DUALITY: Dual Mobility Cups in Hip Fracture Patients

Sponsor

Uppsala University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03909815

Collaborator

The Swedish Research Council (Other)

1,600

Enrollment

Location

Arms

38.4

Anticipated Duration (Months)

41.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Our aim is to develop a strategy that reduces the risk of dislocations after total hip arthroplasty surgery performed due to femoral neck fracture. We therefore perform a register-nested, pragmatic, randomized controlled trial to investigate the safety and efficacy of dual mobility cups that were designed to minimize the risk of dislocation in the large and fragile group of elderly patients with femoral neck fractures.

Condition or Disease	Intervention/Treatment	Phase
Femoral Neck Fractures	Device: Dual mobility cup Device: Standard cup	N/A

Detailed Description

Total hip arthroplasty (THA) is regularly performed in patients with a femoral neck fracture. However, dislocation is very common after THA in hip fracture patients, and this complication is deleterious to health and quality of life. The dual mobility cup offers a technical solution that potentially reduces the risk of dislocation. There is however no high-level evidence to support the general use of dual mobility cups in patients with displaced femoral neck fractures, and the purpose of the proposed study is to provide evidence to support or refute the use of this concept in the very large group of hip fracture patients.

We a register-nested, pragmatic randomized controlled trial (RCT) to investigate the safety and efficacy of dual mobility cups that were designed to minimize the risk of dislocation after THA. Our aim is thus to investigate whether the incidence of dislocations after THA surgery performed due to femoral neck fracture can be reduced by the use of this device.

The intervention group receives a dual mobility cup (of any brand that is in general use in Sweden), and the control group receives a standard cup (of any brand that is in general use in Sweden). The choice of cup or stem fixation (cemented or uncemented), femoral head size, brand of stem type, surgical approach, antibiotic prophylaxis, and postoperative mobilization are up to the surgeon's choice and the routines that are relevant at each study site.

The necessary infrastructure for this register-nested RCT is present within the Swedish Hip Arthroplasty Register (SHAR) and the Swedish Fracture Register (SFR). Pre-operative registration of fractures is already established within the SFR, and an online platform to screen, include and randomize eligible patients is established. Cross-matching of data from the SFR and the SHAR with the database of the Swedish Patient Register (SPR) is performed in order to catch endpoint not routinely collected by the SHAR.

Intends to expand the recruitment to UK by utilizing the WHITE-PLATFORM.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Do Dual Mobility Cups Prevent Dislocation After Total Hip Arthroplasty Performed Due to Femoral Neck Fracture? A Registry-based, Pragmatic, Randomized Controlled Trial Comparing Dual Mobility With Standard Cups

Actual Study Start Date :

Jan 17, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Insertion of dual mobility cup	Device: Dual mobility cup Patients with a displaced femoral neck fracture eligible for THA receive a dual mobility cup, as opposed to a standard cup in the control group.
Active Comparator: Control Insertion of standard cup	Device: Standard cup Patients with a displaced femoral neck fracture eligible for THA receive a standard cup, as opposed to a dual mobility cup in the experimental group.

Arm

Intervention/Treatment

Experimental: Intervention

Insertion of dual mobility cup

Device: Dual mobility cup

Patients with a displaced femoral neck fracture eligible for THA receive a dual mobility cup, as opposed to a standard cup in the control group.

Active Comparator: Control

Insertion of standard cup

Device: Standard cup

Patients with a displaced femoral neck fracture eligible for THA receive a standard cup, as opposed to a dual mobility cup in the experimental group.

Outcome Measures

Primary Outcome Measures

Dislocation [1 year after index surgery]
Dislocation will be ascertained by identifying the occurrence of any closed or open reduction of the previously inserted THA (the "index joint") within one year after surgery.

Secondary Outcome Measures

Any re-operation of the index THA [1 year after index surgery]
Re-operation will be defined as the occurrence of any surgical procedure performed on the previously treated hip within one year after surgery.
Periprosthetic joint infection [1 year after index surgery]
Periprosthetic joint infection will be defined as the occurrence of any sign of deep infection around the previously inserted THA within one year after surgery, defined by registration of ICD or NOMESCO codes.
Patient-reported outcome [1 year after index surgery]
Patient-reported outcome as assessed by EQ-5D-VAS (routinely collected by the SFR at index surgery in order to obtain pre-trauma baseline, and 1 year post-operatively)
Short-term mortality [90 days after index surgery]
90-day mortality, as registered in the NPR
Medium-term mortality [365 days after index surgery]
365-day mortality, as registered in the NPR
Cost-effectiveness [1 year after index surgery]
Procedural costs for intervention and control treatment will be recorded at all sites, ensuring documentation of baseline costs for the two treatment alternatives. Procedural costs of admissions for closed reductions as well as for reoperations will also be collected from all units.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Written informed consent
Diagnosis: displaced femoral neck fracture type AO 31-B2 or B3/Garden type 3 or 4
Eligible for THA according to local guidelines and routines

Exclusion Criteria:

Previous inclusion of contralateral hip
Delayed fracture surgery (date of injury >7 days prior to date of randomization)
Pathological or stress fracture of the femoral neck, or fracture adjacent to a previous ipsilateral hip implant
Inability or unwillingness to give written consent
Dementia (as diagnosed by the screening physician)
Unavailability of both interventions for a study subject (e.g., implants being out of stock, or lack of the individual surgeon's expertise to perform either procedure)