Bone Mineral Density, Femoral Neck Fractures, Muscle Damage, Surgical Approach
Conditions
Brief summary
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
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.
Interventions
PROCEDUREPosterior SPAIRE approach, anterior approach
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)
Sponsors
Sorlandet Hospital HF
South-Eastern Norway Regional Health Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Outcome assessors are blinded to allocation by not having access to patients study protocol and by examining patients covering their operated hip with clothing. Patients are attempted blinded by using wound dressings to cover their operated hip and are, unless expressing specific interest in knowing the surgical approach, not informed of the randomization result. To evaluate the blinding of patients we will record their knowledge of which surgical approach they were operated with at their 12-month follow-up.
Intervention model description
Patients are allocated to either an anterior approach or a posterior approach after inclusion. Both groups are operated with a cemented hemiarthroplasty
Eligibility
Sex/Gender
ALL
Age
70 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score | 2 years | The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent patient reported outcome measured by Harris Hip Score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone Mineral Density | 2 years | 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). |
| Muscle damage | 2 years | 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) |
| Health-related quality of life (HRQoL) | 2 years | 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 |
| Radiographic stem positioning | 2 years | The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent radiographic stem positioning. |
Countries
Norway
Contacts
STUDY_DIRECTORLars Nordsletten, MD,PhD,Professor
Oslo University Hospital
Outcome results
None listed