Femoral Neck Fractures, Hemiarthroplasty, Heterotopic Ossification
Conditions
Keywords
femoral offset, leg length discrepancy, valgus/varus position, Lateral approach, Anterolateral approach
Brief summary
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.
Detailed description
Between January 2014 and July 2017 a RCT was conducted at Sorlandet Hospital Kristiansand, Norway. The trial was approved by the regional ethics committee (2013/1853/REK) and registered at ClinicalTrials.gov (ClinicalTrials.gov Identifier NCT02028468). This study is a follow-up on the same study population. 150 patients (70 to 90 years) with a displaced femoral neck fracture was randomized to be operated With either anterolateral og Direct lateral surgical approach. Investigators want to compare the radiological features of the femoral stem between the two Groups.
Interventions
PROCEDUREHemiarthroplasty
Radiological features comparing the femoral stem position is measured on the postoperative x-ray. Presence of heterotopic ossification is assessed on the 12 months follow up.
Sponsors
Sorlandet Hospital HF
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants attempted masked.
Eligibility
Sex/Gender
ALL
Age
70 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leg length | Immediately after surgery | The perpendicular distance between a horizontal line passing through the lower edge of the teardrop to the ipsilateral center of the femoral head |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Valgus/varus stem position | Immediately after surgery | Stem position in relation to the femoral axis |
| Femoral offset | Immediately after surgery | 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 |
| Heterotopic ossification | 1 year | Classified as type 1-4 according to Brooker classification |
| Canal fill ratio | Immediately after surgery | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cortical Thickness Index | Immediately after surgery | the ratio of cortical width minus endosteal width, to cortical width at 10 cm below the tip of lesser trochanter |
| Dorr classification | Immediately after surgery | Morphology of the proximal femur |
| Canal Flare index | Immediately after surgery | 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 |
Countries
Norway
Outcome results
None listed