The primary objective is to investigate whether there is a difference in the number of hip dislocations and revisions following primary total hip arthroplasty (THA), using the posterolateral approach, with a DM cup compared to a unipolar cup in…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The number of dislocations, disregarding type of treatment (i.e. closed
repositioning or revision).
Secondary outcome
- 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.
Background summary
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 an RCT towards this aim.
Study objective
The primary objective is to investigate whether there is a difference in the
number of hip dislocations and revisions 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 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, blinded RCT nested in the LROI.
Intervention
The intervention group receives a THA with a dual mobility cup, the control
group receives a THA with a unipolar cup.
Study burden and risks
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).
Oosterpark 9
Amsterdam 1091 AC
NL
Oosterpark 9
Amsterdam 1091 AC
NL
Listed location countries
Age
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
- 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL64819.100.18 |