Surgical Treatment of Low Energy Pelvic Fractures in the Elderly

Fracture Clinical Trial

— PelvicRetro  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02591043
• Other study ID #: 2015-299
• Status: Completed
• Phase: N/A
• First received: October 8, 2015
• Last updated: September 28, 2016
• Start date: October 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Fracture
• Fractures, Bone

Intervention

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)

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel	Basel-Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TUG-Test through study completion, an average of 1 year	TUG test - according test description	through study completion, an average of 1 year	No
Secondary	activity of daily living (ADL) through study completion, an average of 1 year	ADL test - according test description	through study completion, an average of 1 year	No
Secondary	Pain test 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	No
Secondary	Living Situation 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	No
Secondary	1-year mortality		one year after surgery	No