Dual Mobility Cup Versus Unipolar Cup

NCT04685239 · tracked via the Priya Life Science Denmark tracker

Sponsor

Northern Orthopaedic Division, Denmark

Phase

Not applicable

Started

2023-04-01

Last updated

2023-03-27

Condition(s) studied

Dislocation, Hip

Investigational drug(s) / intervention(s)

dual mobility cupunipolar cup

dual mobility cup: The use of a Sunfit dual mobility cup

unipolar cup: The use of a TMT cup

Study 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).

Eligibility

Sex

ALL

Min age

65 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Early dislocation, Difference in dislocation within 1 year. — 1 year after surgery
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.

Trial sites (1)

Facility	City	Region	Status
Aalborg University Hospital	Aalborg	Northen Denmark

More Northern Orthopaedic Division, Denmark trials in Denmark

Selecting the Right Hip Prosthesis for Young Patients Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04685239 on ClinicalTrials.gov ↗ ← All trials in Denmark