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
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 90
- Primary Endpoint
- The Five Item Barthel Index
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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: 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: 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)
Secondary Outcomes
- Change to the Total blood loss (TBL)(Preop to day 4 post surgery)
- Change at the Pain Visual Analog (VAS) score(From day one up to 6 weeks post surgery)
- Muscle Damage Markers(Daily for days 1-4 Post-op)
- Change at Creatine Kinase (CK)(Daily for days 1-4 Post-op and at 6 weeks post-op)
- Change at C-Reactive protein (CRP)(Daily for days 1-4 Post-op and at 6 weeks post-op)
Investigators
Vasileios S. Nikolaou
Associate Professor of Orthopaedics
National and Kapodistrian University of Athens