NCT04031820

Brief Summary

Objective: The primary objective is to investigate whether there is a difference in the number of hip dislocations following primary total hip arthroplasty (THA), using the posterolateral approach, with a DM cup compared to a unipolar cup in elderly patients 1 year after surgery. Study design: Prospective multi-center nation wide, single blinded RCT nested in the LROI. Study population: Patients ≥ 70 years old, undergoing an elective primary cemented THA.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Jan 2019May 2027

Study Start

First participant enrolled

January 1, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2019

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 24, 2019

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Expected
Last Updated

February 28, 2025

Status Verified

February 1, 2025

Enrollment Period

7.3 years

First QC Date

January 10, 2019

Last Update Submit

February 25, 2025

Conditions

Total Hip ArthroplastyOsteoarthritis, Hip

Keywords

Primary total hip arthroplastyDual Mobility cup

Outcome Measures

Primary Outcomes (1)

  • Number of dislocations

    The total number of dislocations, regardless of type of treatment (i.e. closed repositioning or revision).

    1 year postoperative

Secondary Outcomes (7)

  • Number of revision surgeries

    1 year postoperative

  • cost-effectiveness questionnaire

    1 year postoperative

  • Number of dislocations

    2 years postoperative

  • Patient Reported Outcomes on physical functioning

    1 and 2 years postoperative

  • Patient Reported Outcomes on pain

    1 and 2 years postoperative

  • +2 more secondary outcomes

Study Arms (2)

unipolar cup

ACTIVE COMPARATOR

550 patients will receive a total hip arthroplasty with a unipolar cup.

Procedure: Unipolar cup

Dual Mobility cup

ACTIVE COMPARATOR

550 patients will receive a total hip arthroplasty with a dual mobility cup.

Procedure: Dual mobility cup

Interventions

Unipolar cupPROCEDURE

Cemented unipolar acetabulum cup for primary THA

unipolar cup
Dual mobility cupPROCEDURE

Cemented dual mobility acetabulum cup for primary THA

Dual Mobility cup

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients who are eligible for elective primary THA with a cemented cup, with a 32mm or 36 mm liner, for any indication.
  • THA using posterolateral surgical approach.
  • Patients ≥ 70 years old
  • Adequate comprehension of written and spoken Dutch

You may not qualify if:

  • Patients unable to complete PROMs
  • Patients with dementia, epilepsy\*, spasticity\*, mental retardation or alcoholism. (If dementia or mental retardation is not already mentioned in the medical chart, this can be determined by doctors opinion.)
  • Patients not eligible for either a unipolar or a DM cup
  • These patients will be asked to participate in the non-randomized dual mobility observational cohort.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OLVG

Amsterdam, 1091 AC, Netherlands

RECRUITING

Related Publications (1)

  • Van Beers LWAH, Van Der Wal BCH, Van Loon TG, Moojen DJF, Van Wier MF, Klaassen AD, Willigenburg NW, Poolman RW; Collaborator group. Study protocol: Effectiveness of dual-mobility cups compared with uni-polar cups for preventing dislocation after primary total hip arthroplasty in elderly patients - design of a randomized controlled trial nested in the Dutch Arthroplasty Registry. Acta Orthop. 2020 Oct;91(5):514-519. doi: 10.1080/17453674.2020.1798658. Epub 2020 Aug 4.

    PMID: 32746668DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Rudolf Poolman, MD, PhD

    OLVG, Amsterdam, the Netherlands

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Loes van Beers, MSc

CONTACT

+31205993653l.w.a.h.vanbeers@olvg.nl

Nienke Willigenburg, PhD

CONTACT

+31205992415n.w.willigenburg@olvg.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2019

First Posted

July 24, 2019

Study Start

January 1, 2019

Primary Completion

May 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

February 28, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)