Acetabular FractureNCT04724811
Weight-bearing of Surgically Treated Acetabular Fractures.
A study testing Open reduction and internal fixation (ORIF) in people with Acetabular Fracture, run by Hospital District of Helsinki and Uusimaa at 1 site in Finland.
Trial summary
The purpose of this study is to determine whether patients with operatively treated acetabular fractures benefit from early weight-bearing as tolerated. The study compares two groups ( n = 25 each), which are randomised into either weight-bearing as tolerated or touch-down weight-bearing for 6-8 weeks postoperatively. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acetabular Fracture
- What is being tested?
- Open reduction and internal fixation (ORIF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFinland
- Study dates
- May 2024to Dec 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Unilateral dislocated acetabulum fracture (displacement of over 2mm in preoperative CT scan)
- The osteosynthesis is performed during 21 days after initial trauma
- The patient is willing to participate in the follow-up
Who cannot join
- Unwillingness to participate in randomisation
- Bilateral fracture
- Letournel \& Judet type Both column or Posterior column and wall fractures
- Any other injury that prevents the patient from partial weight bearing
- Open fracture of the acetabulum
- Pathologic fracture (fragility fractures are not an exclusion criteria)
Show all 12Show fewer
- Prior functional disability in the pelvis or lower extremity
- Non-Compliance due to dementia or other mental disability
- Prior daily pain medication due to hip-pain
- Unwillingness to accept one of the two mobilisation protocols
- Prior hip replacement on injured side
- BMI > 40
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Weight-bearing of Surgically Treated Acetabular Fractures. A Randomised Controlled Trial
The purpose of this study is to determine whether patients with operatively treated acetabular fractures benefit from early weight-bearing as tolerated. The study compares two groups ( n = 25 each), which are randomised into either weight-bearing as tolerated or touch-down weight-bearing for 6-8 weeks postoperatively.
Both study groups are stratified according to
Read more
- Type of fracture (anterior approach vs anterior + additional posterior approach)
- Dislocated dome vs non-dislocated/ non existing separate dome fragment
Patients, who are eligible to participate in the trial but choose not to participate in randomisation are asked to enrol in a prospective cohort follow-up cohort. This is to examine a potential participation bias in the RCT groups. These patients will not be counted into the target amount of 50 RCT patients.
Read the detailed description
For the past 20 years, the established treatment of dislocated acetabular fractures has been surgical reduction and stable osteosynthesis. Good long-term results have been reported in these patients. At present, the mobilisation of these patients after surgery is generally restricted for several weeks ranging from 6-12 weeks touch-down- or non-weight-bearing with no uniform protocol. However there is no scientific evidence for limiting post operative weight-bearing. Accordingly the need of studies on weight-bearing surrounding periarticular fractures has been advocated.
Acetabular fractures in the elderly population are becoming more common and pose significant challenges for treatment including postoperative rehabilitation. Our aim is to investigate if patients benefit of a more liberal weight-bearing regime postoperatively. The primary outcome is measured at 1 year, secondary outcomes are followed up to 10 years postoperatively
- Conditions
- Acetabular Fracture
- Being tested
- Open reduction and internal fixation (ORIF)
- Keywords
- Acetabulum, Periarticular fracture, Weight-bearing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open reduction and internal fixation (ORIF)Procedure or surgery
Approaches used:
- Intrapelvic approach +/- iliac window
- Kocher-Langenbeck approach
| Study group | Role | What they receive |
|---|---|---|
| Weight-bearing as tolerated | Experimental | Patients are instructed to mobilise the hip and weight-bear as tolerated Receives: Procedure: Open reduction and internal fixation (ORIF) |
| Touch-down weight-bearing | Active comparator | Patients are instructed to mobilise the hip. Touch-down weight-bearing for 6-8 weeks Receives: Procedure: Open reduction and internal fixation (ORIF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
mHHS
Modified Harris Hip Score, Scale 0-100, higher scores mean better outcome
Measured: 1 year
NRS
Pain during gate, Numerical Rating Scale, Scale 0-10 0=no pain, 10=worst pain
Measured: 1 year
Secondary outcomes (4)
mHHS
Modified Harris Hip Score, Scale 0-100, higher scores mean better outcome
Measured: 0 weeks, 6 weeks, 12 weeks, 6 months, 2 years, 5 years, 10 years
NRS
Pain at rest and during gate (2 scores), Numerical Rating Scale, Scale 0-10 0=no pain, 10=worst pain
Measured: 0 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years, 10 years
WOMAC
Western Ontario and McMaster Universities Osteoarthritis Index, Scale 0-96, higher scores mean better outcome
Measured: 0 weeks, 1 year, 2 years, 5 years, 10 years
RAND36
Patient reported quality of life, Scale 0-100, higher scores mean better outcome
Measured: 0 weeks, 1 Year, 2 years, 5 years, 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study startMay 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acetabular FractureStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- Prospective randomised non-inferiority study
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital District of Helsinki and Uusimaa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristian Seppänen, Hospital District of Helsinki and Uusimaa
- Investigators
- Jan Lindahl, MD, PhD, Study chair, Helsinki University Central HospitalKristian Seppänen, MD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724811
- Sponsor's protocol ID
- HUS/234/2020
- Status last verified
- Mar 2024
- First submitted
- 22 Jan 2021
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight-bearing of Surgically Treated Acetabular Fractures. A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04724811
- Acronym / sponsor ID
- HUS/234/2020
- Conditions
- Acetabular Fracture
- Keywords
- Acetabulum, Periarticular fracture, Weight-bearing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital District of Helsinki and UusimaaUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Jan 2021 (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.
The purpose of this study is to determine whether patients with operatively treated acetabular fractures benefit from early weight-bearing as tolerated. The study compares two groups ( n = 25 each), which are randomised into either weight-bearing as tolerated or touch-down weight-bearing for 6-8 weeks postoperatively.
Both study groups are stratified according to
- Type of fracture (anterior approach vs anterior + additional posterior approach)
- Dislocated dome vs non-dislocated/ non existing separate dome fragment
Patients, who are eligible to participate in the trial but choose not to participate in randomisation are asked to enrol in a prospective cohort follow-up cohort. This is to examine a potential participation bias in the RCT groups. These patients will not be counted into the target amount of 50 RCT patients.
Detailed description
For the past 20 years, the established treatment of dislocated acetabular fractures has been surgical reduction and stable osteosynthesis. Good long-term results have been reported in these patients. At present, the mobilisation of these patients after surgery is generally restricted for several weeks ranging from 6-12 weeks touch-down- or non-weight-bearing with no uniform protocol. However there is no scientific evidence for limiting post operative weight-bearing. Accordingly the need of studies on weight-bearing surrounding periarticular fractures has been advocated.
Acetabular fractures in the elderly population are becoming more common and pose significant challenges for treatment including postoperative rehabilitation. Our aim is to investigate if patients benefit of a more liberal weight-bearing regime postoperatively. The primary outcome is measured at 1 year, secondary outcomes are followed up to 10 years postoperatively
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Prospective randomised non-inferiority study
| Arm | Type | Receives |
|---|---|---|
| Weight-bearing as tolerated | Experimental | Procedure: Open reduction and internal fixation (ORIF)Patients are instructed to mobilise the hip and weight-bear as tolerated |
| Touch-down weight-bearing | Active comparator | Procedure: Open reduction and internal fixation (ORIF)Patients are instructed to mobilise the hip. Touch-down weight-bearing for 6-8 weeks |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unilateral dislocated acetabulum fracture (displacement of over 2mm in preoperative CT scan)
- The osteosynthesis is performed during 21 days after initial trauma
- The patient is willing to participate in the follow-up
Key exclusion criteria (12 listed)
- Unwillingness to participate in randomisation
- Bilateral fracture
- Letournel \& Judet type Both column or Posterior column and wall fractures
- Any other injury that prevents the patient from partial weight bearing
- Open fracture of the acetabulum
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 |
|---|---|---|
| Open reduction and internal fixation (ORIF)Approaches used: * Intrapelvic approach +/- iliac window * Kocher-Langenbeck approach | Procedure or surgery | Touch-down weight-bearing, Weight-bearing as tolerated |
Primary outcome
mHHS
Time frame: 1 year
Modified Harris Hip Score, Scale 0-100, higher scores mean better outcome
NRS
Time frame: 1 year
Pain during gate, Numerical Rating Scale, Scale 0-10 0=no pain, 10=worst pain
4 secondary outcomes
mHHS
Time frame: 0 weeks, 6 weeks, 12 weeks, 6 months, 2 years, 5 years, 10 years
NRS
Time frame: 0 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years, 10 years
WOMAC
Time frame: 0 weeks, 1 year, 2 years, 5 years, 10 years
RAND36
Time frame: 0 weeks, 1 Year, 2 years, 5 years, 10 years
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 6 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Jan Lindahl, MD, PhD study chair
Helsinki University Central Hospital
Kristian Seppänen, MD principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open reduction and internal fixation (ORIF) in people with Acetabular Fracture, run by Hospital District of Helsinki and Uusimaa at 1 site in Finland.
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 3 inclusion and 12 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: opening soon, as of the sponsor's last update on 6 Mar 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 Finland. 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 Kristian Seppänen, MD (094711, kristian.seppanen@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mHHS (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.