Clinical trial NCT04618549: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Fractures
Femoral Neck Fractures
Keywords: hip
fractures
surgical approach
outcome
bleeding
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The Five Item Barthel Index
timeFrame: 6 weeks post-surgery
measure: The Five Item Barthel Index
timeFrame: 3 months post-surgery
measure: The Timed Up and Go test (TUG)
timeFrame: 4 days after the surgery
measure: The Timed Up and Go test (TUG)
timeFrame: 6 weeks post surgery
measure: Parker mobility score
timeFrame: One week before the fracture occur
measure: Parker mobility score
timeFrame: 3 months post surgery
Secondary outcomes:
measure: Change to the Total blood loss (TBL)
timeFrame: Preop to day 4 post surgery
measure: Change at the Pain Visual Analog (VAS) score
timeFrame: From day one up to 6 weeks post surgery
measure: Muscle Damage Markers
timeFrame: Daily for days 1-4 Post-op
measure: Change at Creatine Kinase (CK)
timeFrame: Daily for days 1-4 Post-op and at 6 weeks post-op
measure: Change at C-Reactive protein (CRP)
timeFrame: Daily for days 1-4 Post-op and at 6 weeks post-op
Other outcomes:
Locations:
Study officials:
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