Nexus Evaluation Primary Trident II UNcemented shEll (NEPTUNE): A Longitudinal Cohort Study of the Hydroxyapatite Coated Trident II Acetabular System in Total Hip Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- NHS Lothian
- Enrollment
- 125
- Locations
- 1
- Primary Endpoint
- Implant survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing planned primary total hip arthroplasty with standard implants, suitable for the use of the uncemented Trident® II acetabular component.
- •Patients aged 18-75
- •Patients willing and able to comply with the study protocol
- •Patients that provide informed consent
Exclusion Criteria
- •Patients not meeting study inclusion criteria
- •Bone stock that is inadequate for support or fixation of the prosthesis
- •Patients with a body mass index (kg/m2) >40
- •Procedures performed for pain relief in those with severely restricted mobility
Arms & Interventions
Trident® II HA coated shells
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.
Intervention: Stryker Trident® II HA coated cementless acetabula component (Device)
Outcomes
Primary Outcomes
Implant survival
Time Frame: 10 years
All failures or revision of the Trident® II components as well as liner revisions will be documented.
Secondary Outcomes
- Hip pain(Preoperative, 1, 2, 5, 7 and 10 years)
- Patient satisfaction(Preoperative, 1, 2, 5, 7 and 10 years)
- Oxford hip score(Preoperative, 1, 2, 5, 7 and 10 years)
- Forgotten Joint Score(Preoperative, 1, 2, 5, 7 and 10 years)
- Radiographic (x-ray) assessment(Preoperatively, 1, 5 and 10 years)
- Short Form 12(Preoperative, 1, 2, 5, 7 and 10 years)
- EuroQol 5-dimension(Preoperative, 1, 2, 5, 7 and 10 years)