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Conservative or Operative Therapy in Patients With a Fragility Fracture of the Pelvis

NCT04744350 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2023-10-03

No results posted yet for this study

Summary

In our society the population consists of more elderly patients. Medical treatment needs to be adjusted to this patient group. This research project focusses on patients with a fragility fracture of the pelvis. This results from a minor trauma and can cause a long immobilization period because of severe pain. For FFP type II b and II c there is no consensus on the best treatment option. Either a surgical minimal invasive sacroiliac osteosynthesis or conservative treatment is a possibility. Of course, both treatment options have pros and cons. This research project will randomize all patients with a FFP IIb or IIc fracture in either surgical or conservative treatment. These treatments will be evaluated at the follow-ups, 4 weeks, 4 months and 1 year after trauma. This will be evaluated with the DEMMI, Accelerometer, EQ-5D (EuroQol Quality of Live Questionnaire), radiological results, range of motion, pain-levels and reporting any postoperative complications or adverse events. Patient will be included over a period of 18 months and will be followed for at least a year. This research project aim to answer the question which treatment option for FFP type IIb and IIc is the most adequate.

Conditions

  • Pelvic Fracture

Interventions

PROCEDURE

Treatment of FFP type IIb and IIc

Patients will either be randomized in the surgical or conservative group.

Sponsors & Collaborators

  • Björn-Christian Link

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2024-12-30
Completion
2025-12-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04744350 on ClinicalTrials.gov