Surgical Approach in Hemiarthroplasty. A Randomized Clinical Trial Comparing Posterior and Anterior Approach

Study Overview
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Brief Summary
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Dislocated femoral neck fractures are routinely treated with cemented hemiartroplasty and the direct lateral approach (Hardinge) has commonly been used in Norway. The investigators have lately witnessed a significant change in the prefered surgical approaches in total hip arthroplasty (THA) in favor of the posterior and anterior approaches. The direct lateral approach has in THA, more or less, been abandoned in Norway. Numerous studies have reported superior results using the posterior and anterior approahes compared to the lateral approach.

Detailed Description
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The investigators have witnessed a marked change in preferred anatomical route to the hip joint when performing total hip artrhroplasty (THA) for osteoarthritis in Norway. The direct lateral approach, which 10 years ago dominated, is today more or less abandoned. Several studies have reported inferior results in patients operated with the lateral approach compared to the posterior and anterior approaches, the latter approaches used in approximately 95 % of all THA´s i Norway. Many approaches are known for hip arthroplasty in trauma patients, but there is little consensus on the preferred method. The preferred surgical approach varies among hospitals and surgeons. Identifying the best possible approach for HA could lead to shorter hospital admission, faster rehabilitation, better functional outcomes, lower morbidity and mortality and improvement in patient independence. Consequently healthcare costs related to a hip fracture could be reduced. As of today the clinical results, reoperation rate and the morbidity have improved significantly in hemiarthroplasty treatment for dislocated femoral neck fractures. However, patients are primarily operated with the lateral approach, although inferior results are reported compared to posterior and anterior approaches. RCT´s from Ugland et al and Mjaaland have shown increased incidence of limping, lateral thigh pain and inferior PROM´s in patients operated with the direct lateral approach compared to patients operated with anterior approaches. A meta-analysis regarding hemiarthroplasty and surgical approaches from 2018 concluded that high-quality comparative studies are needed to further substantiate the preferred anatomic route for hemiarthroplasty in older femoral neck fracture patients.

Official Title
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Cemented Hemiarthroplasty in Femoral Neck Fractures; Are Clinical Results Affected by Surgical Approach. A Randomized Clinical Trial Comparing Posterior and Anterior Approach

Conditions
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Muscle Damage, Femoral Neck Fractures, Bone Mineral Density, Surgical Approach

Intervention / Treatment
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* Procedure: Posterior SPAIRE approach, anterior approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 70 and 90 years of age Displaced FNF Ability to walk with or without a walking aid prior to falling Patients having Sorlandet Hospital as primary service provider for orthopaedic trauma Provision of informed consent by patient or proxy Low energy fracture (fall from standing height, no other major trauma) Exclusion Criteria: Dementia Fractures in pathologic bone Patients not suited for HA (i.e., inflammatory arthritis, severe osteoarthritis) Associated major injuries of the lower extremity ( i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula or femur) Retained hardware around the affected hip that will interfere with arthroplasty Sepsis or local infection

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients are allocated to either an anterior approach or a posterior approach after inclusion. Both groups are operated with a cemented hemiarthroplasty
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: cemented hemiarthroplasty , posterior SPAIRE approach<br>Posterior SPAIRE approach: lateral decubitus position, preservation of the piriformis tendon and obturator internus, detatchment of obturator externus , capsular T-incision, femoral neck resection, femoral canal reaming according to preoperative templating, third generation cementation technique, capsular repair, repair of obturator externus. | Procedure: Posterior SPAIRE approach, anterior approach<br>* Based on power calculation a sub-group analysis of 50 patients will be examined with DXA, all patients for biochemical and clinical muscle damage (CK, CRP, TUG-test, Trendelenburg, strenght test)<br>* Other names: Clinical muscle damage;|
| Active Comparator: cemented hemiarthroplasty, anterior approach<br>Anterior approach: supine position, both legs washed and draped, intermuscular plane between m. tensor fascia lata and m. sartorius, capsular T-incision, femoral neck resection, femoral canal reaming according to preoperative templating, third generation cementation technique, capsular repair | Procedure: Posterior SPAIRE approach, anterior approach<br>* Based on power calculation a sub-group analysis of 50 patients will be examined with DXA, all patients for biochemical and clinical muscle damage (CK, CRP, TUG-test, Trendelenburg, strenght test)<br>* Other names: Clinical muscle damage;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score | The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent patient reported outcome measured by Harris Hip Score. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density | The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent postoperative changes in bone mineral density measured by dual-energy X-ray absorptiometry (DXA). | 2 years | 
| Muscle damage | The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent postoperative changes in biochemical muscle damage measured by Creatin Kinase (CK) | 2 years | 
| Muscle damage | The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent postoperative changes in clinical muscle damage measured by TUG-test | 2 years | 
| Muscle damage | The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent postoperative changes in clinical muscle damage measured by Trendelenburg test | 2 years | 
| Muscle damage | The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent postoperative changes in clinical muscle damage measured by muscle strength | 2 years | 
| Health-related quality of life (HRQoL) | The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent health-related quality of life (HRQoL) measured by HOOS | 2 years | 
| Health-related quality of life (HRQoL) | The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent health-related quality of life (HRQoL) measured by Eq-5d | 2 years | 
| Health-related quality of life (HRQoL) | The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent health-related quality of life (HRQoL) measured by Visual Analog Score (VAS) | 2 years | 
| Radiographic stem positioning | The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent radiographic stem positioning. | 2 years |