Surgical Treatment of Low Energy Pelvic Fractures in the Elderly

Not Applicable

Completed

• Conditions: Fracture
• Interventions: Procedure: Outcome after surgery

• Registration Number: NCT02591043
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-08
• Study First Submitted QC: 2015-10-28
• Study First Posted: 2015-10-29
• Primary Completion: 2016-08
• Status Verified: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-28
• Last Update Posted: 2016-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Follow-up	Outcome after surgery	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.

Primary Outcome Measures

Name	Time	Method
TUG-Test through study completion, an average of 1 year	through study completion, an average of 1 year	TUG test - according test description

Secondary Outcome Measures

Name	Time	Method
activity of daily living (ADL) through study completion, an average of 1 year	through study completion, an average of 1 year	ADL test - according test description
Pain test through study completion, an average of 1 year	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
Living Situation through study completion, an average of 1 year	through study completion, an average of 1 year	Living situation before and after the injury (at home/institutional placement) according test procedure
1-year mortality	one year after surgery

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Basel-Stadt, Switzerland