Treatment of Pelvic Ring Fractures in the Elderly

University Hospital Basel

Status: Terminated

Conditions: Pelvic Pain

Treatments: Procedure: control intervention; Procedure: experimental intervention surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02590783

2015-188

Details and patient eligibility

About

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.

Full description

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

Enrollment: 88 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

experimental intervention surgery

Experimental group

Description:

screw osteosynthesis of the sacrum and in certain cases additional plate osteosynthesis of dislocated pubic rami fractures, postoperative analgesia, physiotherapy, work-up for osteoporosis, geriatric rehabilitation if necessary

Treatment:

Procedure: experimental intervention surgery

control intervention conservative

Active Comparator group

Description:

analgesia, physiotherapy, work-up for osteoporosis, geriatric rehabilitation if necessary

Treatment:

Procedure: control intervention