Hip FracturesNCT05173155
Comparison of Direct Anterior Approach vs. Lateral Hemiarthroplasty for Femoral Neck Fracture Repair
A study testing surgical approach in people with Hip Fractures, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Recent research has demonstrated that a hemiarthroplasty (replacement of half the joint) has lower rates of post-surgical complications than a total hip arthroplasty does. However, surgeons tend to vary in their approach to hemiarthroplasties. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- surgical approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 30 May 2022to Feb 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient undergoing a hemiarthroplasty for a femoral neck fracture;
- Patients capable of reading, writing and signing an informed consent form
Who cannot join
- Patients under the age of 18
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, k1h 8l6
Isabel S Horton, 6137378899 ext. 73032, ihorton@ohri.ca
About this study
Official title: Comparison of Direct Anterior Approach vs. Lateral Hemiarthroplasty for Femoral Neck Fracture Repair: A Short-term Outcomes Study
Recent research has demonstrated that a hemiarthroplasty (replacement of half the joint) has lower rates of post-surgical complications than a total hip arthroplasty does. However, surgeons tend to vary in their approach to hemiarthroplasties. The lateral approach, which involves making an incision at the side of the patient's hip, requires surgeons to cut through the muscle to access the hip, which has been associated with greater muscle damage and slower rates of recovery. On the other hand, the direct anterior approach does not require the cutting of the patient's muscle and is therefore associated with minimal muscle damage and faster rates of recovery. This study will aim to assess the impact of the surgical approach (Direct Anterior Approach vs. Lateral approach) during hemiarthroplasty on patients' short-term mobility, quality of life, function, pain, and safety parameters.
Read the detailed description
Hip fractures continue to increase with the aging Canadian population. Overall clinical and functional outcomes following hip fractures are poor, with only a third of patients returning to their pre-injury functional status (1). The hemiarthroplasty, which involves replacing the femoral head with a prosthesis after femoral neck fracture, is the procedure of choice in most intra-capsular hip fractures (2). Similar to the total hip arthroplasty, the hemiarthroplasty has been shown to be a safe and effective surgical technique. A recent study found that the hemiarthroplasty was associated with lower incidence of serious adverse events when compared to total hip arthroplasty (3). Approaches to the hip used by surgeons to perform arthroplasty procedures may vary. The lateral approach has been advocated by National bodies to be the approach of choice in arthroplasties for hip fractures because it is associated with a smaller dislocation compared to the posterior approach. However, the lateral approach is associated with significant morbidity to the musculature about the hip, which is already weak and degenerate in this population. Thus, the lateral approach may further impede recovery of this frail population. An attractive alternative of a surgical approach for this population may be the Direct Anterior Approach to the hip. This is an inter-nervous and inter-muscular approach, associated with minimal muscle damage. Furthermore, stability (i.e. dislocation risk) has been reported to be at least equal to that reported with the lateral approach. However, the Direct Anterior Approach is an approach associated with a learning curve of at least 100 cases and a potential increased risk of infection and peri-prosthetic fracture. The Direct Anterior Approach has shown to have superior outcomes compared to the lateral approach in total hip arthroplasty studies, however, no study to-date has compared these approaches in the setting of hip fractures where the lateral approach is considered the gold standard.
The investigators feel that this is an important question to answer and believe that The Ottawa Hospital has the appropriate expertise to conduct such study. This center has utilized the Direct Anterior Approach in total hip arthroplasty for the last 10 years and the team's extensive experienced has been published. At present, 5 arthroplasty surgeons routinely perform the Direct Anterior Approach for at least half of their hip arthroplasty patients. Furthermore, 3 of the staff surgeons are considered key opinion leaders on the Direct Anterior Approach having mentored many surgeons nationally and internationally in many teaching formats including courses and invited lectures.
The primary objective of this study is to assess the impact of the surgical approach for a hemiarthroplasty on patients' short-term mobility. The secondary objectives are to assess the impact of approach on quality of life, function, pain and safety parameters. The hypothesis is that the Direct Anterior Approach will lead to superior function and mobility at short-term follow-up.
- Conditions
- Hip Fractures
- Being tested
- surgical approach
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical approachProcedure or surgery
Comparison of short-term outcomes (patient mobility, quality of life, function, pain, and safety parameters) for the direct anterior approach and Lateral approach for hemiarthroplasty for patients who have experienced a femoral-neck hip fracture.
| Study group | Role | What they receive |
|---|---|---|
| Direct anterior approach for hemiarthroplasty | Experimental | Patients in this arm will receive a hemiarthroplasty using the direct anterior approach (DAA) Receives: Procedure: surgical approach |
| Lateral approach for hemiarthroplasty | Experimental | Patients in this arm will receive a hemiarthroplasty using the lateral approach Receives: Procedure: surgical approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term mobility
The primary outcome measure will be mobility, assessed using the Short Physical Performance Battery (SPPB) test at post-operative day six or at discharge (4). This outcome assessed at this timeframe has been shown to be predictive of long-term function.
Measured: six days post-op
Secondary outcomes (4)
EuroQol 5
Secondary outcomes measures will include evaluation of the patient's quality of life (using the EuroQol 5 questionnaire).
Measured: 2-weeks post-op
Visual Analogue Scale
The Visual Analogue Scale will be given to patients 2- weeks post op to assess their levels of pain.
Measured: 2-weeks post-op
Opioid Use
Opioid Use will be monitored for two weeks post-op via. phone calls and follow-up visits
Measured: 2-weeks post-op
Barthel 20 Index
Family will be asked to complete questionnaires if patients are unable to. Activities of daily living (Barthel 20) will be assessed at post-operative day six or at discharge, day 14, and week 6 by a physiotherapist or nurse.
Measured: ost-operative day six or at discharge, day 14, and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start30 May 2022
- Primary completionNov 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Model description
- Patients will either receive a hemiarthroplasty in the direct anterior approach or the lateral approach.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173155
- Sponsor's protocol ID
- 20210516-01H
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2021
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Direct Anterior Approach vs. Lateral Hemiarthroplasty for Femoral Neck Fracture Repair: A Short-term Outcomes Study
- ClinicalTrials.gov ID
- NCT05173155
- Acronym / sponsor ID
- 20210516-01H
- Conditions
- Hip Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 29 Dec 2021 (actual)
- 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.
Recent research has demonstrated that a hemiarthroplasty (replacement of half the joint) has lower rates of post-surgical complications than a total hip arthroplasty does. However, surgeons tend to vary in their approach to hemiarthroplasties. The lateral approach, which involves making an incision at the side of the patient's hip, requires surgeons to cut through the muscle to access the hip, which has been associated with greater muscle damage and slower rates of recovery. On the other hand, the direct anterior approach does not require the cutting of the patient's muscle and is therefore associated with minimal muscle damage and faster rates of recovery. This study will aim to assess the impact of the surgical approach (Direct Anterior Approach vs. Lateral approach) during hemiarthroplasty on patients' short-term mobility, quality of life, function, pain, and safety parameters.
Detailed description
Hip fractures continue to increase with the aging Canadian population. Overall clinical and functional outcomes following hip fractures are poor, with only a third of patients returning to their pre-injury functional status (1). The hemiarthroplasty, which involves replacing the femoral head with a prosthesis after femoral neck fracture, is the procedure of choice in most intra-capsular hip fractures (2). Similar to the total hip arthroplasty, the hemiarthroplasty has been shown to be a safe and effective surgical technique. A recent study found that the hemiarthroplasty was associated with lower incidence of serious adverse events when compared to total hip arthroplasty (3). Approaches to the hip used by surgeons to perform arthroplasty procedures may vary. The lateral approach has been advocated by National bodies to be the approach of choice in arthroplasties for hip fractures because it is associated with a smaller dislocation compared to the posterior approach. However, the lateral approach is associated with significant morbidity to the musculature about the hip, which is already weak and degenerate in this population. Thus, the lateral approach may further impede recovery of this frail population. An attractive alternative of a surgical approach for this population may be the Direct Anterior Approach to the hip. This is an inter-nervous and inter-muscular approach, associated with minimal muscle damage. Furthermore, stability (i.e. dislocation risk) has been reported to be at least equal to that reported with the lateral approach. However, the Direct Anterior Approach is an approach associated with a learning curve of at least 100 cases and a potential increased risk of infection and peri-prosthetic fracture. The Direct Anterior Approach has shown to have superior outcomes compared to the lateral approach in total hip arthroplasty studies, however, no study to-date has compared these approaches in the setting of hip fractures where the lateral approach is considered the gold standard.
The investigators feel that this is an important question to answer and believe that The Ottawa Hospital has the appropriate expertise to conduct such study. This center has utilized the Direct Anterior Approach in total hip arthroplasty for the last 10 years and the team's extensive experienced has been published. At present, 5 arthroplasty surgeons routinely perform the Direct Anterior Approach for at least half of their hip arthroplasty patients. Furthermore, 3 of the staff surgeons are considered key opinion leaders on the Direct Anterior Approach having mentored many surgeons nationally and internationally in many teaching formats including courses and invited lectures.
The primary objective of this study is to assess the impact of the surgical approach for a hemiarthroplasty on patients' short-term mobility. The secondary objectives are to assess the impact of approach on quality of life, function, pain and safety parameters. The hypothesis is that the Direct Anterior Approach will lead to superior function and mobility at short-term follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will either receive a hemiarthroplasty in the direct anterior approach or the lateral approach.
| Arm | Type | Receives |
|---|---|---|
| Direct anterior approach for hemiarthroplasty | Experimental | Procedure: surgical approachPatients in this arm will receive a hemiarthroplasty using the direct anterior approach (DAA) |
| Lateral approach for hemiarthroplasty | Experimental | Procedure: surgical approachPatients in this arm will receive a hemiarthroplasty using the lateral approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any patient undergoing a hemiarthroplasty for a femoral neck fracture;
- Patients capable of reading, writing and signing an informed consent form
Key exclusion criteria (1 listed)
- Patients under the age of 18
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 |
|---|---|---|
| surgical approachComparison of short-term outcomes (patient mobility, quality of life, function, pain, and safety parameters) for the direct anterior approach and Lateral approach for hemiarthroplasty for patients who have experienced a femoral-neck hip fracture. | Procedure or surgery | Direct anterior approach for hemiarthroplasty, Lateral approach for hemiarthroplasty |
Primary outcome
Short-term mobility
Time frame: six days post-op
The primary outcome measure will be mobility, assessed using the Short Physical Performance Battery (SPPB) test at post-operative day six or at discharge (4). This outcome assessed at this timeframe has been shown to be predictive of long-term function.
4 secondary outcomes
EuroQol 5
Time frame: 2-weeks post-op
Visual Analogue Scale
Time frame: 2-weeks post-op
Opioid Use
Time frame: 2-weeks post-op
Barthel 20 Index
Time frame: ost-operative day six or at discharge, day 14, and week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgical approach in people with Hip Fractures, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 2 inclusion and 1 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 13 Nov 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 Canada. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term mobility (time frame: six days post-op). 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 13 Nov 2023.