Surgical Treatment of Low Energy Pelvic Fractures in the Elderly

NCT ID: NCT02591043

Last Updated: 2016-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-09-30

Brief Summary

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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

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

Conditions

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Fracture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Outcome after surgery

Intervention Type 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)

Interventions

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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)

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca Hasler, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

References

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Rommens PM, Hofmann A. Comprehensive classification of fragility fractures of the pelvic ring: Recommendations for surgical treatment. Injury. 2013 Dec;44(12):1733-44. doi: 10.1016/j.injury.2013.06.023. Epub 2013 Jul 18.

Reference Type BACKGROUND
PMID: 23871193 (View on PubMed)

Other Identifiers

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2015-299

Identifier Type: -

Identifier Source: org_study_id

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