Clinical trial NCT05366712: Nexus Evaluation Primary Trident II Uncemented Shell
Official title: Nexus Evaluation Primary Trident II UNcemented shEll (NEPTUNE): A Longitudinal Cohort Study of the Hydroxyapatite Coated Trident II Acetabular System in Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Arthritis of Hip
Hip Dysplasia
Hip Arthropathy
Hip Osteoarthritis
Keywords: Arthroplasty
Uncemented
Hip
Trident II
Lead sponsor: NHS Lothian
Sponsor class: OTHER_GOV
Collaborators: name: University of Edinburgh
First posted: 2022-05-09
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective Cohort Study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Implant survival
timeFrame: 10 years
Secondary outcomes:
measure: Oxford hip score
timeFrame: Preoperative, 1, 2, 5, 7 and 10 years
measure: Forgotten Joint Score
timeFrame: Preoperative, 1, 2, 5, 7 and 10 years
measure: Short Form 12
timeFrame: Preoperative, 1, 2, 5, 7 and 10 years
measure: EuroQol 5-dimension
timeFrame: Preoperative, 1, 2, 5, 7 and 10 years
measure: Hip pain
timeFrame: Preoperative, 1, 2, 5, 7 and 10 years
measure: Patient satisfaction
timeFrame: Preoperative, 1, 2, 5, 7 and 10 years
measure: Radiographic (x-ray) assessment
timeFrame: Preoperatively, 1, 5 and 10 years
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
state: Lothian
Study officials:
affiliation: NHS Lothian
name: Paul Gaston, MBChB, FRCS
role: PRINCIPAL_INVESTIGATOR
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