over a “simulated” procedure without cement infusion.
Unlike vertebroplasty, Kyphoplasty has never been evaluated in a blinded trial. In the aftermath of the “sham”
vertebroplasty trials, the number of vertebroplasty procedures performed in the US plummeted, while
Kyphoplasty procedures have actually increased over time. Numerous investigators have proposed that
Kyphoplasty is superior to vertebroplasty, but numerous RCTs comparing the two procedures have shown
relative equivalence in outcomes. As such, it remains unknown whether Kyphoplasty would offer benefit over a
"simulated" augmentation, where vertebroplasty did not.
In this grant application, we will make plans to carry out a future randomized, controlled trial of Kyphoplasty
versus a “control intervention,” where Kyphoplasty is simulated but no cement infused. This type of study
design will allow us to determine whether the observed benefit of Kyphoplasty is related to the balloon inflation
and cement infusion or to other factors that include patient expectation of benefit (i.e., the “placebo effect”).

## Key facts

- **NIH application ID:** 10205238
- **Project number:** 1R34AR079098-01
- **Recipient organization:** MAYO CLINIC ROCHESTER
- **Principal Investigator:** JEFFREY G JARVIK
- **Activity code:** R34 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $186,577
- **Award type:** 1
- **Project period:** 2021-09-01 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10205238

## Citation

> US National Institutes of Health, RePORTER application 10205238, INvestigative Kyphoplasty Efficacy and Safety Trial (INKTEST) (1R34AR079098-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10205238. Licensed CC0.

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