Pelvic PainNCT02590783
Treatment of Pelvic Ring Fractures in the Elderly
A study testing experimental intervention surgery in people with Pelvic Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pelvic Pain
- What is being tested?
- experimental intervention surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Oct 2017to 11 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4021
About this study
Official title: 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.
Read the detailed description
Comparison of surgical vs conservative treatment with respect to mobility, pain, morbidity and mortality.
- Conditions
- Pelvic Pain
- Being tested
- experimental intervention surgery, control intervention
- Keywords
- treatment
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental intervention surgeryProcedure or 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).
control interventionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental intervention surgery | Experimental | 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 Receives: Procedure: experimental intervention surgery |
| control intervention conservative | Active comparator | analgesia, physiotherapy, work-up for osteoporosis, geriatric rehabilitation if necessary Receives: Procedure: control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks post-diagnosis
Secondary outcomes (11)
Activities of Daily Living (ADL) at baseline
Functional recovery will be measured using the ADL score.
Measured: baseline
Activities of Daily Living (ADL) at 4-7 days after diagnosis
Functional recovery will be measured using the ADL score.
Measured: 4-7 days after diagnosis
Activities of Daily Living (ADL) at 3 weeks
Functional recovery will be measured using the ADL score.
Measured: 3 weeks
Activities of Daily Living (ADL) at 3 months
Functional recovery will be measured using the ADL score.
Measured: 3 months
Activities of Daily Living (ADL) at 12 months
Functional recovery will be measured using the ADL score.
Measured: 12 months
Pain (VAS 10) at baseline
Pain will be assessed using the 10 point Visual Analogue Scale (VAS10).
Measured: baseline
Pain (VAS 10) at 4-7 days after diagnosis
Pain will be assessed using the 10 point Visual Analogue Scale (VAS10).
Measured: 4-7 days after diagnosis
Pain (VAS 10) at 3 weeks
Pain will be assessed using the 10 point Visual Analogue Scale (VAS10).
Measured: 3 weeks
Pain (VAS 10) at 3 months
Pain will be assessed using the 10 point Visual Analogue Scale (VAS10).
Measured: 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".
Measured: 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".
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study start17 Oct 2017
- Primary completion11 Jul 2022
- Study completion11 Jul 2022
Why it stopped: study question was not suitable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcel Jakob, Prof, Study director, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590783
- Sponsor's protocol ID
- 2015-188
- Status last verified
- May 2024
- First submitted
- 22 Sep 2015
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 23871193
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Pelvic Ring Fractures in the Elderly: A Randomized Controlled Trial Comparing Surgical vs. Conservative Therapy
- ClinicalTrials.gov ID
- NCT02590783
- Acronym / sponsor ID
- 2015-188
- Conditions
- Pelvic Pain
- Keywords
- treatment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study question was not suitable
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 11 Jul 2022 (actual)
- Study completion
- 11 Jul 2022 (actual)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental intervention surgery | Experimental | Procedure: experimental intervention surgeryscrew 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 | Active comparator | Procedure: control interventionanalgesia, physiotherapy, work-up for osteoporosis, geriatric rehabilitation if necessary |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| experimental intervention surgeryPatients 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). | Procedure or surgery | experimental intervention surgery |
| control interventionMobilization 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. | Procedure or surgery | control intervention conservative |
Primary outcome
Mobility at 3 weeks post-diagnosis
Time frame: 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.
11 secondary outcomes
Activities of Daily Living (ADL) at baseline
Time frame: baseline
Activities of Daily Living (ADL) at 4-7 days after diagnosis
Time frame: 4-7 days after diagnosis
Activities of Daily Living (ADL) at 3 weeks
Time frame: 3 weeks
Activities of Daily Living (ADL) at 3 months
Time frame: 3 months
Activities of Daily Living (ADL) at 12 months
Time frame: 12 months
Pain (VAS 10) at baseline
Time frame: baseline
Pain (VAS 10) at 4-7 days after diagnosis
Time frame: 4-7 days after diagnosis
Pain (VAS 10) at 3 weeks
Time frame: 3 weeks
Pain (VAS 10) at 3 months
Time frame: 3 months
Number of patients that are able to return to their pre-injury living situation at 3 months
Time frame: 3 months
Number of patients that are able to return to their pre-injury living situation at 12 months
Time frame: 12 months
Results and safety
The study was stopped early (reason given: study question was not suitable). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Background: PubMed 23871193Rommens 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcel Jakob, Prof study director
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental intervention surgery in people with Pelvic Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: study question was not suitable). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobility at 3 weeks post-diagnosis (time frame: 3 weeks post-diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02590783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.