Femoral Neck FracturesHOPENCT02246335
Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly
A study testing Cemented total hip arthroplasty and Cemented hemiarthroplasty in people with Femoral Neck Fractures, run by Danderyd Hospital at 1 site in Sweden.
Trial summary
Total Hip Arthroplasty is equal to or better than Hemiarthroplasty in the treatment of displaced femoral neck fractures in the elderly-elderly Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- Cemented total hip arthroplasty and Cemented hemiarthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2009to Oct 2020
- 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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Acute displaced femoral neck fracture of hip (Garden classification 3-4)
- Independent walker with or without walking aides
- Patient willing to participate in the study and give written consent.
Who cannot join
- Fracture older than 36 hours before admission
- Osteoarthritis in the fractured hip
- Rheumatoid arthritis in the fractured hip
- Pathological fractures
- Contraindication for hip arthroplasty surgery
- Not suitable for inclusion for other reasons e.g. substance abuse
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Orthopaedic department, Danderyd Hospital
Stockholm, Stockholm County, 18288
About this study
Official title: Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly. A Randomized Controlled Trial.
Total Hip Arthroplasty is equal to or better than Hemiarthroplasty in the treatment of displaced femoral neck fractures in the elderly-elderly
Read the detailed description
Total Hip Arthroplasty is equal to or better alternative to Hemiarthroplasty in the treatment of displaced femoral neck fractures in the elderly-elderly (patients 80 years and over).
- Conditions
- Femoral Neck Fractures
- Being tested
- Cemented total hip arthroplasty, Cemented hemiarthroplasty
- 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 total hip arthroplastyDevice
Cemented hemiarthroplastyDevice
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Hemiarthroplasty Receives: Device: Cemented hemiarthroplasty |
| Treatment group | Active comparator | Total hip arthroplasty Receives: Device: Cemented total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris hip score
The hip specific outcome score Harris hip score at 2 years will be the main outcome variable
Measured: 2 years
Secondary outcomes (11)
EQ-5D
Health-related quality of life at 2 years
Measured: 2 years
EQ-5D
Health-related quality of life at 4 years
Measured: 4 years
EQ-5D
Health-related quality of life at 6 years
Measured: 6 years
EQ-5D
Health-related quality of life at 10 years
Measured: 10 years
Adverse events
All hip related adverse events at 2 years
Measured: 2 years
Adverse events
All hip related adverse events at 4 years
Measured: 4 years
Adverse events
All hip related adverse events at 6 years
Measured: 6 years
Adverse events
All hip related adverse events at 10 years
Measured: 10 years
Harris hip score
Harris hip score at 4 years
Measured: 4 years
Harris hip score
Harris hip score at 6 years
Measured: 6 years
Harris hip score
Harris hip score at 10 years
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study startOct 2009
- Primary completionOct 2016 (estimated)
- Study completionOct 2020 (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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olof Skoldenberg, Danderyd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246335
- Sponsor's protocol ID
- HOPE
- Acronym
- HOPE
- Status last verified
- Aug 2016
- First submitted
- 18 Sep 2014
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Skoldenberg O, Chammout G, Mukka S, Muren O, Nasell H, Hedbeck CJ, Salemyr M. HOPE-trial: hemiarthroplasty compared to total hip arthroplasty for displaced femoral neck fractures in the elderly-elderly, a randomized controlled trial. BMC Musculoskelet Disord. 2015 Oct 19;16:307. doi: 10.1186/s12891-015-0763-3.
PubMed 26480938
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02246335
- Acronym / sponsor ID
- HOPE / HOPE
- Conditions
- Femoral Neck Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 22 Sep 2014 (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.
Total Hip Arthroplasty is equal to or better than Hemiarthroplasty in the treatment of displaced femoral neck fractures in the elderly-elderly
Detailed description
Total Hip Arthroplasty is equal to or better alternative to Hemiarthroplasty in the treatment of displaced femoral neck fractures in the elderly-elderly (patients 80 years and over).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: Cemented hemiarthroplastyHemiarthroplasty |
| Treatment group | Active comparator | Device: Cemented total hip arthroplastyTotal hip arthroplasty |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Acute displaced femoral neck fracture of hip (Garden classification 3-4)
- Independent walker with or without walking aides
- Patient willing to participate in the study and give written consent.
Key exclusion criteria (6 listed)
- Fracture older than 36 hours before admission
- Osteoarthritis in the fractured hip
- Rheumatoid arthritis in the fractured hip
- Pathological fractures
- Contraindication for hip arthroplasty surgery
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 total hip arthroplasty | Device | Treatment group |
| Cemented hemiarthroplasty | Device | Control group |
Primary outcome
Harris hip score
Time frame: 2 years
The hip specific outcome score Harris hip score at 2 years will be the main outcome variable
11 secondary outcomes
EQ-5D
Time frame: 2 years
EQ-5D
Time frame: 4 years
EQ-5D
Time frame: 6 years
EQ-5D
Time frame: 10 years
Adverse events
Time frame: 2 years
Adverse events
Time frame: 4 years
Adverse events
Time frame: 6 years
Adverse events
Time frame: 10 years
Harris hip score
Time frame: 4 years
Harris hip score
Time frame: 6 years
Harris hip score
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Derived from this study: PubMed 26480938Skoldenberg O, Chammout G, Mukka S, Muren O, Nasell H, Hedbeck CJ, Salemyr M. HOPE-trial: hemiarthroplasty compared to total hip arthroplasty for displaced femoral neck fractures in the elderly-elderly, a randomized controlled trial. BMC Musculoskelet Disord. 2015 Oct 19;16:307. doi: 10.1186/s12891-015-0763-3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cemented total hip arthroplasty and Cemented hemiarthroplasty in people with Femoral Neck Fractures, run by Danderyd 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 30 Aug 2016. 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.
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?
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?
Harris hip score (time frame: 2 years). 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 NCT02246335, 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 30 Aug 2016.