Anterior vs Posterior Approach for Hip Hemiarthroplasty
Primary Purpose
Hip Fractures
Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
anterior approach to the hip
posterior approach to the hip
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fractures
Eligibility Criteria
Inclusion Criteria:
- Eligible patients will include all patients that were previously ambulatory at some level who sustain a displaced femoral neck fracture that given functional status, age, and comorbidities will require a hemi-arthroplasty for definitive treatment.
- Ages 65-99
Exclusion Criteria:
- Patients who will be excluded from the study are all patients who are non ambulatory at baseline.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Anterior approach
Posterior Approach
Arm Description
Patient's undergoing an anterior approach to the hip
Patient's undergoing an posterior approach to the hip
Outcomes
Primary Outcome Measures
Functional outcomes
Harris Hip Score. Score ranges from 0-100 The higher the HHS, the less dysfunction. A total score of <70 is considered a poor result; 70-80 is considered fair, 80-90 is good, and 90-100 is an excellent result
Secondary Outcome Measures
Full Information
NCT ID
NCT04957251
First Posted
March 23, 2018
Last Updated
August 15, 2023
Sponsor
Mount Carmel Health System
1. Study Identification
Unique Protocol Identification Number
NCT04957251
Brief Title
Anterior vs Posterior Approach for Hip Hemiarthroplasty
Official Title
Does the Anterior or Posterior Approach to the Hip Provide Superior Functional Recovery After Recovery After Performing Hip Hemiarthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 28, 2015 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mount Carmel Health System
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
Randomized trial to evaluate the role of the anterior vs posterior approach regarding hemiarthroplasty of the hip. The Investigators' hypothesis is that the muscle sparing anterior approach may result in improved function in the short term, which may allow shorter hospital stay and quicker return to prior level of function.
Detailed Description
Background
In patients who sustain a displaced femoral neck fracture, who do not meet criteria for total hip arthroplasty, the recommendations are made for a hemi-arthroplasty of the hip. There are multiple surgical approaches that can be used including the anterior approach to the hip and the posterior approach to the hip. The most widely performed approach to the hip when performing a total hip arthroplasty or hemi-arthroplasty has been the posterior approach. However, multiple approaches exist including posterior approach, direct lateral approach, anterolateral approach and direct anterior approach. There is not a consensus about which approach is the most appropriate or best for patients. The decision for approach is widely decided by the surgeon and is based on experience and preference of the surgeon. Recent advances in the anterior approach to the hip have found improved results with regards to functional status and decreased complications when compared to the posterior approach for total hip arthroplasty. There have been several retrospective studies comparing the anterior vs. posterior approach for hemi-arthroplasty with regards to treatment of femoral neck fractures. These studies have shown conflicting results with regards to which approach is superior. Retrospective studies have shown decreased dislocation rate with the anterior approach, but increased operative time and increased rate of infection with anterior approach as well. To date, there have been two prospective studies performed comparing the anterior and posterior approach for hemi-arthroplasty, one in Japan and one in France, both of which showed decreased dislocation rates but did not display long term functional improvement comparing the two approaches. Both of these studies' patient population and protocol differ greatly from standard of care in the United States. To date, there have been no prospective randomized controlled trials evaluating the functional advantage of the anterior vs. the posterior approach when performing hip hemi-arthroplasty procedure for femoral neck fractures in the United States. It is our hypothesis that the anterior approach will provide superior functional results as a product of the decreased damage to soft tissue and restoration of normal anatomy.
Objectives:
There are several objectives of this study.
The main objective of this study is to evaluate the functional status of each patient using a Harris Hip Score to evaluate both function and pain comparing the anterior vs. the posterior approach for hemi-arthroplasty at 6 months.
Secondary objectives of this study include:
time to ambulation post operatively
rate of complications including infection, nerve palsy, and DVT/PE
operative time
rate of dislocation
periprosthetic fracture
mortality
return to preoperative mobility status
blood loss
Significance:
The results of this study would either confirm the retrospective data that currently exists showing no difference in functional outcomes between the two approaches or demonstrate a superior functional status with either the anterior or posterior approach for hip hemi-arthroplasty. Of which, logically and anecdotally, the Investigators' believe will be the anterior approach. With this research, theInvestigators' believe the anterior approach can become the standard of care for the surgical technique with regards to hemi-arthroplasty for hip fractures
Eligible patients:
Eligible patients will include all patients that were previously ambulatory at some level who sustain a displaced femoral neck fracture that given functional status, age, and comorbidities will require a hemi-arthroplasty for definitive treatment. Ages 65-99
Patients who will be excluded from the study are all patients who are non ambulatory at baseline.
Design:
Patients who meet eligibility criteria will be offered to participate in the study. Once the patient consents, the participants will be randomized to receive either the anterior or posterior approach for hemi-arthroplasty of the hip. After surgery, the participant will undergo standard postoperative care (hip precautions) with data collected from the electronic health record and from standard hospital care including rounding. The participant will then follow up at appropriate standard interval with the main endpoint of 6 months where Harris Hip Scores will be used to judge the participant's functional status as well as pain relief.
Analysis of the collected data will occur at intervals of 50 patients to evaluate trends or statistical significance.
Monitoring Participants:
If at any time during this study the participant or medical decision maker decides to no longer participate in the study, the participant will be removed from the study and will continue to undergo standard treatment for their condition.
Consent:
Consent will be obtained so long as the participant meets the appropriate criteria listed above and will be given a detailed informed consent document outlining the purpose of the study and associated risks and benefits.
Human Subject Protections:
There is currently no widely accepted technique based on outcomes with regards to operative approach for hip hemi-arthroplasty, nor is there a standard approach for total hip arthroplasty. Therefore, the participant will not have to do anything different from an intervention standpoint and therefore are not at any increased risk based on our study protocol. All participants will receive treatment of hip fracture in an appropriate fashion. They will be asked standard postoperative questions during their stay and will undergo standard follow up. The only change from current standard of care in follow up will include the primary investigator performing a Harris Hip questionnaire and assessment at each postoperative visit.
With regards to selection, the only criteria will be a baseline ambulatory status prior to sustaining a displaced femoral neck fracture. The participants who are demented will be included in the study because a large percentage of patients who sustain femoral neck fractures and require a hemi-arthroplasty have some baseline dementia. These participants will only be included if a medical power of attorney or appropriate medical decision maker is available.
Analysis
Data will be collected and analyzed after 50 participants using a student t-test analysis to evaluate for statistical significance or tends. The goal of 200 patients is to obtain the largest prospective controlled trial to date. Analysis every 50 is based off of previous literature that showed statistical significance near 50 patients in some categories including dislocation.
Adverse Events Reporting
This study is a single surgeon study that is not blinded and all adverse events outside of the expected complications associated with hip hemi-arthroplasty will be reported immediately to the IRB board.
Patient confidentiality
The only PHI data that will be kept will be the FIN number to pull information from the electronic health record during analysis. This is necessary as a means to be able to accurately report lab values, operative times, and other pertinent information from their hospital stay. Otherwise, all hard copy data will be locked in a safe location, and all electronic data will be password protected.
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anterior approach
Arm Type
Experimental
Arm Description
Patient's undergoing an anterior approach to the hip
Arm Title
Posterior Approach
Arm Type
Active Comparator
Arm Description
Patient's undergoing an posterior approach to the hip
Intervention Type
Procedure
Intervention Name(s)
anterior approach to the hip
Intervention Description
anterior hip hemiarthroplasty
Intervention Type
Procedure
Intervention Name(s)
posterior approach to the hip
Intervention Description
posterior hip hemiarthroplasty
Primary Outcome Measure Information:
Title
Functional outcomes
Description
Harris Hip Score. Score ranges from 0-100 The higher the HHS, the less dysfunction. A total score of <70 is considered a poor result; 70-80 is considered fair, 80-90 is good, and 90-100 is an excellent result
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Eligible patients will include all patients that were previously ambulatory at some level who sustain a displaced femoral neck fracture that given functional status, age, and comorbidities will require a hemi-arthroplasty for definitive treatment.
Ages 65-99
Exclusion Criteria:
Patients who will be excluded from the study are all patients who are non ambulatory at baseline.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Database that is kept on site that may be reviewed.
Learn more about this trial
Anterior vs Posterior Approach for Hip Hemiarthroplasty
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