Clinical trial NCT02590783: Treatment of Pelvic Ring Fractures in the Elderly
Official title: Treatment of Pelvic Ring Fractures in the Elderly: A Randomized Controlled Trial Comparing Surgical vs. Conservative Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pelvic Pain
Keywords: treatment
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 88
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pelvic ring fractures in the elderly are associated with high morbidity during standard conservative treatment due to immobility. Furthermore the risk of long term dependence even after the fracture has united is high. In analogy to the treatment of hip fractures in a similar patient population, patients might benefit from surgical treatment due to a reduction in pain and early mobilization.

Detailed description: Comparison of surgical vs conservative treatment with respect to mobility, pain, morbidity and mortality.

Eligibility criteria: Inclusion Criteria:

* CTI/MRI verified fracture of the sacrum affecting the posterior ring or both posterior and anterior ring
* age\>65 years, ambulatory with/without walking aids before Trauma
* ambulatory with/without walking aids before trauma
* postmenopausal status in women
* informed consent for study participation and surgery

Exclusion Criteria:

* Refusal of consent by the patient or legal representatives to participate in the study
* Other fractures or
* Unstable pelvic fracture (type B or C according to classification of 'Arbeitsgemeinschaft für Osteosynthesefragen' (AO)/OTA) requiring surgical stabilisation after high- or low-energy trauma
* Suspicion of a pathological fracture in the context of known or unknown malignancy
* Previous surgery of the pelvis with metal obstructing the planned paths of the ilio-sacral screws
* Symptomatic low back pain with morphological changes, i.e. intervertebral disc displacement, neoplasm metastasis in the axial skeleton, spinal stenosis, vertebral fracture, spondylarthropathy etc.
* Comorbidity that precludes undergoing general or spinal anaesthesia
* 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 being in a wheel chair)

Primary outcomes:
measure: Mobility at 3 weeks post-diagnosis
timeFrame: 3 weeks post-diagnosis
Secondary outcomes:
measure: Activities of Daily Living (ADL) at baseline
timeFrame: baseline
measure: Activities of Daily Living (ADL) at 4-7 days after diagnosis
timeFrame: 4-7 days after diagnosis
measure: Activities of Daily Living (ADL) at 3 weeks
timeFrame: 3 weeks
measure: Activities of Daily Living (ADL) at 3 months
timeFrame: 3 months
measure: Activities of Daily Living (ADL) at 12 months
timeFrame: 12 months
measure: Pain (VAS 10) at baseline
timeFrame: baseline
measure: Pain (VAS 10) at 4-7 days after diagnosis
timeFrame: 4-7 days after diagnosis
measure: Pain (VAS 10) at 3 weeks
timeFrame: 3 weeks
measure: Pain (VAS 10) at 3 months
timeFrame: 3 months
measure: Number of patients that are able to return to their pre-injury living situation at 3 months
timeFrame: 3 months
measure: Number of patients that are able to return to their pre-injury living situation at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel-Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Marcel Jakob, Prof
role: STUDY_DIRECTOR
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.