Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Jul 30;25(1):513.
doi: 10.1186/s13063-024-08350-z.

Conservative or operative therapy in patients with a fragility fracture of the pelvis: study protocol for a prospective, randomized controlled trial

R A Haveman  1   2 , B J M van de Wall  3   4 , M Rohner  3   4 , F J P Beeres  3   4 , P C Haefeli  3   4 , R Baumgärtner  3   4 , R Babst  3   4 , B-C Link  3   4
Affiliations

Conservative or operative therapy in patients with a fragility fracture of the pelvis: study protocol for a prospective, randomized controlled trial

R A Haveman et al. Trials. .

Abstract

Background: The incidence of fragility fractures of the pelvis is rising. Whereas the treatment for FFP type I, III, and IV is clear, the optimal treatment for FFP type II remains a topic of discussion. Traditionally these fractures have been treated conservatively. However, there is a shift toward early surgical stabilization with percutaneous screw fixation to reduce pain and promote mobility in an already frail patient population. High-quality evidence, however, is lacking. Therefore, a randomized clinical trial was designed to compare conservative management to early percutaneous screw fixation in patients with type II fragility fractures.

Methods: This is a monocenter randomized controlled trial. All patients with a FFP type II are screened for inclusion. After obtaining informed consent, patients are randomized between conservative management and surgical stabilization. Conservative management consists of early mobilization under guidance of physiotherapy and analgesics. Patients randomized for surgical treatment are operated on within 72 h using percutaneous screw fixation. The primary endpoint is mobility measured by the DEMMI score. Secondary endpoints are other dimensions of mobility, pain levels, quality of life, mortality, and morbidity. The total follow-up is 1 year. The required sample size is 68.

Discussion: The present study aims to give certainty on the potential benefit of surgical treatment. Current literature on this topic remains unclear. According to the volume of FFP at the study hospital, we assume that the number of patients needed for this study is gathered within 2 years.

Trial registration: ClinicalTrials.gov NCT04744350. Registered on February 8, 2021.

Keywords: Fragility fractures; Mobility; Pelvis; Percutaneous screw fixation; Sacroiliac.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
SPIRIT figure. Schedule of enrollment, intervention, and assessment. *Only applicable for patients randomized for operative treatment
Fig. 2
Fig. 2
Flow diagram
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Hotta K, Kobayashi T. Functional treatment strategy for fragility fractures of the pelvis in geriatric patients. Eur J Trauma Emerg Surg. 2021;47(1):21–7. 10.1007/s00068-020-01484-0 - DOI - PubMed
    1. Rommens PM, Hofmann A. Comprehensive classification of fragility fractures of the pelvic ring: recommendations for surgical treatment. Injury. 2013;44(12):1733–44. 10.1016/j.injury.2013.06.023 - DOI - PubMed
    1. Mendel T, Ullrich BW, Hofmann GO, Schenk P, Goehre F, Schwan S, et al. Progressive instability of bilateral sacral fragility fractures in osteoporotic bone: a retrospective analysis of X-ray, CT, and MRI datasets from 78 cases. Eur J Trauma Emerg Surg. 2021;47(1):11–9. 10.1007/s00068-020-01480-4 - DOI - PubMed
    1. Hopf JC, Krieglstein CF, Muller LP, Koslowsky TC. Percutaneous iliosacral screw fixation after osteoporotic posterior ring fractures of the pelvis reduces pain significantly in elderly patients. Injury. 2015;46(8):1631–6. 10.1016/j.injury.2015.04.036 - DOI - PubMed
    1. Rommens PM, Wagner D, Hofmann A. Minimal invasive surgical treatment of fragility fractures of the pelvis. Chirurgia (Bucur). 2017;112(5):524–37. 10.21614/chirurgia.112.5.524 - DOI - PubMed

Publication types

MeSH terms

Associated data