Treatment of Pelvic Ring Fractures in the Elderly
Primary Purpose
Pelvic Pain
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
experimental intervention surgery
control intervention
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Pain focused on measuring treatment
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)
Sites / Locations
- University Hospital BaselRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
experimental intervention surgery
control intervention conservative
Arm 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
analgesia, physiotherapy, work-up for osteoporosis, geriatric rehabilitation if necessary
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Activities of Daily Living (ADL) at baseline
Functional recovery will be measured using the ADL score.
Activities of Daily Living (ADL) at 4-7 days after diagnosis
Functional recovery will be measured using the ADL score.
Activities of Daily Living (ADL) at 3 weeks
Functional recovery will be measured using the ADL score.
Activities of Daily Living (ADL) at 3 months
Functional recovery will be measured using the ADL score.
Activities of Daily Living (ADL) at 12 months
Functional recovery will be measured using the ADL score.
Pain (VAS 10) at baseline
Pain will be assessed using the 10 point Visual Analogue Scale (VAS10).
Pain (VAS 10) at 4-7 days after diagnosis
Pain will be assessed using the 10 point Visual Analogue Scale (VAS10).
Pain (VAS 10) at 3 weeks
Pain will be assessed using the 10 point Visual Analogue Scale (VAS10).
Pain (VAS 10) at 3 months
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
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".
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".
Full Information
NCT ID
NCT02590783
First Posted
September 22, 2015
Last Updated
November 24, 2021
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT02590783
Brief Title
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
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2015 (undefined)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Pain
Keywords
treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
233 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental intervention surgery
Arm Type
Experimental
Arm 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
Arm Title
control intervention conservative
Arm Type
Active Comparator
Arm Description
analgesia, physiotherapy, work-up for osteoporosis, geriatric rehabilitation if necessary
Intervention Type
Procedure
Intervention Name(s)
experimental intervention surgery
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
control intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mobility at 3 weeks post-diagnosis
Description
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
Secondary Outcome Measure Information:
Title
Activities of Daily Living (ADL) at baseline
Description
Functional recovery will be measured using the ADL score.
Time Frame
baseline
Title
Activities of Daily Living (ADL) at 4-7 days after diagnosis
Description
Functional recovery will be measured using the ADL score.
Time Frame
4-7 days after diagnosis
Title
Activities of Daily Living (ADL) at 3 weeks
Description
Functional recovery will be measured using the ADL score.
Time Frame
3 weeks
Title
Activities of Daily Living (ADL) at 3 months
Description
Functional recovery will be measured using the ADL score.
Time Frame
3 months
Title
Activities of Daily Living (ADL) at 12 months
Description
Functional recovery will be measured using the ADL score.
Time Frame
12 months
Title
Pain (VAS 10) at baseline
Description
Pain will be assessed using the 10 point Visual Analogue Scale (VAS10).
Time Frame
baseline
Title
Pain (VAS 10) at 4-7 days after diagnosis
Description
Pain will be assessed using the 10 point Visual Analogue Scale (VAS10).
Time Frame
4-7 days after diagnosis
Title
Pain (VAS 10) at 3 weeks
Description
Pain will be assessed using the 10 point Visual Analogue Scale (VAS10).
Time Frame
3 weeks
Title
Pain (VAS 10) at 3 months
Description
Pain will be assessed using the 10 point Visual Analogue Scale (VAS10).
Time Frame
3 months
Title
Number of patients that are able to return to their pre-injury living situation at 3 months
Description
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
Title
Number of patients that are able to return to their pre-injury living situation at 12 months
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilona Ahlborn
Phone
+41 61 328 71 97
Email
ilona.ahlborn@usb.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcel Jakob, Prof
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Basel
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4021
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilona Ahlborn
Phone
+41 61 328 71 97
Email
ilona.ahlborn@usb.ch
First Name & Middle Initial & Last Name & Degree
Hendrik Eckardt, Dr
12. IPD Sharing Statement
Citations:
PubMed Identifier
23871193
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.
Results Reference
background
Learn more about this trial
Treatment of Pelvic Ring Fractures in the Elderly
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