Dual Mobility Cup Versus Unipolar Cup
ConditionDislocation, Hip
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorNorthern Orthopaedic Division, Denmark
About this trial
The general purpose of this study is to examine whether the dual mobility cup (Novae® Serf) reduces the number of hip dislocations after total hip replacement, both early dislocation (≤1 year) and late dislocation (\>1 year) after primary THR compared with a conventional cup design (Trabecular MetalTM Modular Acetabular System).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with hip arthritis who are amenable to surgery with THR and age ≥ 65 years referred to the Department of Orthopedic Surgery at either Section Farsø, Frederikshavn Hospital or Aalborg University Hospital. Patients who are willing to participate in the trial and who give their written, informed consent after receiving oral and written information.
Disqualifiers
Patients who do not wish to participate.
Sequelae of Calvé-Legg-Perthes' disease, caput necrosis, epiphysiolysis.
Proximal femoral or acetabular fracture.
Hip dysplasia with subluxation Crowe types III and IV.
Trial design
Design model
Single group
Treatments tested in this trial
dual mobility cup
DeviceThe use of a Sunfit dual mobility cup
unipolar cup
DeviceThe use of a TMT cup
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Unipolar cupActive comparator 1 intervention
Group B: dual mobility cupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Early dislocation, Difference in dislocation within 1 year.
The primary outcome is the difference in cumulative incidence proportion of dislocation between the 2 randomized groups within the first year after total hip replacement. The information will be collected from both the patient through questionnaires and from the Danish Hip Arthroplasty Register and the Danish National Patient Register.
Time frame
1 year after surgerySecondary outcomes
1
Difference in dislocation within 5 years
The difference in cumulative incidence proportion of dislocation between the 2 randomized groups within 5 years after total hip replacement. The information will be collected from both the patient through questionnaires and from the Danish Hip Arthroplasty Register and the Danish National Patient Register.
Time frame
5 years after surgery2
Dislocation 10 year
The difference in cumulative incidence proportion of dislocation between the 2 randomized groups within 10 years after total hip replacement. The information will be collected from both the patient through questionnaires and from the Danish Hip Arthroplasty Register and the Danish National Patient Register.
Time frame
10 years after surgery3
Prosthesis survival.
Evaluated by the cumulative incidence of THR's reoperated within 1, 5 and 10 years after total hip replacement. The information will be collected from both the patient through questionnaires and from the Danish Hip Arthroplasty Register and the Danish National Patient Register.
Time frame
1, 5 and 10 year4
Patient reported outcome measure: European quality of life 5 dimensions (EQ-5D 5L)
Patients will be scored with EQ-5D 5L preoperatively and at 1,5 and 10 years. It consists of 5 dimensions ranging from 1-5, with 1 being the best in each dimension. It also consist of a visual analog scale ranging from 0-100, 100 being the best imaginable health, The EQ VAS describes the respondents current overall health. Data will be showed as changes in health over time showing responses at baseline and at follow up or as frequencies and proportions reported by dimension and level.
Time frame
1, 5 and 10 yearsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: