None listed
Conditions
Brief summary
The choice between unipolar and bipolar hemiarthroplasty in displaced intracapsular fractures in elderly still remains controversial. Bipolar head has been postulated to decrease the wear of acetabulum thereby diminishing the risk of conversion to total arthroplasty with time. Our objective was to compare series of elderly individuals who sustained a displaced femoral neck fracture treated with either a cemented, modular monopolar prosthesis or a cemented, modular bipolar prosthesis with the same femoral component for at least five years.
Interventions
The difference between unipolar versus bipolar head (Lubinus, Waldemar Link, Hamburg, Germany) in the same stem (Lubinus SPII, Waldemar Link, Hamburg, Germany) when treating femoral neck fractures in elderly patients. This randomized control study wants to investigate whether there is difference in the outcome of mobility or difference in the acetabular erosion leading to revision surgery. Patients with femoral neck fracture will receive a hemiendoprosthesis either with unipolar or bipolar head,
The difference between unipolar versus bipolar head (Lubinus, Waldemar Link, Hamburg, Germany) in the same stem (Lubinus SPII, Waldemar Link, Hamburg, Germany) when treating femoral neck fractures in elderly patients. This randomized control study wants to investigate whether there is difference in the outcome of mobility or difference in the acetabular erosion leading to revision surgery. Patients with femoral neck fracture will receive a hemiendoprosthesis either with unipolar or bipolar head, 80 minutes surgery time. Primary outcome is revision surgery of any reason, follow-up time is in the minimun 5-years. Survival analyses were performed using Cox regression models. Revision surgery of any reason and complications are stated when occurred and final check-up is done at the end of the study at 30.3.2013.
Sponsors
Tampere University Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Elderly patients over 65 years, displaced femoral neck fracture
Exclusion criteria
Exclusion criteria were (a) age less than sixty five years, (b) fracture of pathological origin (c) non-displaced (Garden I-II) fracture if assumed that patient can follow postoperative weight bearing limitations of internal fixation, (d) alcohol or drug abuse (e) cognitively unintact, (f) known bone diseases or known malignancy, (g) high energy trauma (h) rheumatoid arthritis, (i) osteoarthritis
Outcome results
None listed