Femoral Neck FracturesPhase 1NCT01109862
Prospective Randomized Comparison of Bipolar Hemiarthroplasty and Total Hip Arthroplasty With Large Femoral Heads for the Treatment of Displaced Intracapsular Femoral Neck Fractures in the Elderly
A Phase 1 study testing Total hip arthroplasty and Hemiarthroplasty in people with Femoral Neck Fractures, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to compare hemiarthroplasty (HAP) with total hip arthroplasty (THA), performed by trained arthroplasty surgeons with the use of large femoral heads for the treatment of displaced femoral neck fractures in mobile independent elderly patients, to determine the impact of these surgical… Read more about this study
- Who is it for?
- Ages 70 to 90 years
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- Total hip arthroplasty and Hemiarthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2010to Dec 2013
- Phase
- Phase 1
- 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 70 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 1. Acute femoral neck fracture.
- 2. Age between 70 and 90 years old.
- 3. Independent community ambulator (more than 0.5km, without the aid of another person. The use of a cane is permitted) prior to fracture.
- 4. Abbreviated mental test score > 6 .
Who cannot join
- 1. Pathological fracture (excluding osteoporosis).
- 2. Rheumatoid arthritis.
- 3. Symptomatic arthrosis of the involved hip.
- 4. Neurological disorder that may significantly influence walking ability and/or tendency to dislocate.
- 5. Chronic corticosteroid use.
- 6. Concomitant other fracture.
- 7. Very high surgical risk.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Orthopaedic dept., E. Wolfson Medical center
Holon, 58100
Dror Lakstein, MD, ++972-3-5028383, drorale@gmail.com
About this study
The purpose of this study is to compare hemiarthroplasty (HAP) with total hip arthroplasty (THA), performed by trained arthroplasty surgeons with the use of large femoral heads for the treatment of displaced femoral neck fractures in mobile independent elderly patients, to determine the impact of these surgical options on the short term functional outcomes and complication rates, namely dislocation and the need for further surgery.
This is a single-blinded prospective randomized clinical trial comparing functional outcome and complication rates of 40 patients treated with all cemented THA to a control group of 40 patients treated with cemented bipolar HAP, in a 2 years followup.
The primary endpoint is the Oxford hip score (OHS) at last followup as a measure of functional outcome. Secondary endpoints include the SF-36 score, walking distance and rates of postoperative dislocation, component loosening, need for revision and postoperative mortality.
- Conditions
- Femoral Neck Fractures
- Being tested
- Total hip arthroplasty, Hemiarthroplasty
- Keywords
- Femoral neck fractures, Hip fractures, Elderly, Total hip arthroplasty, Bipolar hemiarthroplasty
- Medical subject headings
- Femoral Neck Fractures, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip arthroplastyProcedure or surgery
All cemented THA
HemiarthroplastyProcedure or surgery
Cemented bipolar HAP
| Study group | Role | What they receive |
|---|---|---|
| THA | Experimental | Total hip arthroplasty Receives: Procedure: Total hip arthroplasty |
| HAP | Active comparator | Bipolar Hemiarthroplasty Receives: Procedure: Hemiarthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford hip score (OHS)
Measured: last followup - 2 years
Secondary outcomes (2)
SF-36 score, walking distance
Measured: 2 years followup
dislocation rate, mortality rate
Measured: within follow up - 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2013 (estimated)
- Study completionDec 2013 (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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Investigators
- Dror Lakstein, MD, Principal investigator, E. Wolfson medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109862
- Sponsor's protocol ID
- 0019-10-WOMC
- Status last verified
- Apr 2010
- First submitted
- 22 Apr 2010
- Last updated
- 17 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparison of Bipolar Hemiarthroplasty and Total Hip Arthroplasty With Large Femoral Heads for the Treatment of Displaced Intracapsular Femoral Neck Fractures in the Elderly
- ClinicalTrials.gov ID
- NCT01109862
- Acronym / sponsor ID
- 0019-10-WOMC
- Conditions
- Femoral Neck Fractures
- Keywords
- Femoral neck fractures, Hip fractures, Elderly, Total hip arthroplasty, Bipolar hemiarthroplasty
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Apr 2010
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 23 Apr 2010 (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 purpose of this study is to compare hemiarthroplasty (HAP) with total hip arthroplasty (THA), performed by trained arthroplasty surgeons with the use of large femoral heads for the treatment of displaced femoral neck fractures in mobile independent elderly patients, to determine the impact of these surgical options on the short term functional outcomes and complication rates, namely dislocation and the need for further surgery.
This is a single-blinded prospective randomized clinical trial comparing functional outcome and complication rates of 40 patients treated with all cemented THA to a control group of 40 patients treated with cemented bipolar HAP, in a 2 years followup.
The primary endpoint is the Oxford hip score (OHS) at last followup as a measure of functional outcome. Secondary endpoints include the SF-36 score, walking distance and rates of postoperative dislocation, component loosening, need for revision and postoperative mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THA | Experimental | Procedure: Total hip arthroplastyTotal hip arthroplasty |
| HAP | Active comparator | Procedure: HemiarthroplastyBipolar Hemiarthroplasty |
Who may qualify
- Ages
- 70 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 1. Acute femoral neck fracture.
- 2. Age between 70 and 90 years old.
- 3. Independent community ambulator (more than 0.5km, without the aid of another person. The use of a cane is permitted) prior to fracture.
- 4. Abbreviated mental test score > 6 .
Key exclusion criteria (7 listed)
- 1. Pathological fracture (excluding osteoporosis).
- 2. Rheumatoid arthritis.
- 3. Symptomatic arthrosis of the involved hip.
- 4. Neurological disorder that may significantly influence walking ability and/or tendency to dislocate.
- 5. Chronic corticosteroid use.
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 |
|---|---|---|
| Total hip arthroplastyAll cemented THA | Procedure or surgery | THA |
| HemiarthroplastyCemented bipolar HAP | Procedure or surgery | HAP |
Primary outcome
Oxford hip score (OHS)
Time frame: last followup - 2 years
2 secondary outcomes
SF-36 score, walking distance
Time frame: 2 years followup
dislocation rate, mortality rate
Time frame: within follow up - 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2011.
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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.
Dror Lakstein, MD principal investigator
E. Wolfson medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Total hip arthroplasty and Hemiarthroplasty in people with Femoral Neck Fractures, run by Wolfson Medical Center at 1 site in Israel.
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 4 inclusion and 7 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 17 Jun 2011. 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 Israel. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Dror Lakstein, MD (++972-3-5028383, drorale@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford hip score (OHS) (time frame: last followup - 2 years). 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 17 Jun 2011.