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Dual-mobility Cups Compared to Unipolar Cups on Dislocation and Cost-effectiveness After Primary Total Hip Arthroplasty.

ConditionsTotal Hip ArthroplastyOsteoarthritis, Hip
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorJointResearch

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Unipolar cup

    Procedure/Surgery

    Cemented unipolar acetabulum cup for primary THA

  • Dual mobility cup

    Procedure/Surgery

    Cemented dual mobility acetabulum cup for primary THA

Treatment groups

1,100 Participants
are divided into 2 treatment groups
Group A: unipolar cupActive comparator 1 intervention
Group B: Dual Mobility cupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of dislocations

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

Time frame
1 year postoperative

Secondary outcomes

1

Number of revision surgeries

Revision surgery of any component for any reason

Time frame
1 year postoperative
2

cost-effectiveness questionnaire

An economic evaluation will be performed from the societal perspective, for dislocation and Quality Adjusted Life Years (QALYs). Prevailing guidelines of Zorginstituut Nederland will be observed. All costs and consequences relevant to THA, hip dislocation and hip revision will be taken into account. To compare costs between groups, confidence intervals around the mean differences in costs at one year after THA will estimated using the bias-corrected and accelerated bootstrap method.

Time frame
1 year postoperative
3

Number of dislocations

Total number of dislocations

Time frame
2 years postoperative
4

Patient Reported Outcomes on physical functioning

Difference in patient reported outcomes on physical functioning following primary THA with a DM cup compared to a unipolar cup, measured with the Hip disability and Osteoarthritis Outcome Score Physical Short form (HOOS-PS). Interval level scores from 0 (no difficulty) to 100 (extreme difficulty).

Time frame
1 and 2 years postoperative

Other outcomes

Sponsors and contacts

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JointResearch

Lead sponsor

Source ClinicalTrials.gov
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