TerminatedPhase 4

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

Stopped: Death of study initiator

Switzerland100 participantsStarted 2015-01

Plain-language 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.

Who can participate

Age range55 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 p…

What they're measuring

Number of new operations within 6 months after vertebroplasty due to adjacent or distant segment fracture.

Timeframe: 6 months after index surgery

Trial details

NCT IDNCT02489825

SponsorUniversity of Bern

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02