Femoral Neck FracturesPhase 2/3HUANCT01798472
Hip Fractures Treated With Uncemented Arthroplasties
A Phase 2/3 study testing cemented hemiarthroplasty, reverse hybrid total hip arthroplasty and cemented total hip arthroplasty in people with Femoral Neck Fractures, run by Stockholm South General Hospital at 1 site in Sweden.
Trial summary
The aim of this study is to compare the functional and radiological outcome after displaced, femoral neck fractures treated with either cemented or uncemented arthroplasties. The primary hypothesis is that the uncemented arthroplasty shows the same functional outcome at 12 month as the cemented arthroplasty. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- cemented hemiarthroplasty, reverse hybrid total hip arthroplasty and cemented total hip arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2009to Nov 2018
- Phase
- Phase 2/3
- 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
- displaced fracture of the femoral neck
- independent living
- independent ambulation (with or without walking aids)
Who cannot join
- pathological fracture
- severe dementia (defined as ≤3 in short portable mental questionnaire) preoperatively
- preexisting ipsilateral hip disease
- neurological disease (e.g. M. Parkinson)
- psychiatric disease which makes understanding or following instructions impossible
- history of drug and alcohol abuse
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Södersjukhuset (South general hospital), Department of orthopedic surgery
Stockholm, 118 83
Christian Inngul, M.D., 0046708355969, christian.inngul@sodersjukhuset.se
Christian Inngul, M.D.
About this study
Official title: Cemented Versus Uncemented Arthroplasty in Elderly Patients With Displaced Femoral Neck Fractures: a Randomized Controlled Trial
The aim of this study is to compare the functional and radiological outcome after displaced, femoral neck fractures treated with either cemented or uncemented arthroplasties.
The primary hypothesis is that the uncemented arthroplasty shows the same functional outcome at 12 month as the cemented arthroplasty.
Read the detailed description
Femoral neck fracture is a common cause of suffering and premature mortality among the elderly. Riskfactors for femoral neck fractures are age, gender, osteoporosis and cognitive dysfunction.
Mortality and morbidity varies between undisplaced and displaced femoral neck fractures.
Different treatment options are available: reduction and internal fixation vs joint replacement (arthroplasty). The treatment of undisplaced femoral neck fractures is uncontroversial and consists of internal fixation with screws.
The treatment of displaced, femoral neck fractures with internal fixation shows unacceptable results with complications rates leading to reoperation between 40-60%. Treatment of these fractures with arthroplasties has therefore become the standard treatment in industrial countries.
Fixation of the femoral component with bone-cement is standard procedure in Europe today. To avoid negative cardio-pulmonary events in patients with serious comorbidities and in very old and frail patients uncemented femoral components or internal fixation are used. These uncemented stems are mostly older design with poor track records. The use of modern, well-documented stems used in an osteoarthritis population for fracture patients has still to be tested.
- Conditions
- Femoral Neck Fractures
- Being tested
- cemented hemiarthroplasty, reverse hybrid total hip arthroplasty, cemented total hip arthroplasty, uncemented hemiarthroplasty
- Keywords
- displaced femoral neck fractures, treatment, uncemented arthroplasty, cemented arthroplasty
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cemented hemiarthroplastyProcedure or surgery
Also called Femoral stem, Exeter, Stryker, Unipolar femoral head, Stryker, Bone cement, Optipac, Biomet
Patients aged 80 years and older operated with an cemented hemiarthroplasty. Fixation of the wedge-shaped, polished ChromCobalt steel femoral stem to host bone by use of PolyMetylMetAcrylat bone cement. The acetabulum is not replaced. The prosthesis articulates with the patients acetabulum with an unipolar, femoral head made of ChromCobalt steel.
reverse hybrid total hip arthroplastyProcedure or surgery
Also called Femoral stem: Bimetric, Biomet, Acetabular cup, Maraton, DePuy, Bone cement, Optipac, Biomet
Patients aged 65 to 79 years operated with an uncemented femoral component combined with cemented acetabular cup. The femoral stem is fixed to the host bone by press-fit technique. We use a tapered, proximally hydroxyapatite coated, titanium stem. The acetabular cup is fixed to the host bone with bone cement. We use an all-polyethylene design. Bone cement consists of PolyMetylMetAcrylat.
cemented total hip arthroplastyProcedure or surgery
Also called Femoral stem: Exeter, Stryker, Acetabular cup, Marathon, DePuy, Bone cement, Optipac, Biomet
Patients aged 65 to 79 years operated with a cemented femoral stem combined with a cemented acetabular cup. Femoral and acetabular component are fixed to the host bone by use of bone cement. The femoral stem is a polished, wedge-shaped design made of ChromCobalt steel. The acetabular cup is fixed to the host bone with bone cement.The acetabular cup an all-polyethylene design. Bone cement consists of PolyMetAcrylat.
uncemented hemiarthroplastyProcedure or surgery
Also called Femoral stem: Bimetric, Biomet, Femoral head: Biomet
Patients aged 80 years and older are randomized to uncemented hemiarthroplasty. Fixation of the tapered, proximally hydroxyapatite coated, titanium stem to the host bone by "press-fit"-technique. The acetabulum is not replaced. The prosthesis articulates with the patients acetabulum with an unipolar, femoral head made of ChromCobalt steel.
| Study group | Role | What they receive |
|---|---|---|
| uncemented hemiarthroplasty | Experimental | Patients aged 80 or older with displaced femoral neck fracture treated with an uncemented hemiarthroplasty Receives: Procedure: uncemented hemiarthroplasty |
| reverse hybrid total hip arthroplasty | Experimental | Patients aged between 65 and 79 years treated with an reverse hybrid arthroplasty. Receives: Procedure: reverse hybrid total hip arthroplasty |
| cemented hemiarthroplasty | Active comparator | Patients aged 80 or older with displaced femoral neck fracture treated with an cemented hemiarthroplasty Receives: Procedure: cemented hemiarthroplasty |
| cemented total hip arthroplasty | Active comparator | Patients aged between 65 and 79 years treated with an cemented total hip arthroplasty. Receives: Procedure: cemented total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score
Our primary outcome variable is the Harris Hip Score at 12 month follow up. Harris Hip Score is an investigator reported tool evaluating hip function in four dimensions:
Pain, function, absence of deformity and range of motion
Measured: 12 month
Secondary outcomes (2)
Health related quality of life
We use the patient reported instrument EQ-5D. A questionnaire consisting of 5 questions to evaluate health related quality of life.
Measured: 12 month
Radiological follow up
Evaluation of radiological outcome on standard hip radiographies with focus on bony ingrowth, signs of loosening and subsidence
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startNov 2009
- Primary completionNov 2016 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FracturesStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stockholm South General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Christian Inngul, Stockholm South General Hospital
- Investigators
- Sari Ponzer, M.D. Prof, Study director, Department of orthopedic surgery, South general hospital, Sjukhusbacken 10, 118 83 Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798472
- Sponsor's protocol ID
- 2009/1188-31/1
- Acronym
- HUA
- Status last verified
- Jan 2015
- First submitted
- 19 Feb 2013
- Last updated
- 16 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cemented Versus Uncemented Arthroplasty in Elderly Patients With Displaced Femoral Neck Fractures: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01798472
- Acronym / sponsor ID
- HUA / 2009/1188-31/1
- Conditions
- Femoral Neck Fractures
- Keywords
- displaced femoral neck fractures, treatment, uncemented arthroplasty, cemented arthroplasty
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Stockholm South General HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Nov 2009
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 25 Feb 2013 (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.
The aim of this study is to compare the functional and radiological outcome after displaced, femoral neck fractures treated with either cemented or uncemented arthroplasties.
The primary hypothesis is that the uncemented arthroplasty shows the same functional outcome at 12 month as the cemented arthroplasty.
Detailed description
Femoral neck fracture is a common cause of suffering and premature mortality among the elderly. Riskfactors for femoral neck fractures are age, gender, osteoporosis and cognitive dysfunction.
Mortality and morbidity varies between undisplaced and displaced femoral neck fractures.
Different treatment options are available: reduction and internal fixation vs joint replacement (arthroplasty). The treatment of undisplaced femoral neck fractures is uncontroversial and consists of internal fixation with screws.
The treatment of displaced, femoral neck fractures with internal fixation shows unacceptable results with complications rates leading to reoperation between 40-60%. Treatment of these fractures with arthroplasties has therefore become the standard treatment in industrial countries.
Fixation of the femoral component with bone-cement is standard procedure in Europe today. To avoid negative cardio-pulmonary events in patients with serious comorbidities and in very old and frail patients uncemented femoral components or internal fixation are used. These uncemented stems are mostly older design with poor track records. The use of modern, well-documented stems used in an osteoarthritis population for fracture patients has still to be tested.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| uncemented hemiarthroplasty | Experimental | Procedure: uncemented hemiarthroplastyPatients aged 80 or older with displaced femoral neck fracture treated with an uncemented hemiarthroplasty |
| reverse hybrid total hip arthroplasty | Experimental | Procedure: reverse hybrid total hip arthroplastyPatients aged between 65 and 79 years treated with an reverse hybrid arthroplasty. |
| cemented hemiarthroplasty | Active comparator | Procedure: cemented hemiarthroplastyPatients aged 80 or older with displaced femoral neck fracture treated with an cemented hemiarthroplasty |
| cemented total hip arthroplasty | Active comparator | Procedure: cemented total hip arthroplastyPatients aged between 65 and 79 years treated with an cemented total hip arthroplasty. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- displaced fracture of the femoral neck
- independent living
- independent ambulation (with or without walking aids)
Key exclusion criteria (6 listed)
- pathological fracture
- severe dementia (defined as ≤3 in short portable mental questionnaire) preoperatively
- preexisting ipsilateral hip disease
- neurological disease (e.g. M. Parkinson)
- psychiatric disease which makes understanding or following instructions impossible
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 |
|---|---|---|
| cemented hemiarthroplastyAlso: Femoral stem, Exeter, Stryker, Unipolar femoral head, Stryker, Bone cement, Optipac, BiometPatients aged 80 years and older operated with an cemented hemiarthroplasty. Fixation of the wedge-shaped, polished ChromCobalt steel femoral stem to host bone by use of PolyMetylMetAcrylat bone cement. The acetabulum is not replaced. The prosthesis articulates with the patients acetabulum with an unipolar, femoral head made of ChromCobalt steel. | Procedure or surgery | cemented hemiarthroplasty |
| reverse hybrid total hip arthroplastyAlso: Femoral stem: Bimetric, Biomet, Acetabular cup, Maraton, DePuy, Bone cement, Optipac, BiometPatients aged 65 to 79 years operated with an uncemented femoral component combined with cemented acetabular cup. The femoral stem is fixed to the host bone by press-fit technique. We use a tapered, proximally hydroxyapatite coated, titanium stem. The acetabular cup is fixed to the host bone with bone cement. We use an all-polyethylene design. Bone cement consists of PolyMetylMetAcrylat. | Procedure or surgery | reverse hybrid total hip arthroplasty |
| cemented total hip arthroplastyAlso: Femoral stem: Exeter, Stryker, Acetabular cup, Marathon, DePuy, Bone cement, Optipac, BiometPatients aged 65 to 79 years operated with a cemented femoral stem combined with a cemented acetabular cup. Femoral and acetabular component are fixed to the host bone by use of bone cement. The femoral stem is a polished, wedge-shaped design made of ChromCobalt steel. The acetabular cup is fixed to the host bone with bone cement.The acetabular cup an all-polyethylene design. Bone cement consists of PolyMetAcrylat. | Procedure or surgery | cemented total hip arthroplasty |
| uncemented hemiarthroplastyAlso: Femoral stem: Bimetric, Biomet, Femoral head: BiometPatients aged 80 years and older are randomized to uncemented hemiarthroplasty. Fixation of the tapered, proximally hydroxyapatite coated, titanium stem to the host bone by "press-fit"-technique. The acetabulum is not replaced. The prosthesis articulates with the patients acetabulum with an unipolar, femoral head made of ChromCobalt steel. | Procedure or surgery | uncemented hemiarthroplasty |
Primary outcome
Harris Hip Score
Time frame: 12 month
Our primary outcome variable is the Harris Hip Score at 12 month follow up. Harris Hip Score is an investigator reported tool evaluating hip function in four dimensions: Pain, function, absence of deformity and range of motion
2 secondary outcomes
Health related quality of life
Time frame: 12 month
Radiological follow up
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
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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.
Sari Ponzer, M.D. Prof study director
Department of orthopedic surgery, South general hospital, Sjukhusbacken 10, 118 83 Stockholm, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing cemented hemiarthroplasty, reverse hybrid total hip arthroplasty and cemented total hip arthroplasty in people with Femoral Neck Fractures, run by Stockholm South General Hospital at 1 site in Sweden.
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 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: status not confirmed, as of the sponsor's last update on 16 Jan 2015. 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 Sweden. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Inngul, MD (0046708355969, christian.inngul@sodersjukhuset.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harris Hip Score (time frame: 12 month). 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 16 Jan 2015.