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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).
Surgery with THR for arthritis and other hip disorders has long been one of the most successful orthopedic surgical treatments. The majority of the patients gain pain relief and experience improved hip function. In 2017, a total of 10,691 THRs were implanted in Denmark (annual report 2018).
Hip dislocation is a known complication after THR. It is a painful condition which may have far-reaching consequences for the patient, who may experience both physical and mental discomfort. Ultimately, multiple hip dislocations may result in reoperation.
In the literature, the incidence of hip dislocation is reported at 2-6 %, and a more recent review reports a risk of 0.5-10 %.
In Denmark, recurrent hip dislocation is the cause of 21 % of the reoperations per year according to The Danish Hip Arthroplasty Register. According to the British National Joint Registry (NJR) and the Australian register (AOANJRR), hip dislocation is the cause of 15.5 % and 21 %, respectively, of the reoperations.
The best method to avoid reoperation due to instability is to choose the correct implant for the individual patient and thereby spare the patient of having to endure a painful complication and yet another procedure. There are multiple risk factors for instability after THR, and increased use of dual mobility cups (DMC) is already documented.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unipolar cup | Active Comparator | Patients randomized to receive a conventional unipolar acetabular cup |
|
| dual mobility cup | Active Comparator | Patients randomized to receive a double mobility acetabular cup |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dual mobility cup | Device | The use of a Sunfit dual mobility cup |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anders Diernæs, MD | Contact | +4597662503 | anders.diernaes@rn.dk | |
| Thomas Jakobsen, MD, PhD | Contact | thomas.jakobsen@rn.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | Northen Denmark | 9000 | Denmark |
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| ID | Term |
|---|---|
| D006617 | Hip Dislocation |
| ID | Term |
|---|---|
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
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controlled randomized trial
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| unipolar cup |
| Device |
The use of a TMT cup |
|
| 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. | 10 years after surgery |
| 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. | 1, 5 and 10 year |
| 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. | 1, 5 and 10 years |
| Patient reported outcome measure: Oxford Hip Score (OHS) | Patients will be scored with OHS at baseline and at 1, 5 and 10 years. OHS is a patient-recorded outcome measure designed to assess the outcome of hip replacements. Its a score between 0-48 with 48 being the best. | 1, 5 and 10 years |
| Patient reported outcome measures: The Copenhagen Hip and Groin Outcome Score (HAGOS) | HAGOS pain subscale will be used to report pain pre and postoperatively. The score in the pain subscale ranges from 0 (extreme hip/groin problems) -100 (no hip/groin problems). | 1, 5 and 10 years |
| D025981 |
| Hip Injuries |