An interventional study of experimental intervention surgery and control intervention in Pelvic Pain, sponsored by University Hospital, Basel, Switzerland. Terminated at 1 site in Switzerland. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-05-14.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Treatment
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.
Comparison of surgical vs conservative treatment with respect to mobility, pain, morbidity and mortality.
375 studies on the registry are indexed under Pelvic Pain; 83 are open to participants now.
This study's enrollment of 88 is above the median of 54 across 273 interventional studies indexed under Pelvic Pain.
Browse Pelvic Pain studies →University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Procedure: experimental intervention surgery
analgesia, physiotherapy, work-up for osteoporosis, geriatric rehabilitation if necessary
Procedure: control intervention
Patients are placed supine on the carbon table. Screw paths are planned on a spiral CT scan from the sacrum on transversal slices, two Kirschner-wires 2.5 mm in diameter are introduced into the iliac bone through a stab incision and advanced into the ilio-sacral joint, through the lateral part of sacrum into the first and second sacral body, through the contralateral lateral part of the sacrum and exiting the contralateral iliac bone through the sacra-iliac joint with aid of CT-guidance. Over the Kirschner-wires 7.0 mm cannulated screws are introduced and the Kirschner-wires withdrawn. Several low-dose computer tomography scans are performed to secure the correct position. Total radiation dose is 300 mille gray square centimetres (mGycm).
Mobilization guided by our physiotherapists. Full weight bearing is allowed. Analgetic treatment with metamizol, ibuprofen or paracetamol to the attending physicians discretion under regular surveillance laboratory values and/ or morphine or methadone. Patients will be treated with an individually based approach, if necessary involving our anesthesiologic pain service. Thrombo-embolic prophylaxis with a low molecular weight heparin or rivaroxaban for 6 weeks unless there is an indication for oral anticoagulation. All patients will be followed up by the Geriatric Fracture Center considering osteoporosis, fall prophylaxis, malnutrition and delirium. For the duration of the study the patients will not receive Parathyroid Hormone Substitution or Phosphonates.
Mobility at 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.
Time frame: 3 weeks post-diagnosis
Activities of Daily Living (ADL) at baseline
Functional recovery will be measured using the ADL score.
Time frame: baseline
Activities of Daily Living (ADL) at 4-7 days after diagnosis
Functional recovery will be measured using the ADL score.
Time frame: 4-7 days after diagnosis
Activities of Daily Living (ADL) at 3 weeks
Functional recovery will be measured using the ADL score.
Time frame: 3 weeks
Activities of Daily Living (ADL) at 3 months
Functional recovery will be measured using the ADL score.
Time frame: 3 months
Activities of Daily Living (ADL) at 12 months
Functional recovery will be measured using the ADL score.
Time frame: 12 months
Pain (VAS 10) at baseline
Pain will be assessed using the 10 point Visual Analogue Scale (VAS10).
Time frame: baseline
Pain (VAS 10) at 4-7 days after diagnosis
Pain will be assessed using the 10 point Visual Analogue Scale (VAS10).
Time frame: 4-7 days after diagnosis
Pain (VAS 10) at 3 weeks
Pain will be assessed using the 10 point Visual Analogue Scale (VAS10).
Time frame: 3 weeks
Pain (VAS 10) at 3 months
Pain will be assessed using the 10 point Visual Analogue Scale (VAS10).
Time frame: 3 months
Number of patients that are able to return to their pre-injury living situation at 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".
Time frame: 3 months
Number of patients that are able to return to their pre-injury living situation at 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".
Time frame: 12 months
This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland