Clinical trial NCT04031820: Dual-mobility Cups Compared to Unipolar Cups on Dislocation and Cost-effectiveness After Primary Total Hip Arthroplasty.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Total Hip Arthroplasty
Osteoarthritis, Hip
Keywords: Primary total hip arthroplasty
Dual Mobility cup
Lead sponsor: JointResearch
Sponsor class: OTHER
First posted: 2019-07-24
Enrollment: 1100
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Rationale: Dislocation is the leading reason for early revision surgery. To address the problem of dislocation, the dual-mobility (DM) cup was developed in France in the 1970's. This cup should provide more stability and biomechanically reduce the risk of dislocation. In the Netherlands, most DM cups are placed in specific patients, e.g. with cognitive impairment and for revisions due to recurrent dislocations. Despite the increased and, in some countries, broad use of DM cups, high quality evidence of their (cost)effectiveness is lacking. This study aims to perform a trial to fill this gap in knowledge. Much of the information needed to judge the effectiveness of DM cups is already incorporated in the Dutch Arthroplasty Register (LROI). This register lends itself perfectly for a nested RCT towards this aim.

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. The secondary objectives are: to investigate whether there is a difference in the number of revisions; to investigate what the cost-effectiveness and cost-utility is of a DM cup compared to a unipolar cup at 1 year follow-up; to investigate whether there is a difference in the number of hip dislocations and revisions between a DM cup and a unipolar cup 2 years after surgery; to investigate whether there is a difference in patient reported outcomes between a DM cup compared to a unipolar cup 1 and 2 years after surgery; to compare the number of hip dislocations, revisions and PROM data between patients in the randomized DM group and patients in an observational cohort DM group. Finally, long-term survival of DM and unipolar cups will be evaluated based on revision and mortality data registered in the LROI.

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.

Intervention (if applicable): The intervention group receives a THA with a dual mobility cup, the control group receives a THA with a unipolar cup.

Main study parameters/endpoints: Primary: The number of dislocations. Secondary: costs, patient reported outcomes and implant survival.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In addition to the benefits from regular care, the primary hip arthroplasty procedure, patients might benefit from randomization to receiving a DM cup. DM cups are designed to reduce the risk of hip dislocation, compared to a unipolar cup. Patients may undergo more thorough follow-up than non-study patients and may benefit from this increased surveillance compared with regular care. The only burden associated with study participation is the time needed to complete the cost questionnaires (all other outcomes are part of standard care).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria

* 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.

Primary outcomes:
measure: Number of dislocations
timeFrame: 1 year postoperative
Secondary outcomes:
measure: Number of revision surgeries
timeFrame: 1 year postoperative
measure: cost-effectiveness questionnaire
timeFrame: 1 year postoperative
measure: Number of dislocations
timeFrame: 2 years postoperative
measure: Patient Reported Outcomes on physical functioning
timeFrame: 1 and 2 years postoperative
measure: Patient Reported Outcomes on pain
timeFrame: 1 and 2 years postoperative
measure: Patient Reported Outcomes on quality of life
timeFrame: 1 and 2 years postoperative
measure: Implant survival
timeFrame: 5 - 10 years postoperative
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: OLVG
Study officials:
affiliation: OLVG, Amsterdam, the Netherlands
name: Rudolf Poolman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.