Dual Mobility Cup Versus Unipolar Cup

NCT04685239 | Not Yet Recruiting DMC

• 1 other identifier: N-20190040
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Dislocation, Hip

Keywords

dislocation, hip; thr; dual mobility cup

Outcome Measures

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.

  1 year after surgery

Secondary Outcomes (6)

• Difference in dislocation within 5 years

  5 years after surgery

• Dislocation 10 year

  10 years after surgery

• Prosthesis survival.

  1, 5 and 10 year

• Patient reported outcome measure: European quality of life 5 dimensions (EQ-5D 5L)

  1, 5 and 10 years

• Patient reported outcome measure: Oxford Hip Score (OHS)

  1, 5 and 10 years

Study Arms (2)

Unipolar cup

ACTIVE COMPARATOR

Patients randomized to receive a conventional unipolar acetabular cup

Device: unipolar cup

dual mobility cup

ACTIVE COMPARATOR

Patients randomized to receive a double mobility acetabular cup

Device: dual mobility cup

Interventions

dual mobility cup DEVICE

The use of a Sunfit dual mobility cup

dual mobility cup

unipolar cup DEVICE

The use of a TMT cup

Unipolar cup

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northern Orthopaedic Division, Denmark: lead

Study Sites (1)

Aalborg University Hospital

Aalborg, Northen Denmark, 9000, Denmark

Location

MeSH Terms

Conditions

Hip Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries

Central Study Contacts

Anders Diernæs, MD

CONTACT

+4597662503; anders.diernaes@rn.dk

Thomas Jakobsen, MD, PhD

CONTACT

thomas.jakobsen@rn.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: controlled randomized trial

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 28, 2020
• Study Start: April 1, 2023
• Primary Completion: January 1, 2025
• Study Completion (Estimated): December 1, 2035
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)