Pelvic Bone InjuryPELVICNCT06054165
Impact of a Clinical Pathway for Pelvic Fragility Fractures
A study testing Clinical pathway in people with Pelvic Bone Injury and Sacral Fracture, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 8 sites in Netherlands.
Trial summary
Patients with pelvic fragility fractures suffer from high morbidity and mortality rates. Despite the high incidence of these injuries, there is currently no regional or nationwide treatment protocol which results in a wide variety of clinical practice. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Pelvic Bone Injury, Sacral Fracture, Pelvic Fracture
- What is being tested?
- Clinical pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 393 participants
- Where
- 8 sitesNetherlands
- Study dates
- 21 Jan 2024to 27 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pelvic fragility fracture caused by low energetic trauma
- Patients presented at the emergency room or out-patient clinic of a participating hospital
Who cannot join
- Patients with high suspicion of a pelvic fracture due to a malignant tumor
- Patients who are unable to follow instructions due to severe cognitive decline (for example due to dementia or Alzheimer's disease)
- Patients who pre-trauma received palliative or terminal care
- Patients who pre-trauma were wheelchair bound or bedridden
- Patients who suffer from complications from previous pelvic ring fixation
- Patients with insufficient comprehension of the Dutch language to be able to carry out the physiotherapy instructions for early mobilization
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Netherlands8 sites, 8 recruiting
- Recruiting
Noordwest Ziekenhuisgroep
Alkmaar, North Holland, 1815 JD
Kees-Jan Ponsen
- Recruiting
Flevoziekenhuis
Almere Stad, Flevoland, 1315 RA
Anne Ottenhof
- Recruiting
BovenIJ ziekenhuis
Amsterdam, North Holland, 1034 CS
Bas Twigt
- Recruiting
OLVG
Amsterdam, North Holland, 1061 AE
Carel Goslings
- Recruiting
Amsterdam UMC
Amsterdam, North Holland, 1105 AZ
Daphne van Embden
- Recruiting
Spaarne Gasthuis
Haarlem, North Holland, 2035 RC
Max Meeuwis
- Recruiting
Dijklander Ziekenhuis
Hoorn, North Holland, 1624 NP
Jasper Winkelhagen
- Recruiting
Zaans Medisch Centrum
Zaandam, North Holland, 1502 DV
Robert Jan Derksen
About this study
Official title: Impact of Regional Implementation of a Clinical Pathway for ELderly Patients With pelVIc Fragility fraCtures (PELVIC); a Multicenter, Stepped-wedge Randomized Controlled Trial
Patients with pelvic fragility fractures suffer from high morbidity and mortality rates. Despite the high incidence of these injuries, there is currently no regional or nationwide treatment protocol which results in a wide variety of clinical practice. New insights in treatment strategies, such as early diagnosis and minimal invasive operative treatment of these fragile patient population, has led to the development of several clinical pathways in recent literature. The aim of this study is to implement an evidence and experience-based treatment clinical pathway to improve the outcomes in this fragile patient population that currently has multifactorial risks for poor outcome.
- Being tested
- Clinical pathway
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical pathwayOther
Evidence-based and expert-opinion-based clinical pathway regarding the diagnostic and treatment strategy
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-care | No intervention | Not described |
| Best-practice | Active comparator | Not described Receives: Other: Clinical pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility, using the Parker mobility score (PMS)
Since there is no validated tool to measure mobility specifically after a pelvic fracture, the investigators choose to use The Parker mobility score as a primary outcome measurement. The Parker mobility score is a valid and reliable score measuring mobility in hip fracture patients. The Parker Mobility Score answers three questions, each valued 0-3 points, and is commonly used in clinical practice to monitor the mobility of geriatric patients. A score of 0-3 is considered low, 4-6 moderate, and 7-9 reflects good mobility. Furthermore, the Parker Mobility Score is a validated assessment tool for mortality in patients with reduced mobility after hip surgery.
Measured: Change from baseline PMS at 2 weeks, 3 months, 6 months, and 1 year
Secondary outcomes (10)
Mobility, using the Elderly mobility scale (EMS)
The Elderly Mobility Scale is a 20 point validated assessment tool to evaluate mobility specifically in elderly patients. The investigators decided, despite the fact that this tool has an element of measurement in it which makes it harder to determine the pre-injury score, to add this tool since it does a better job distinguishing between patients who are able to sit up and go from sitting to standing. The Elderly mobility scale ranges from 0-20 points, with high scores representing better outcome than low scores.
Measured: At 2 weeks, 3 months, and 1 year
Functional performance, using the Katz Index of Independence in Activities of Daily Living (KATZ ADL)
This index is one of the most commonly used scores to measure the functional status of elderly individuals. It assesses the activities of daily living using six questions, each valued 0 or 1. The score ranges from 0-6, and a score of 6 indicates full function while 4 indicates moderate impairment, and 2 or less indicates severe functional impairment
Measured: Change from baseline KATZ ADL at 3 months and 1 year
Quality of life, using the EuroQol (EQ-5D-5L) score
The EQ-5D-5L is a generic quality of life questionnaire which consists of a visual analogue scale and five questions about mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each question has three answer alternatives, with 1 indicating the optimal health state and 5 indicating severe problems. There are 3,125 possible health states defined by combining one level from each dimension, ranging from 11111 (full health) to 55555 (worst health).
Measured: Change from baseline EQ-5D-5L at 1 year
Return to home rate
The residencies will be grouped in 'living independently at home', 'assisted living', 'nursing home', 'rehabilitation centre', 'palliative care facility'.
Measured: Change from baseline place of residency at 6 weeks, 3 months, 6 months and 1 year
Level of pain, using the Numerical Pain Rating Scale (NRS)
The Numerical Pain Rating Scale is an aspecific measurement tool from 0-10, with 0 reflecting no pain, 1-4 mild pain, 5-7 moderate pain, and 7-10 severe pain. This tool is currently already used by nurses in all hospitals in the Netherlands.
Measured: Baseline, one day post-operative (if patient underwent surgery), at 2 weeks, 6 weeks, 3 months and 1 year
Descriptive name and dosage of analgesic medications used
All analgesic medication that the patient is given will be recorded, and compared to the analgesic medication that the patient used prior to injury. The medication will be categorized according to the World Health Organisation analgesic ladder to facilitate comparison of changes in patients' analgesic medication usage.
Measured: Baseline, 2 weeks, 6 weeks, 3 months, and 1 year
Number of falls after treatment, resulting in additional injury or without injury
The investigators will differentiate between 'serious falls', defined as falls where the patient gets injured, and 'minor falls' where the patient did not get injured. The investigators will ask the patients during follow-up at the out-patient clinic if they fell since the last visit. The frequency of falling is related to an increased risk of mortality in elderly patients.
Measured: At 6 weeks and 3 months
Number of participants with (fracture related) complications
This includes general complications tot may occur during a period of reduced mobility or hospital admission (such as pneumonia, urinary tract infection, thromboembolic event, heart failure, cerebrovascular event, myocardial infarction). Complications related to operative treatment will also be recorded. These complications include but are not limited to: re-operation, delayed operation, infection, screw back out, malposition of screw, neurological damage. All complications will be categorized for level of severity and the necessity for further treatment according to the Clavien-Dindo classification
Measured: At 2 weeks, 3 months, 6 months, and 1 year
1-year mortality
Including (presumed) cause of death
Measured: At 1 year
2-year mortality
Including (presumed) cause of death
Measured: At 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start21 Jan 2024
- Primary completion27 Apr 2025 (estimated)
- Study completion27 Apr 2027 (estimated)
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 Bone InjuryStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped-wedge cluster randomized trial
- Masking
- None (open label)
- Enrolment
- 393 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Noordwest Ziekenhuisgroep
- Responsible party
- Principal investigator, Dr. Daphne van Embden, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Frank W Bloemers, prof, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054165
- Sponsor's protocol ID
- W22_279
- Acronym
- PELVIC
- Status last verified
- Jun 2024
- First submitted
- 21 Mar 2023
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Publications
Mennen AHM, Lommerse M, Hemke R, Willems HC, Maas M, Bloemers FW, Ponsen KJ, Van Embden D. Does regional implementation of a clinical pathway for older adult patients with pelvic fragility fractures after low-energy trauma improve patient outcomes (PELVIC): a multicentre, stepped-wedge, randomised controlled trial. BMJ Open. 2024 Aug 13;14(8):e083809. doi: 10.1136/bmjopen-2023-083809.
PubMed 39142675
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Regional Implementation of a Clinical Pathway for ELderly Patients With pelVIc Fragility fraCtures (PELVIC); a Multicenter, Stepped-wedge Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06054165
- Acronym / sponsor ID
- PELVIC / W22_279
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 393 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Noordwest Ziekenhuisgroep
- Study start
- 21 Jan 2024 (actual)
- Primary completion
- 27 Apr 2025 (estimated)
- Study completion
- 27 Apr 2027 (estimated)
- First posted
- 26 Sep 2023 (actual)
- 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.
Patients with pelvic fragility fractures suffer from high morbidity and mortality rates. Despite the high incidence of these injuries, there is currently no regional or nationwide treatment protocol which results in a wide variety of clinical practice. New insights in treatment strategies, such as early diagnosis and minimal invasive operative treatment of these fragile patient population, has led to the development of several clinical pathways in recent literature. The aim of this study is to implement an evidence and experience-based treatment clinical pathway to improve the outcomes in this fragile patient population that currently has multifactorial risks for poor outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Standard-of-care | No intervention | – |
| Best-practice | Active comparator | Other: Clinical pathway |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pelvic fragility fracture caused by low energetic trauma
- Patients presented at the emergency room or out-patient clinic of a participating hospital
Key exclusion criteria (6 listed)
- Patients with high suspicion of a pelvic fracture due to a malignant tumor
- Patients who are unable to follow instructions due to severe cognitive decline (for example due to dementia or Alzheimer's disease)
- Patients who pre-trauma received palliative or terminal care
- Patients who pre-trauma were wheelchair bound or bedridden
- Patients who suffer from complications from previous pelvic ring fixation
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 |
|---|---|---|
| Clinical pathwayEvidence-based and expert-opinion-based clinical pathway regarding the diagnostic and treatment strategy | Other | Best-practice |
Primary outcome
Mobility, using the Parker mobility score (PMS)
Time frame: Change from baseline PMS at 2 weeks, 3 months, 6 months, and 1 year
Since there is no validated tool to measure mobility specifically after a pelvic fracture, the investigators choose to use The Parker mobility score as a primary outcome measurement. The Parker mobility score is a valid and reliable score measuring mobility in hip fracture patients. The Parker Mobility Score answers three questions, each valued 0-3 points, and is commonly used in clinical practice to monitor the mobility of geriatric patients. A score of 0-3 is considered low, 4-6 moderate, and 7-9 reflects good mobility. Furthermore, the Parker Mobility Score is a validated assessment tool for mortality in patients with reduced mobility after hip surgery.
10 secondary outcomes
Mobility, using the Elderly mobility scale (EMS)
Time frame: At 2 weeks, 3 months, and 1 year
Functional performance, using the Katz Index of Independence in Activities of Daily Living (KATZ ADL)
Time frame: Change from baseline KATZ ADL at 3 months and 1 year
Quality of life, using the EuroQol (EQ-5D-5L) score
Time frame: Change from baseline EQ-5D-5L at 1 year
Return to home rate
Time frame: Change from baseline place of residency at 6 weeks, 3 months, 6 months and 1 year
Level of pain, using the Numerical Pain Rating Scale (NRS)
Time frame: Baseline, one day post-operative (if patient underwent surgery), at 2 weeks, 6 weeks, 3 months and 1 year
Descriptive name and dosage of analgesic medications used
Time frame: Baseline, 2 weeks, 6 weeks, 3 months, and 1 year
Number of falls after treatment, resulting in additional injury or without injury
Time frame: At 6 weeks and 3 months
Number of participants with (fracture related) complications
Time frame: At 2 weeks, 3 months, 6 months, and 1 year
1-year mortality
Time frame: At 1 year
2-year mortality
Time frame: At 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Derived from this study: PubMed 39142675Mennen AHM, Lommerse M, Hemke R, Willems HC, Maas M, Bloemers FW, Ponsen KJ, Van Embden D. Does regional implementation of a clinical pathway for older adult patients with pelvic fragility fractures after low-energy trauma improve patient outcomes (PELVIC): a multicentre, stepped-wedge, randomised controlled trial. BMJ Open. 2024 Aug 13;14(8):e083809. doi: 10.1136/bmjopen-2023-083809.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
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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.
Frank W Bloemers, prof principal investigator
Amsterdam UMC
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical pathway in people with Pelvic Bone Injury and Sacral Fracture, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 8 sites in Netherlands.
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daphne van Embden, MD, PhD (020-566 9111, d.vanembden@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobility, using the Parker mobility score (PMS) (time frame: Change from baseline PMS at 2 weeks, 3 months, 6 months, and 1 year). 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 NCT06054165, 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 24 Jun 2024.