Optimized Treatment
Conditions
Keywords
Hip-fracture, RSA
Brief summary
This is a Randomized Controlled Trial study comparing hemialloplastik versus total joint replacement.
Detailed description
Seventy patients over seventy years who are admitted in our hip fracture department with the indication for hemi joint replacement therapy, due to a Garden 3-4 femoral neck fracture or a fracture Garden 1-2 with over 20-degree posterior tilt are randomized to either hemialloplastik or total joint replacement. The patients are followed for 24 mouths with X-ray Stereo Photogrammetric Analysis (RSA) radiographs and clinical examinations.
Interventions
PROCEDUREHemi (hemialloplastik)
THA vs hemi
Sponsors
Hvidovre University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over 70 years, admitted two our hip-fracture department with a 3-4 Garden femoral neck fracture or a fracture Garden 1-2 with over 20-degree posterior tilt. * Preoperative New Mobility Score ≥ 6th * Patients must be able to speak and understand Danish. * Patients must be able to give informed consent and be cognitively intact (Hindsøe score ≥ 6). * Patients should be expected to be able to implement the postoperative controls. Patients should not be medically ill: ASA-score ≤ 3rd
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic and clinical | Five years | Migration / rotation: Migration is measured by X-ray Stereo Photogrammetric Analysis (RSA). Clinical assessment: The patient is assessed clinically using the WOMAC and EQ-5D. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical | Five years | Implant Placement: Mobilisation: Patient mobilization level before the fracture is assessed by the New Mobility Score.Under hospital assessed patients' ability to time with current time instrument daily using the Cumulated ambulation score (CAS). Bleeding: Perioperative bleeding set in operation description from start to suture the incision closed. Hgb is measured as standard on the third day in all patients in the hip fracture unit. In addition, registered the need for blood transfusions in the first four postoperative days. |
Countries
Denmark
Outcome results
None listed