Hip FracturesNCT04618549
Direct Anterior Approach Versus Mini Posterior Approach Versous Lateral Approach for Displaced Femoral Neck Fractures
A study testing Direct Anterior Approach Hemiarthroplasty, Mini Posterior Approach and Lateral approach in people with Hip Fractures and Femoral Neck Fractures, run by National and Kapodistrian University of Athens.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures, Femoral Neck Fractures
- What is being tested?
- Direct Anterior Approach Hemiarthroplasty, Mini Posterior Approach and Lateral approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 30 Mar 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Conditions
- Hip Fractures, Femoral Neck Fractures
- Being tested
- Direct Anterior Approach Hemiarthroplasty, Mini Posterior Approach, Lateral approach
- Keywords
- hip, fractures, surgical approach, outcome, bleeding
- Medical subject headings
- Hip Fractures, Femoral Neck Fractures, Fractures, Bone, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Anterior Approach HemiarthroplastyProcedure or surgery
Hemiarthroplasty to elderly patients with femoral neck fracture through a direct anterior approach
Mini Posterior ApproachProcedure or surgery
Hemiarthroplasty to elderly patients with femoral neck fracture through a mini posterior approach
Lateral approachProcedure or surgery
Hemiarthroplasty to elderly patients with femoral neck fracture through a lateral approach (Hardinge)
| Study group | Role | What they receive |
|---|---|---|
| Direct anterior approach | Active comparator | Patients with a femoral neck fracture, treated by hemiarthroplasty by direct anterior approach, using a regular OR table, without hip hyperextension. Receives: Procedure: Direct Anterior Approach Hemiarthroplasty |
| Mini Posterior Approach | Active comparator | Patients with a femoral neck fracture, treated by hemiarthroplasty by a mini posterior approach. Receives: Procedure: Mini Posterior Approach |
| Lateral approach | Active comparator | Patients with a femoral neck fracture, treated by hemiarthroplasty by a lateral (Hardinge) approach. Receives: Procedure: Lateral approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks post-surgery
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.
Measured: 3 months post-surgery
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.
Measured: 4 days after the surgery
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.
Measured: 6 weeks post surgery
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)
Measured: One week before the fracture occur
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)
Measured: 3 months post surgery
Secondary outcomes (5)
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)
Measured: Preop to day 4 post surgery
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)
Measured: From day one up to 6 weeks post surgery
Muscle Damage Markers
CK (Creatine Kinase), ECR and CRP
Measured: Daily for days 1-4 Post-op
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
Measured: Daily for days 1-4 Post-op and at 6 weeks post-op
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
Measured: Daily for days 1-4 Post-op and at 6 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Nov 2020 (estimated)
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Mar 2022 (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 National and Kapodistrian University of AthensThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vasileios S. Nikolaou, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618549
- Sponsor's protocol ID
- 5
- Status last verified
- Oct 2020
- First submitted
- 17 Jun 2020
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04618549
- Acronym / sponsor ID
- 5
- Conditions
- Hip Fractures, Femoral Neck Fractures
- Keywords
- hip, fractures, surgical approach, outcome, bleeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 6 Nov 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Direct anterior approach | Active comparator | Procedure: Direct Anterior Approach HemiarthroplastyPatients with a femoral neck fracture, treated by hemiarthroplasty by direct anterior approach, using a regular OR table, without hip hyperextension. |
| Mini Posterior Approach | Active comparator | Procedure: Mini Posterior ApproachPatients with a femoral neck fracture, treated by hemiarthroplasty by a mini posterior approach. |
| Lateral approach | Active comparator | Procedure: Lateral approachPatients with a femoral neck fracture, treated by hemiarthroplasty by a lateral (Hardinge) approach. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Direct Anterior Approach HemiarthroplastyHemiarthroplasty to elderly patients with femoral neck fracture through a direct anterior approach | Procedure or surgery | Direct anterior approach |
| Mini Posterior ApproachHemiarthroplasty to elderly patients with femoral neck fracture through a mini posterior approach | Procedure or surgery | Mini Posterior Approach |
| Lateral approachHemiarthroplasty to elderly patients with femoral neck fracture through a lateral approach (Hardinge) | Procedure or surgery | Lateral approach |
Primary outcome
The Five Item Barthel Index
Time frame: 6 weeks post-surgery
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
Time frame: 3 months post-surgery
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)
Time frame: 4 days after the surgery
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)
Time frame: 6 weeks post surgery
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
Time frame: One week before the fracture occur
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
Time frame: 3 months post surgery
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)
5 secondary outcomes
Change to the Total blood loss (TBL)
Time frame: Preop to day 4 post surgery
Change at the Pain Visual Analog (VAS) score
Time frame: From day one up to 6 weeks post surgery
Muscle Damage Markers
Time frame: Daily for days 1-4 Post-op
Change at Creatine Kinase (CK)
Time frame: Daily for days 1-4 Post-op and at 6 weeks post-op
Change at C-Reactive protein (CRP)
Time frame: Daily for days 1-4 Post-op and at 6 weeks post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Anterior Approach Hemiarthroplasty, Mini Posterior Approach and Lateral approach in people with Hip Fractures and Femoral Neck Fractures, run by National and Kapodistrian University of Athens.
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 1 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 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Vasileios S Nikolaou, MD, PhD, MSc (+306932543400, vassilios.nikolaou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Five Item Barthel Index (time frame: 6 weeks post-surgery). The study lists 6 primary outcomes in all. 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 Nov 2020.