Femoral Neck Fractures Clinical Trial
Official title:
Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach: A Follow-up of a Randomized Controlled Trial.
Verified date | May 2019 |
Source | Sorlandet Hospital HF |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach. Comparing leg length discrepancy, femoral offset, valgus/varus position of the stem. Also is there a difference in heterotopic ossification at 12 months.
Status | Completed |
Enrollment | 150 |
Est. completion date | July 31, 2018 |
Est. primary completion date | July 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years to 90 Years |
Eligibility | Inclusion Criteria: - Patients between 70 and 90 years of age with displaced femoral neck fractures - Intact cognitive function - Ability to walk with or without a walking aid prior to falling. Exclusion Criteria: - Dementia - Fractures in pathologic bone - Patients not belonging to the hospital community - Patients with sepsis or local infection - Fracture not eligible to be treated with a hemiarthroplasty |
Country | Name | City | State |
---|---|---|---|
Norway | Sorlandet Hospital | Kristiansand |
Lead Sponsor | Collaborator |
---|---|
Sorlandet Hospital HF |
Norway,
Ugland TO, Haugeberg G, Svenningsen S, Ugland SH, Berg ØH, Hugo Pripp A, Nordsletten L. Less periprosthetic bone loss following the anterolateral approach to the hip compared with the direct lateral approach. Acta Orthop. 2018 Feb;89(1):23-28. doi: 10.1080/17453674.2017.1387730. Epub 2017 Oct 17. — View Citation
Ugland TO, Haugeberg G, Svenningsen S, Ugland SH, Berg ØH, Pripp AH, Nordsletten L. Biomarkers of muscle damage increased in anterolateral compared to direct lateral approach to the hip in hemiarthroplasty: no correlation with clinical outcome : Short-term analysis of secondary outcomes from a randomized clinical trial in patients with a displaced femoral neck fracture. Osteoporos Int. 2018 Aug;29(8):1853-1860. doi: 10.1007/s00198-018-4557-y. Epub 2018 May 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Canal Flare index | the ratio of the intracortical width of the femur at 20 mm proximal to the tip of lesser trochanter and isthmus at 10 cm distally | Immediately after surgery | |
Other | Dorr classification | Morphology of the proximal femur | Immediately after surgery | |
Other | Cortical Thickness Index | the ratio of cortical width minus endosteal width, to cortical width at 10 cm below the tip of lesser trochanter | Immediately after surgery | |
Primary | Leg length | The perpendicular distance between a horizontal line passing through the lower edge of the teardrop to the ipsilateral center of the femoral head | Immediately after surgery | |
Secondary | Femoral offset | The distance between the longitudinal axis of the femur to the centre of the femoral head and the distance from the centre of the femoral head to a perpendicular line passing through the medial edge of the teardrop | Immediately after surgery | |
Secondary | Valgus/varus stem position | Stem position in relation to the femoral axis | Immediately after surgery | |
Secondary | Heterotopic ossification | Classified as type 1-4 according to Brooker classification | 1 year | |
Secondary | Canal fill ratio | Was evaluated at the following points; 2 cm above the lower trochanter, at the tip of the lower trochanter, 2 cm and 7 cm below the tip of lesser trochanter | Immediately after surgery |
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