Direct Anterior Approach Versus Mini Posterior Approach Versous Lateral Approach for Displaced Femoral Neck Fractures
Primary Purpose
Hip Fractures, Femoral Neck Fractures
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Direct Anterior Approach Hemiarthroplasty
Mini Posterior Approach
Lateral approach
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fractures focused on measuring hip, fractures, surgical approach, outcome, bleeding
Eligibility Criteria
Inclusion Criteria:
- Consecutive patients undergoing hip fracture surgery for displaced femoral neck fractures (Garden 3 and 4 fractures) and treated by cemented hemiarthroplasty will be included in the study. Patients must have the ability to give informed consent or a legal guardian is available.
Exclusion Criteria:
- The exclusion criteria include open or pathological fractures, re-fractures, infection, concomitant injuries of the ipsi- or contralateral leg or upper limb, skin diseases in the area of proposed incisions, patients that are mentally incapable of understanding the consequences of the study and reduced compliance.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Direct anterior approach
Mini Posterior Approach
Lateral approach
Arm Description
Patients with a femoral neck fracture, treated by hemiarthroplasty by direct anterior approach, using a regular OR table, without hip hyperextension.
Patients with a femoral neck fracture, treated by hemiarthroplasty by a mini posterior approach.
Patients with a femoral neck fracture, treated by hemiarthroplasty by a lateral (Hardinge) approach.
Outcomes
Primary Outcome Measures
The Five Item Barthel Index
Patient mobilization and motoric status measured with a five-item-Barthel index.
The Barthel scale is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. The Barthel Index is a widely used measure of physical dependence in personal activities of daily living (PADL). The short five-item Barthel index score ranges from 0-15 points, with 0 means the worst score and 15 the optimal score that a patient can achieve.
The Five Item Barthel Index
Patient mobilization and motoric status measured with a five-item-Barthel index.
The Barthel scale is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. The Barthel Index is a widely used measure of physical dependence in personal activities of daily living (PADL). The short five-item Barthel index score ranges from 0-15 points, with 0 means the worst score and 15 the optimal score that a patient can achieve.
The Timed Up and Go test (TUG)
The Timed Up and Go test, is a test of balance that is commonly used to examine functional mobility in community-dwelling, frail older adults. The test requires a subject to stand up, walk 3 m (10 ft), turn, walk back, and sit down. Time taken to complete the test is strongly correlated to the level of functional mobility.
Older adults who are able to complete the task in less than 20 seconds have been shown to be independent in transfer tasks involved in activities of daily living, and walk at gait speeds that should be sufficient for community mobility (0.5 m/s). In contrast, older adults requiring 30 seconds or longer to complete the task tend to be more dependent on activities of daily living and require assistive devices for ambulation.
The Timed Up and Go test (TUG)
The Timed Up and Go test, is a test of balance that is commonly used to examine functional mobility in community-dwelling, frail older adults. The test requires a subject to stand up, walk 3 m (10 ft), turn, walk back, and sit down. Time taken to complete the test is strongly correlated to the level of functional mobility.
Older adults who are able to complete the task in less than 20 seconds have been shown to be independent in transfer tasks involved in activities of daily living, and walk at gait speeds that should be sufficient for community mobility (0.5 m/s). In contrast, older adults requiring 30 seconds or longer to complete the task tend to be more dependent on activities of daily living and require assistive devices for ambulation.
Parker mobility score
Postoperative mobility score, as proposed by Parker and Palmer (Parker MJ, Palmer CR, JBJS Br (1993) ).
The Parker Mobility Score is a composite measurement of the patient's mobility indoors, outdoors and during shopping, and is used in studies either to measure the mobility as an outcome measure or as a predictor for mortality
Range 0-9 points (0 is the worst score and 9 the best score that a patient can achieve)
Parker mobility score
Postoperative mobility score, as proposed by Parker and Palmer (Parker MJ, Palmer CR, JBJS Br (1993) ).
The Parker Mobility Score is a composite measurement of the patient's mobility indoors, outdoors and during shopping, and is used in studies either to measure the mobility as an outcome measure or as a predictor for mortality
Range 0-9 points (0 is the worst score and 9 the best score that a patient can achieve)
Secondary Outcome Measures
Change to the Total blood loss (TBL)
For calculation of the total blood loss (TBL) expressed to total Hb loss and total Volume loss , we will use the number of transfusions (55 grams of haemoglobin per transfusion), the haemoglobin concentration on preoperatively (Hgbi) and the haemoglobin concentration on the last available measure of haemoglobin concentration (Hgbe). (Hemoglobin balance method)
Change at the Pain Visual Analog (VAS) score
The pain visual analog scale (VAS) is commonly used as the outcome measure for pain. It is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" (0 pain) and "worst pain imaginable." (100 pain)
Muscle Damage Markers
CK (Creatine Kinase), ECR and CRP
Change at Creatine Kinase (CK)
The appearance of creatine kinase (CK) in blood has been generally considered to be an indirect marker of muscle damage.
Reference Values Males >3 months: 39-308 U/L Females >3 months: 26-192 U/L
Change at C-Reactive protein (CRP)
C-reactive protein (CRP) levels have been documented as a potent marker for skeletal muscle damage.
Reference Value: 0-10mg/L
Full Information
NCT ID
NCT04618549
First Posted
June 17, 2020
Last Updated
October 31, 2020
Sponsor
National and Kapodistrian University of Athens
1. Study Identification
Unique Protocol Identification Number
NCT04618549
Brief Title
Direct Anterior Approach Versus Mini Posterior Approach Versous Lateral Approach for Displaced Femoral Neck Fractures
Official Title
Direct Anterior Approach (in Regular OR Table) Versus Mini Posterior Approach Versus Lateral Approach for the Treatment of Displaced Femoral Neck Fractures: A Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Anticipated)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
March 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National and Kapodistrian University of Athens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In general, hip fractures in the elderly are associated with a high one year-mortality up to 36 %. Apart from choosing the proper treatment, optimizing the surgical technique itself offers options to improve the outcome. Early mobilization after hip hemi¬arthroplasty correlates with improved ambulation, reduced need for assisted transfers, and less use of extended care facilities after hospital discharge.
Nowadays, in order to reduce soft tissue damage and gain quicker postoperative recovery and faster rehabilitation, various MIS techniques have been proposed. Two of these techniques are the mini posterior approach and the mini direct anterior approach. The direct anterior approach was developed as a true internervous and intermuscular surgical approach with proposed benefits of faster recovery, quicker return to function, and less pain. In theory, the direct anterior approach should cause less tissue damage than mini posterior approach, as it is performed through a plane between neurlogical tissue and intermuscular plane without muscle transection.
The aim of this study is to evaluate the clinical and radiological outcomes of the direct anterior approach for bipolar head endoprosthetic hemiarthroplasty in patients with displaced femoral neck fractures in comparison with the mini posterior approach and the traditional lateral approach, for the treatment of the same fractures. The investigators hypothesized that patients undergoing the direct anterior approach would have better clinical and radiological results in comparison with the mini posterior and lateral approach.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Femoral Neck Fractures
Keywords
hip, fractures, surgical approach, outcome, bleeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Direct anterior approach
Arm Type
Active Comparator
Arm Description
Patients with a femoral neck fracture, treated by hemiarthroplasty by direct anterior approach, using a regular OR table, without hip hyperextension.
Arm Title
Mini Posterior Approach
Arm Type
Active Comparator
Arm Description
Patients with a femoral neck fracture, treated by hemiarthroplasty by a mini posterior approach.
Arm Title
Lateral approach
Arm Type
Active Comparator
Arm Description
Patients with a femoral neck fracture, treated by hemiarthroplasty by a lateral (Hardinge) approach.
Intervention Type
Procedure
Intervention Name(s)
Direct Anterior Approach Hemiarthroplasty
Intervention Description
Hemiarthroplasty to elderly patients with femoral neck fracture through a direct anterior approach
Intervention Type
Procedure
Intervention Name(s)
Mini Posterior Approach
Intervention Description
Hemiarthroplasty to elderly patients with femoral neck fracture through a mini posterior approach
Intervention Type
Procedure
Intervention Name(s)
Lateral approach
Intervention Description
Hemiarthroplasty to elderly patients with femoral neck fracture through a lateral approach (Hardinge)
Primary Outcome Measure Information:
Title
The Five Item Barthel Index
Description
Patient mobilization and motoric status measured with a five-item-Barthel index.
The Barthel scale is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. The Barthel Index is a widely used measure of physical dependence in personal activities of daily living (PADL). The short five-item Barthel index score ranges from 0-15 points, with 0 means the worst score and 15 the optimal score that a patient can achieve.
Time Frame
6 weeks post-surgery
Title
The Five Item Barthel Index
Description
Patient mobilization and motoric status measured with a five-item-Barthel index.
The Barthel scale is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. The Barthel Index is a widely used measure of physical dependence in personal activities of daily living (PADL). The short five-item Barthel index score ranges from 0-15 points, with 0 means the worst score and 15 the optimal score that a patient can achieve.
Time Frame
3 months post-surgery
Title
The Timed Up and Go test (TUG)
Description
The Timed Up and Go test, is a test of balance that is commonly used to examine functional mobility in community-dwelling, frail older adults. The test requires a subject to stand up, walk 3 m (10 ft), turn, walk back, and sit down. Time taken to complete the test is strongly correlated to the level of functional mobility.
Older adults who are able to complete the task in less than 20 seconds have been shown to be independent in transfer tasks involved in activities of daily living, and walk at gait speeds that should be sufficient for community mobility (0.5 m/s). In contrast, older adults requiring 30 seconds or longer to complete the task tend to be more dependent on activities of daily living and require assistive devices for ambulation.
Time Frame
4 days after the surgery
Title
The Timed Up and Go test (TUG)
Description
The Timed Up and Go test, is a test of balance that is commonly used to examine functional mobility in community-dwelling, frail older adults. The test requires a subject to stand up, walk 3 m (10 ft), turn, walk back, and sit down. Time taken to complete the test is strongly correlated to the level of functional mobility.
Older adults who are able to complete the task in less than 20 seconds have been shown to be independent in transfer tasks involved in activities of daily living, and walk at gait speeds that should be sufficient for community mobility (0.5 m/s). In contrast, older adults requiring 30 seconds or longer to complete the task tend to be more dependent on activities of daily living and require assistive devices for ambulation.
Time Frame
6 weeks post surgery
Title
Parker mobility score
Description
Postoperative mobility score, as proposed by Parker and Palmer (Parker MJ, Palmer CR, JBJS Br (1993) ).
The Parker Mobility Score is a composite measurement of the patient's mobility indoors, outdoors and during shopping, and is used in studies either to measure the mobility as an outcome measure or as a predictor for mortality
Range 0-9 points (0 is the worst score and 9 the best score that a patient can achieve)
Time Frame
One week before the fracture occur
Title
Parker mobility score
Description
Postoperative mobility score, as proposed by Parker and Palmer (Parker MJ, Palmer CR, JBJS Br (1993) ).
The Parker Mobility Score is a composite measurement of the patient's mobility indoors, outdoors and during shopping, and is used in studies either to measure the mobility as an outcome measure or as a predictor for mortality
Range 0-9 points (0 is the worst score and 9 the best score that a patient can achieve)
Time Frame
3 months post surgery
Secondary Outcome Measure Information:
Title
Change to the Total blood loss (TBL)
Description
For calculation of the total blood loss (TBL) expressed to total Hb loss and total Volume loss , we will use the number of transfusions (55 grams of haemoglobin per transfusion), the haemoglobin concentration on preoperatively (Hgbi) and the haemoglobin concentration on the last available measure of haemoglobin concentration (Hgbe). (Hemoglobin balance method)
Time Frame
Preop to day 4 post surgery
Title
Change at the Pain Visual Analog (VAS) score
Description
The pain visual analog scale (VAS) is commonly used as the outcome measure for pain. It is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" (0 pain) and "worst pain imaginable." (100 pain)
Time Frame
From day one up to 6 weeks post surgery
Title
Muscle Damage Markers
Description
CK (Creatine Kinase), ECR and CRP
Time Frame
Daily for days 1-4 Post-op
Title
Change at Creatine Kinase (CK)
Description
The appearance of creatine kinase (CK) in blood has been generally considered to be an indirect marker of muscle damage.
Reference Values Males >3 months: 39-308 U/L Females >3 months: 26-192 U/L
Time Frame
Daily for days 1-4 Post-op and at 6 weeks post-op
Title
Change at C-Reactive protein (CRP)
Description
C-reactive protein (CRP) levels have been documented as a potent marker for skeletal muscle damage.
Reference Value: 0-10mg/L
Time Frame
Daily for days 1-4 Post-op and at 6 weeks post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Consecutive patients undergoing hip fracture surgery for displaced femoral neck fractures (Garden 3 and 4 fractures) and treated by cemented hemiarthroplasty will be included in the study. Patients must have the ability to give informed consent or a legal guardian is available.
Exclusion Criteria:
The exclusion criteria include open or pathological fractures, re-fractures, infection, concomitant injuries of the ipsi- or contralateral leg or upper limb, skin diseases in the area of proposed incisions, patients that are mentally incapable of understanding the consequences of the study and reduced compliance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vasileios S Nikolaou, MD, PhD, MSc
Phone
+306932543400
Email
vassilios.nikolaou@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Direct Anterior Approach Versus Mini Posterior Approach Versous Lateral Approach for Displaced Femoral Neck Fractures
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