Clinical trial NCT02591043: Surgical Treatment of Low Energy Pelvic Fractures in the Elderly
Official title: Surgical Treatment of Low Energy Pelvic Ring Fractures in the Elderly: Cross-sectional Single-centre Study From Basel, Switzerland
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fracture
Keywords: Pelvic
Treatment Outcome
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 79
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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)

Primary outcomes:
measure: TUG-Test through study completion, an average of 1 year
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: activity of daily living (ADL) through study completion, an average of 1 year
timeFrame: through study completion, an average of 1 year
measure: Pain test through study completion, an average of 1 year
timeFrame: through study completion, an average of 1 year
measure: Living Situation through study completion, an average of 1 year
timeFrame: through study completion, an average of 1 year
measure: 1-year mortality
timeFrame: one year after surgery
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel-Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Rebecca Hasler, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.