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Effectiveness of dual-mobility cups for preventing dislocation after primary total hip arthroplasty by a posterolateral approach and their cost-effectiveness compared to unipolar cups in elderly patients.

Effectiveness of dual-mobility cups for preventing dislocation after primary total hip arthroplasty by a posterolateral approach and their cost-effectiveness compared to unipolar cups in elderly patients. - REDEP

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54641
Enrollment
1000
Registered
2018-02-06
Start date
2019-04-23
Completion date
Unknown
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total hip replacement

Interventions

The intervention group receives a THA with a dual mobility cup, the control group receives a THA with a unipolar cup.

Sponsors

OLVG
Lead Sponsor

Eligibility

Age
65 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients who are eligible for elective primary THA with a cemented cup, with a 32mm or 36mm femoral head, for any indication - Patients aged >= 70 - Using posterolateral surgical approach. - Adequate comprehension of written and spoken Dutch

Exclusion criteria

Exclusion criteria: - Patients unable to complete PROMs - Patients with dementia, epilepsy*, spasticity*, mental retardation or alcoholism. - Patients not eligible for either a unipolar or a DM cup, * these patients will be asked to participate in the non-randomized dual mobility cohort.

Design outcomes

Primary

MeasureTime frame
The number of dislocations, disregarding type of treatment (i.e. closed repositioning or revision).

Secondary

MeasureTime frame
- Revision surgery of any component - Patient Reported Outcome Measures (PROMs) Standard following guidelines of the Dutch orthopaedic association (NOV. Follow-up pre- operative, 3 months and 1 year postoperative. Additional for this study: 2 years postoperative. o HOOS-PS o EQ-5D o NRS-pain rest/weight bearing o Anchor question about change in functioning Added as extra question to the standard PROMs: o Fear of hip dislocation on a 5 point Likert scale * Added at all follow-up moments o Healthcare and societal costs related to hip dislocation or surgery. * Added at 3 months and 1 year postoperative.

Countries

Netherlands, Spain

Contacts

Public ContactE Scheijbeler

OLVG

E.Scheijbeler@olvg.nl0205993653

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)