Surgical Treatment of Low Energy Pelvic Fractures in the Elderly (PelvicRetro)

September 28, 2016 updated by: University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4031
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Follow-up
Patients have not received a structured follow up examination or evaluation of outcome after surgery. Therefore this study aims at conducting a follow up examination regarding functional outcome, pain and radiologic healing in these patients.
Procedure: Outcome after surgery
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 1 year
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
through study completion, an average of 1 year
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
through study completion, an average of 1 year
1-year mortality
Time Frame: one year after surgery
one year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Rebecca Hasler, Dr, University Hospital, Basel, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

October 8, 2015

First Submitted That Met QC Criteria

October 28, 2015

First Posted (Estimate)

October 29, 2015

Study Record Updates

Last Update Posted (Estimate)

September 29, 2016

Last Update Submitted That Met QC Criteria

September 28, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-299

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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