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Completed

NCT Number: NCT02591043

Surgical Treatment of Low Energy Pelvic Fractures in the Elderly

Since May 2010 the Department of Trauma, Basel University Hospital has performed surgical stabilisation of the posterior pelvic ring on 55 patients. These patients have not received a structured follow up examination or evaluation of outcome after surgery.

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Key information

Conditions

Fracture Fractures, Bone Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

About this study

Functional outcome of elderly patients with surgical treatment of low energy pelvic ring fractures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elderly patients (age ≥55y ears) of any ethnic / sociodemographic background
  • Pelvic ring fracture after low energy trauma affecting the posterior ring or both (posterior and anterior ring)
  • Surgical stabilisation of the pelvic ring at Basel University Hospital between May 2010 and December 2014
  • Ambulatory before surgery
  • Informed consent for study participation by the patient or legal representatives

Exclusion criteria

  • Refusal of consent by the patient or legal representatives to participate in the study
  • Fractures within the last 3 months before follow-up
  • Suspicion of a pathological fracture in the context of known or unknown malignancy
  • Symptomatic low back pain with morphological changes, i.e. intervertebral disc displacement, neoplasm metastasis in the axial skeleton, spinal stenosis, vertebral fracture, spondylarthropathy etc.
  • Pre-trauma mobility status that precludes achieving a post-trauma mobility status enabling the patient to perform the timed up and go test (e.g. patient in a wheel chair)

Treatment and study plan

Outcome after surgery

Procedure

Functional outcome after surgical treatment of pelvic ring fractures Measurements: TUG-test score, ADLs index, maximal pain (VAS 1-10) at rest and experienced during TUG-test. One-year mortality, signs of healing, dislocation or other complications on anterior-posterior radiographs of the pelvis, living situation before and after the injury (at home/institutional placement)

Primary outcomes

  1. TUG-Test through study completion, an average of 1 year

    Time frame: through study completion, an average of 1 year

    TUG test - according test description

Secondary outcomes

  1. activity of daily living (ADL) through study completion, an average of 1 year

    Time frame: through study completion, an average of 1 year

    ADL test - according test description

  2. Pain test through study completion, an average of 1 year

    Time frame: through study completion, an average of 1 year

    Maximal pain (VAS 1-10) experienced during TUG-test and at rest at the day of follow up

  3. Living Situation through study completion, an average of 1 year

    Time frame: through study completion, an average of 1 year

    Living situation before and after the injury (at home/institutional placement) according test procedure

  4. 1-year mortality

    Time frame: one year after surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Surgical Treatment of Low Energy Pelvic Ring Fractures in the Elderly: Cross-sectional Single-centre Study From Basel, Switzerland

Acronym: PelvicRetro

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 29, 2015
Registry last updated
Sep 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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