Nexus Evaluation Primary Trident II Uncemented Shell (NEPTUNE)

NHS Lothian

Status: Active, not recruiting

Conditions: Arthritis of Hip; Hip Arthropathy; Hip Osteoarthritis; Hip Dysplasia

Treatments: Device: Stryker Trident® II HA coated cementless acetabula component

Study type: Interventional

Funder types: Other

Identifiers

NCT05366712

AC20120

Details and patient eligibility

About

This is a prospective cohort study assessing the survival of a new acetabula component which is based on the original Trident acetabular system (cementless shell) which is used for Total Hip Arthroplasty. The manufacturer recently introduced the evolution of this product, the Trident® II acetabular shell which was launched in 2017. This implant is CE marked and is now widely available for the UK market, however has minimal clinical outcomes data to support its use. As part of a stepwise introduction of devices to orthopaedic practice. This study will report the 10 year implant survival and patient functional outcomes of this new implant.

Full description

125 patients will be recruited at a single-centre as part of a, phase-4 post-market surveillance, prospective cohort study

This is a 10-year study of the Trident II acetabular component as part of total hip replacement at the Royal Infirmary of Edinburgh, NHS Lothian.

Patients will receive a Trident® II acetabular component as part of primary total hip arthroplasty at the study centre. This component is CE marked and widely available for use by UK surgeons. The Trident® II shells are HA coated, cementless, press-fit acetabular shells composed of a Titanium (Ti-6Al-4V) substrate featuring a CpTi roughened surface with PureFix™ HA. The cup is available in a range of sizes and is indicated for primary and revision procedures.

A standard operative technique will be employed by all study surgeons, using the posterior approach. The routine post-operative patient care protocol of the study centre will be employed.

10 year implant survival is the primary aim, but in addition functional and radiographical outcome will be assessed a 1, 2, 5, 7 and 10 years.

Enrollment: 125 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients undergoing planned primary total hip arthroplasty with standard implants, suitable for the use of the uncemented Trident® II acetabular component.
2. Patients aged 18-75
3. Patients willing and able to comply with the study protocol
4. Patients that provide informed consent

Exclusion criteria

1. Patients not meeting study inclusion criteria
2. Bone stock that is inadequate for support or fixation of the prosthesis
3. Patients with a body mass index (kg/m2) >40
4. Procedures performed for pain relief in those with severely restricted mobility

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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125 participants in 1 patient group

Trident® II HA coated shells

Experimental group

Description:

Patients will receive a Trident® II acetabular component as part of primary total hip arthroplasty at the study centre. This component is CE marked and widely available for use by UK surgeons. The Trident® II shells are HA coated, cementless, press-fit acetabular shells composed of a Titanium (Ti-6Al-4V) substrate featuring a CpTi roughened surface with PureFix™ HA.

Treatment:

Device: Stryker Trident® II HA coated cementless acetabula component