Dual Mobility Cup Versus Unipolar Cup
Primary Purpose
Dislocation, Hip
Status
Not yet recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
dual mobility cup
unipolar cup
Sponsored by
About this trial
This is an interventional treatment trial for Dislocation, Hip focused on measuring dislocation, hip, thr, dual mobility cup
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Earlier hip bone surgery (excluding arthroscopic surgery).
- Elective bilateral surgery.
- If the patient's bone morphology is unsuitable for a cemented Exeter® femoral stem.
- Patients with no e-mail.
Sites / Locations
- Aalborg University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Unipolar cup
dual mobility cup
Arm Description
Patients randomized to receive a conventional unipolar acetabular cup
Patients randomized to receive a double mobility acetabular cup
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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).
Full Information
NCT ID
NCT04685239
First Posted
December 15, 2020
Last Updated
March 24, 2023
Sponsor
Northern Orthopaedic Division, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT04685239
Brief Title
Dual Mobility Cup Versus Unipolar Cup
Official Title
Risk of Dislocation After Total Hip Replacement: Dual Mobility Cup vs. Unipolar Cup. A Randomized Controlled Trial With Patients ≥65 Years Operated for Hip Osteoarthritis With Primary Total Hip Replacement (THR).
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
December 2035 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northern Orthopaedic Division, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dislocation, Hip
Keywords
dislocation, hip, thr, dual mobility cup
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
controlled randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Unipolar cup
Arm Type
Active Comparator
Arm Description
Patients randomized to receive a conventional unipolar acetabular cup
Arm Title
dual mobility cup
Arm Type
Active Comparator
Arm Description
Patients randomized to receive a double mobility acetabular cup
Intervention Type
Device
Intervention Name(s)
dual mobility cup
Intervention Description
The use of a Sunfit dual mobility cup
Intervention Type
Device
Intervention Name(s)
unipolar cup
Intervention Description
The use of a TMT cup
Primary Outcome Measure Information:
Title
Early dislocation, Difference in dislocation within 1 year.
Description
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 surgery
Secondary Outcome Measure Information:
Title
Difference in dislocation within 5 years
Description
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 surgery
Title
Dislocation 10 year
Description
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 surgery
Title
Prosthesis survival.
Description
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 year
Title
Patient reported outcome measure: European quality of life 5 dimensions (EQ-5D 5L)
Description
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 years
Title
Patient reported outcome measure: Oxford Hip Score (OHS)
Description
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.
Time Frame
1, 5 and 10 years
Title
Patient reported outcome measures: The Copenhagen Hip and Groin Outcome Score (HAGOS)
Description
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).
Time Frame
1, 5 and 10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Earlier hip bone surgery (excluding arthroscopic surgery).
Elective bilateral surgery.
If the patient's bone morphology is unsuitable for a cemented Exeter® femoral stem.
Patients with no e-mail.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anders Diernæs, MD
Phone
+4597662503
Email
anders.diernaes@rn.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Jakobsen, MD, PhD
Email
thomas.jakobsen@rn.dk
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
State/Province
Northen Denmark
ZIP/Postal Code
9000
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders Diernæs, MD
Phone
+4597662503
Email
anders.diernaes@rn.dk
First Name & Middle Initial & Last Name & Degree
Thomas Jakobsen, MD, PhD
Email
thomas.jakobsen@rn.dk
12. IPD Sharing Statement
Plan to Share IPD
No
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Dual Mobility Cup Versus Unipolar Cup
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