Treatment of Pelvic Ring Fractures in the Elderly

Treatment of Pelvic Ring Fractures in the Elderly: A Randomized Controlled Trial Comparing Surgical vs. Conservative Therapy

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.

Study Overview

• Status: Terminated
• Conditions: Pelvic Pain
• Intervention / Treatment: Procedure: experimental intervention surgery; Procedure: control intervention

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4021
      • University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: experimental intervention surgery; 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).
Active Comparator: control intervention conservative; analgesia, physiotherapy, work-up for osteoporosis, geriatric rehabilitation if necessary	Procedure: control intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 weeks post-diagnosis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activities of Daily Living (ADL) at baseline	Functional recovery will be measured using the ADL score.	baseline
Activities of Daily Living (ADL) at 4-7 days after diagnosis	Functional recovery will be measured using the ADL score.	4-7 days after diagnosis
Activities of Daily Living (ADL) at 3 weeks	Functional recovery will be measured using the ADL score.	3 weeks
Activities of Daily Living (ADL) at 3 months	Functional recovery will be measured using the ADL score.	3 months
Activities of Daily Living (ADL) at 12 months	Functional recovery will be measured using the ADL score.	12 months
Pain (VAS 10) at baseline	Pain will be assessed using the 10 point Visual Analogue Scale (VAS10).	baseline
Pain (VAS 10) at 4-7 days after diagnosis	Pain will be assessed using the 10 point Visual Analogue Scale (VAS10).	4-7 days after diagnosis
Pain (VAS 10) at 3 weeks	Pain will be assessed using the 10 point Visual Analogue Scale (VAS10).	3 weeks
Pain (VAS 10) at 3 months	Pain will be assessed using the 10 point Visual Analogue Scale (VAS10).	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".	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".	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Study Director: Marcel Jakob, Prof, University Hospital, Basel, Switzerland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2017
• Primary Completion (Actual): July 11, 2022
• Study Completion (Actual): July 11, 2022

Study Registration Dates

• First Submitted: September 22, 2015
• First Submitted That Met QC Criteria: October 27, 2015
• First Posted (Estimated): October 29, 2015

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: treatment
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pelvic Pain
• Other Study ID Numbers: 2015-188

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No