Dual Mobility Cup Versus Unipolar Cup

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).

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Dislocation, Hip
• Intervention / Treatment: Device: unipolar cup; Device: dual mobility cup

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anders Diernæs, MD; Phone Number: +4597662503; Email: anders.diernaes@rn.dk
• Study Contact Backup: Name: Thomas Jakobsen, MD, PhD; Email: thomas.jakobsen@rn.dk

Study Locations

• Denmark
  • Northen Denmark
    • Aalborg, Northen Denmark, Denmark, 9000
      • Aalborg University Hospital
      • Contact: Anders Diernæs, MD; Phone Number: +4597662503; Email: anders.diernaes@rn.dk
      • Contact: Thomas Jakobsen, MD, PhD; Email: thomas.jakobsen@rn.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Unipolar cup; Patients randomized to receive a conventional unipolar acetabular cup	Device: unipolar cup; The use of a TMT cup
Active Comparator: dual mobility cup; Patients randomized to receive a double mobility acetabular cup	Device: dual mobility cup; The use of a Sunfit dual mobility cup

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Northern Orthopaedic Division, Denmark

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): December 1, 2035

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: dislocation, hip; thr; dual mobility cup
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Hip Injuries; Hip Dislocation; Joint Dislocations
• Other Study ID Numbers: N-20190040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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