Femur FractureTHANCT01484405
Anterolateral Versus Posterior Approach for Total Hip Arthroplasty After Displaced Femoral Neck Fracture
A study testing posterior approach and anterolateral approach in people with Femur Fracture, run by Florida Orthopaedic Institute at 2 sites in United States.
Trial summary
There are two surgical approaches (incision types) used by surgeons who do total hip replacements. The purpose of this study is to determine which type of surgical approach (incision type) produces the best results for patients who have a total hip replacement. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Femur Fracture
- What is being tested?
- posterior approach and anterolateral approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2010to Nov 2013
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Displaced femoral neck fracture
- Age 65 years or older
- Acute, femoral neck fracture
Who cannot join
- Cognitive impairment
- Active Infection
- Limited functional capacity (nursing home resident, non-ambulatory, severe cardiorespiratory disease)
- Limited life expectancy
- Pathologic fracture (tumor)
- Acetabular fractures
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tampa general Hospital
Tampa, Florida, 33606
St Josephs Hospital
Tampa, Florida, 33607
About this study
There are two surgical approaches (incision types) used by surgeons who do total hip replacements. The purpose of this study is to determine which type of surgical approach (incision type) produces the best results for patients who have a total hip replacement.
Null Hypothesis : There is no difference in complication rate, functional outcome, surgical time, or blood loss when comparing outcomes in patients receiving THA to hemiarthroplasty or ORIF for femoral neck fractures.
Read the detailed description
Patients undergoing Total hip Arthroplasty following displaced femoral neck fracture, will be consented and randomized to one of two surgical approaches ( anterior or posterior).
- Conditions
- Femur Fracture
- Being tested
- posterior approach, anterolateral approach
- Keywords
- surgical approach for total hip arthroplasty
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterior approachProcedure or surgery
Also called Total hip Athroplasty following fracture
Surgical approach for Total Hip Arthroplasty
anterolateral approachProcedure or surgery
Also called Total hip Athroplasty following fracture
anterolateral surgical approach
| Study group | Role | What they receive |
|---|---|---|
| anterolateral approach | Other | surgical intervention THA anterolateral approach Receives: Procedure: anterolateral approach |
| posterior approach | Other | surgical intervention THA posterior approach Receives: Procedure: posterior approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
dislocation rates
Radiographic variables: AP and lateral views of hip and pelvis
Measured: 12 months
Secondary outcomes (1)
other complications
Hospital readmission, reoperation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startJun 2010
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: Low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femur 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
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Orthopaedic Institute
- Sponsor type
- Research network
- Collaborators
- Orthopaedic Trauma Association
- Responsible party
- Sponsor
- Investigators
- David Watson, MD, Principal investigator, Florida Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484405
- Sponsor's protocol ID
- THA
- Acronym
- THA
- Status last verified
- Nov 2014
- First submitted
- 30 Nov 2011
- Last updated
- 11 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterolateral Versus Posterior Approach for Total Hip Arthroplasty After Displaced Femoral Neck Fracture
- ClinicalTrials.gov ID
- NCT01484405
- Acronym / sponsor ID
- THA / THA
- Conditions
- Femur Fracture
- Keywords
- surgical approach for total hip arthroplasty
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Florida Orthopaedic InstituteResearch network
- Collaborators
- Orthopaedic Trauma Association
- Study start
- Jun 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 2 Dec 2011 (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.
There are two surgical approaches (incision types) used by surgeons who do total hip replacements. The purpose of this study is to determine which type of surgical approach (incision type) produces the best results for patients who have a total hip replacement.
Null Hypothesis : There is no difference in complication rate, functional outcome, surgical time, or blood loss when comparing outcomes in patients receiving THA to hemiarthroplasty or ORIF for femoral neck fractures.
Detailed description
Patients undergoing Total hip Arthroplasty following displaced femoral neck fracture, will be consented and randomized to one of two surgical approaches ( anterior or posterior).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anterolateral approach | Other | Procedure: anterolateral approachsurgical intervention THA anterolateral approach |
| posterior approach | Other | Procedure: posterior approachsurgical intervention THA posterior approach |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Displaced femoral neck fracture
- Age 65 years or older
- Acute, femoral neck fracture
Key exclusion criteria (6 listed)
- Cognitive impairment
- Active Infection
- Limited functional capacity (nursing home resident, non-ambulatory, severe cardiorespiratory disease)
- Limited life expectancy
- Pathologic fracture (tumor)
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 |
|---|---|---|
| posterior approachAlso: Total hip Athroplasty following fractureSurgical approach for Total Hip Arthroplasty | Procedure or surgery | posterior approach |
| anterolateral approachAlso: Total hip Athroplasty following fractureanterolateral surgical approach | Procedure or surgery | anterolateral approach |
Primary outcome
dislocation rates
Time frame: 12 months
Radiographic variables: AP and lateral views of hip and pelvis
1 secondary outcome
other complications
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Low enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2014.
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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.
David Watson, MD principal investigator
Florida Orthopaedic Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing posterior approach and anterolateral approach in people with Femur Fracture, run by Florida Orthopaedic Institute at 2 sites in United States.
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: stopped early, as of the sponsor's last update on 11 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study was stopped early (reason given: Low enrollment.). 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?
dislocation rates (time frame: 12 months). 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 11 Nov 2014.