Treatment of Pelvic Ring Fractures in the Elderly

Not Applicable

Terminated

• Conditions: Pelvic Pain
• Interventions: Procedure: experimental intervention surgery; Procedure: control intervention

• Registration Number: NCT02590783
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study First Submitted: 2015-09-22
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-29
• Study Start: 2017-10-17
• Primary Completion: 2022-07-11
• Study Completion: 2022-07-11
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 88

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental intervention surgery	experimental intervention surgery	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
control intervention conservative	control intervention	analgesia, physiotherapy, work-up for osteoporosis, geriatric rehabilitation if necessary

Primary Outcome Measures

Name	Time	Method
Mobility at 3 weeks post-diagnosis	3 weeks post-diagnosis	Quality of mobilization will be compared using the TUG test. The primary endpoint is TUG at 3 weeks following diagnosis (+/- 3 days) all TUG measurements are assessed by the study nurse.

Secondary Outcome Measures

Name	Time	Method
Number of patients that are able to return to their pre-injury living situation at 12 months	12 months	Number of patients that are able to return to their pre-injury living Situation. The outcome to compare the "return to the pre-injury living situation".
Activities of Daily Living (ADL) at 3 months	3 months	Functional recovery will be measured using the ADL score.
Activities of Daily Living (ADL) at baseline	baseline	Functional recovery will be measured using the ADL score.
Activities of Daily Living (ADL) at 4-7 days after diagnosis	4-7 days after diagnosis	Functional recovery will be measured using the ADL score.
Pain (VAS 10) at 3 weeks	3 weeks	Pain will be assessed using the 10 point Visual Analogue Scale (VAS10).
Activities of Daily Living (ADL) at 12 months	12 months	Functional recovery will be measured using the ADL score.
Activities of Daily Living (ADL) at 3 weeks	3 weeks	Functional recovery will be measured using the ADL score.
Pain (VAS 10) at baseline	baseline	Pain will be assessed using the 10 point Visual Analogue Scale (VAS10).
Pain (VAS 10) at 4-7 days after diagnosis	4-7 days after diagnosis	Pain will be assessed using the 10 point Visual Analogue Scale (VAS10).
Number of patients that are able to return to their pre-injury living situation at 3 months	3 months	Number of patients that are able to return to their pre-injury living Situation. The outcome to compare the "return to the pre-injury living situation".
Pain (VAS 10) at 3 months	3 months	Pain will be assessed using the 10 point Visual Analogue Scale (VAS10).

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Basel-Stadt, Switzerland