Comparison of Direct Anterior Approach vs. Lateral Hemiarthroplasty for Femoral Neck Fracture Repair
Primary Purpose
Hip Fractures
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
surgical approach
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fractures
Eligibility Criteria
Inclusion Criteria:
- Any patient undergoing a hemiarthroplasty for a femoral neck fracture;
- Patients capable of reading, writing and signing an informed consent form
Exclusion Criteria:
- Patients under the age of 18
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Direct anterior approach for hemiarthroplasty
Lateral approach for hemiarthroplasty
Arm Description
Patients in this arm will receive a hemiarthroplasty using the direct anterior approach (DAA)
Patients in this arm will receive a hemiarthroplasty using the lateral approach
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
EuroQol 5
Secondary outcomes measures will include evaluation of the patient's quality of life (using the EuroQol 5 questionnaire).
Visual Analogue Scale
The Visual Analogue Scale will be given to patients 2- weeks post op to assess their levels of pain.
Opioid Use
Opioid Use will be monitored for two weeks post-op via. phone calls and follow-up visits
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.
Full Information
NCT ID
NCT05173155
First Posted
November 9, 2021
Last Updated
December 10, 2021
Sponsor
Ottawa Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05173155
Brief Title
Comparison of Direct Anterior Approach vs. Lateral Hemiarthroplasty for Femoral Neck Fracture Repair
Official Title
Comparison of Direct Anterior Approach vs. Lateral Hemiarthroplasty for Femoral Neck Fracture Repair: A Short-term Outcomes Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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. Our 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. We hypothesize that the Direct Anterior Approach will lead to superior function and mobility at short-term follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will either receive a hemiarthroplasty in the direct anterior approach or the lateral approach.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Direct anterior approach for hemiarthroplasty
Arm Type
Experimental
Arm Description
Patients in this arm will receive a hemiarthroplasty using the direct anterior approach (DAA)
Arm Title
Lateral approach for hemiarthroplasty
Arm Type
Experimental
Arm Description
Patients in this arm will receive a hemiarthroplasty using the lateral approach
Intervention Type
Procedure
Intervention Name(s)
surgical approach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Short-term mobility
Description
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.
Time Frame
six days post-op
Secondary Outcome Measure Information:
Title
EuroQol 5
Description
Secondary outcomes measures will include evaluation of the patient's quality of life (using the EuroQol 5 questionnaire).
Time Frame
2-weeks post-op
Title
Visual Analogue Scale
Description
The Visual Analogue Scale will be given to patients 2- weeks post op to assess their levels of pain.
Time Frame
2-weeks post-op
Title
Opioid Use
Description
Opioid Use will be monitored for two weeks post-op via. phone calls and follow-up visits
Time Frame
2-weeks post-op
Title
Barthel 20 Index
Description
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.
Time Frame
ost-operative day six or at discharge, day 14, and week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any patient undergoing a hemiarthroplasty for a femoral neck fracture;
Patients capable of reading, writing and signing an informed consent form
Exclusion Criteria:
Patients under the age of 18
12. IPD Sharing Statement
Learn more about this trial
Comparison of Direct Anterior Approach vs. Lateral Hemiarthroplasty for Femoral Neck Fracture Repair
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