Femoral Neck FracturesNCT02959320
Direct Anterior vs. Anterolateral Approach for Hip Arthroplasty After Femoral Neck Fracture in the Senior Population
A study testing Hip Hemiarthroplasty in people with Femoral Neck Fractures, run by Mayo Clinic at 1 site in United States.
Trial summary
Displaced femoral neck fractures are one group of hip fracture patients that are commonly treated with cemented hemiarthroplasty (HA) or total hip arthroplasty (THA). In the elective hip arthroplasty population, the direct anterior approach (DAA) has shown to be effective in helping patients to quickly obtain high… 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?
- Hip Hemiarthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 2 Jun 2022
- 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
- isolated displaced femoral neck fracture (AO type 31-B2 and 31 B3)
- age≥65 years
- preinjury ambulation with or without a gait aid
- surgical intervention ≤ 48 hours after fracture.
Who cannot join
- age <65 years
- patients with other fractures or dislocations
- wheelchair bound
- >48 hours between fracture and surgery, presence or history of infection, active metastatic disease, previous ipsilateral hip prosthesis
- active major psychiatric illness
- active drug or alcohol abuse
- BMI >40, and actively failing contralateral hip prosthesis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial of Direct Anterior vs. Anterolateral Approach for Hip Arthroplasty After Femoral Neck Fracture in the Senior Population
Displaced femoral neck fractures are one group of hip fracture patients that are commonly treated with cemented hemiarthroplasty (HA) or total hip arthroplasty (THA). In the elective hip arthroplasty population, the direct anterior approach (DAA) has shown to be effective in helping patients to quickly obtain high postoperative function. This approach has also been shown to be effective in arthroplasty for displaced femoral neck fractures in a few studies. However, the only studies that directly compare two approaches for hip arthroplasty for femoral neck fractures utilize the anterolateral approach (ALA) versus posterior approach (PA) or DAA versus PA. No studies of which we are aware directly compare the DAA to the ALA. The DAA and ALA are the two most popular approaches for bipolar hemiarthroplasty at our institution, so we are setting out to determine the differences between them.
Read the detailed description
Displaced femoral neck fractures are one group of hip fracture patients that are commonly treated with cemented hemiarthroplasty (HA) or total hip arthroplasty (THA). Compared to those who receive a THA, recipients of HA tend to be less active, more debilitated, and more dependent on gait aids and the care of others. In this population, the increased stability and decreased operating time associated with HA is thought to be more important than the minimal increase in function this population could achieve with THA. Additionally, cemented femoral stems in HA are thought to result in less pain, increased function, and less periprosthetic fracture risk when compared to cementless stems.
With the relative pre-injury debility of the femoral neck fracture population, especially those receiving HA, it is important to optimize all aspects of patient care to allow them to participate in therapy and return them to their preoperative functional level as quickly as possible. Furthermore, any intervention in this population should minimize the physiologic insult of surgery as much as possible. In the elective hip arthroplasty population, the direct anterior approach (DAA) has shown to be effective in helping patients to quickly obtain high postoperative function. This approach has also been shown to be effective in arthroplasty for displaced femoral neck fractures in a few studies. However, the only studies that directly compare two approaches for hip arthroplasty for femoral neck fractures utilize the anterolateral approach (ALA) versus posterior approach (PA) or DAA versus PA. No studies of which we are aware directly compare the DAA to the ALA. The DAA and ALA are the two most popular approaches for bipolar hemiarthroplasty at our institution, so investigators are setting out to determine the differences between them.
- Conditions
- Femoral Neck Fractures
- Being tested
- Hip 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.
Hip HemiarthroplastyProcedure or surgery
This single-institution, prospective, randomized clinical trial will be performed on consecutive elderly patients admitted for surgical treatment of displaced femoral neck fractures with hemiarthroplasty (HA).
| Study group | Role | What they receive |
|---|---|---|
| Direct Anterior Approach | Active comparator | All patients receiving a hip hemiarthroplasty through a Direct Anterior Approach (DAA) will have their surgeries performed with the aid of fluoroscopy on an OSI Hana table that allows the operative limb to be manipulated through range of motion and traction while keeping the pelvis stabilized. This table also has a radiolucent platform about the pelvis, enabling the surgery to be fluoroscopically assisted. The incision for the DAA will extend from a proximal point about 2 cm distal and 2 cm lateral to the ASIS to a point 8-12 cm distal and slightly lateral to this. Receives: Procedure: Hip Hemiarthroplasty |
| Anterolateral Approach | Active comparator | All patients receiving a hip hemiarthroplasty through an the Anterolateral Approach (ALA) will have their surgeries performed on a standard OR table in a contralateral lateral decubitus position. With the leg in the position of sleep, a straight 8-12 cm incision will be made, centered over the greater trochanter and femoral shaft with 1/3 of the incision extending superior to the tip of the greater trochanter. Receives: Procedure: Hip Hemiarthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients showing improvement using the Timed Up and Go (TUG) Test
Purpose of test is to assess mobility and will be administered by a nurse who is blinded to the surgical approach.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion7 Sep 2021
- Study completion2 Jun 2022
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.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William W. Cross, III M.D., Mayo Clinic
- Investigators
- Cross W. William, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959320
- Sponsor's protocol ID
- 16-003695
- Status last verified
- Jan 2023
- First submitted
- 7 Nov 2016
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Direct Anterior vs. Anterolateral Approach for Hip Arthroplasty After Femoral Neck Fracture in the Senior Population
- ClinicalTrials.gov ID
- NCT02959320
- Acronym / sponsor ID
- 16-003695
- Conditions
- Femoral Neck Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 7 Sep 2021 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 9 Nov 2016 (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.
Displaced femoral neck fractures are one group of hip fracture patients that are commonly treated with cemented hemiarthroplasty (HA) or total hip arthroplasty (THA). In the elective hip arthroplasty population, the direct anterior approach (DAA) has shown to be effective in helping patients to quickly obtain high postoperative function. This approach has also been shown to be effective in arthroplasty for displaced femoral neck fractures in a few studies. However, the only studies that directly compare two approaches for hip arthroplasty for femoral neck fractures utilize the anterolateral approach (ALA) versus posterior approach (PA) or DAA versus PA. No studies of which we are aware directly compare the DAA to the ALA. The DAA and ALA are the two most popular approaches for bipolar hemiarthroplasty at our institution, so we are setting out to determine the differences between them.
Detailed description
Displaced femoral neck fractures are one group of hip fracture patients that are commonly treated with cemented hemiarthroplasty (HA) or total hip arthroplasty (THA). Compared to those who receive a THA, recipients of HA tend to be less active, more debilitated, and more dependent on gait aids and the care of others. In this population, the increased stability and decreased operating time associated with HA is thought to be more important than the minimal increase in function this population could achieve with THA. Additionally, cemented femoral stems in HA are thought to result in less pain, increased function, and less periprosthetic fracture risk when compared to cementless stems.
With the relative pre-injury debility of the femoral neck fracture population, especially those receiving HA, it is important to optimize all aspects of patient care to allow them to participate in therapy and return them to their preoperative functional level as quickly as possible. Furthermore, any intervention in this population should minimize the physiologic insult of surgery as much as possible. In the elective hip arthroplasty population, the direct anterior approach (DAA) has shown to be effective in helping patients to quickly obtain high postoperative function. This approach has also been shown to be effective in arthroplasty for displaced femoral neck fractures in a few studies. However, the only studies that directly compare two approaches for hip arthroplasty for femoral neck fractures utilize the anterolateral approach (ALA) versus posterior approach (PA) or DAA versus PA. No studies of which we are aware directly compare the DAA to the ALA. The DAA and ALA are the two most popular approaches for bipolar hemiarthroplasty at our institution, so investigators are setting out to determine the differences between them.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct Anterior Approach | Active comparator | Procedure: Hip HemiarthroplastyAll patients receiving a hip hemiarthroplasty through a Direct Anterior Approach (DAA) will have their surgeries performed with the aid of fluoroscopy on an OSI Hana table that allows the operative limb to be manipulated through range of motion and traction while keeping the pelvis stabilized. This table also has a radiolucent platform about the pelvis, enabling the surgery to be fluoroscopically assisted. The incision for the DAA will extend from a proximal point about 2 cm distal and 2 cm lateral to the ASIS to a point 8-12 cm distal and slightly lateral to this. |
| Anterolateral Approach | Active comparator | Procedure: Hip HemiarthroplastyAll patients receiving a hip hemiarthroplasty through an the Anterolateral Approach (ALA) will have their surgeries performed on a standard OR table in a contralateral lateral decubitus position. With the leg in the position of sleep, a straight 8-12 cm incision will be made, centered over the greater trochanter and femoral shaft with 1/3 of the incision extending superior to the tip of the greater trochanter. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- isolated displaced femoral neck fracture (AO type 31-B2 and 31 B3)
- age≥65 years
- preinjury ambulation with or without a gait aid
- surgical intervention ≤ 48 hours after fracture.
Key exclusion criteria (7 listed)
- age <65 years
- patients with other fractures or dislocations
- wheelchair bound
- >48 hours between fracture and surgery, presence or history of infection, active metastatic disease, previous ipsilateral hip prosthesis
- active major psychiatric illness
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 |
|---|---|---|
| Hip HemiarthroplastyThis single-institution, prospective, randomized clinical trial will be performed on consecutive elderly patients admitted for surgical treatment of displaced femoral neck fractures with hemiarthroplasty (HA). | Procedure or surgery | Anterolateral Approach, Direct Anterior Approach |
Primary outcome
Number of patients showing improvement using the Timed Up and Go (TUG) Test
Time frame: Baseline to 12 months
Purpose of test is to assess mobility and will be administered by a nurse who is blinded to the surgical approach.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Cross W. William, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip Hemiarthroplasty in people with Femoral Neck Fractures, run by Mayo Clinic at 1 site 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 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: finished, as of the sponsor's last update on 6 Jan 2023. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients showing improvement using the Timed Up and Go (TUG) Test (time frame: Baseline to 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 6 Jan 2023.