Femoral Neck Fractures Clinical Trial
Official title:
Cemented Hemiarthroplasty in Femoral Neck Fractures; Are Clinical Results Affected by Surgical Approach. A Randomized Clinical Trial Comparing Posterior and Anterior Approach
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.
Status | Recruiting |
Enrollment | 210 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Norway | Sorlandet Hospital | Arendal | |
Norway | Sorlandet hospital | Kristiansand |
Lead Sponsor | Collaborator |
---|---|
Sorlandet Hospital HF | South-Eastern Norway Regional Health Authority |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Radiographic stem positioning | The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent radiographic stem positioning. | 2 years |
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