Thinking of joining a study?

Register your interest

NCT05366712 | Recruiting | Arthritis of Hip


Nexus Evaluation Primary Trident II Uncemented Shell
Sponsor:

NHS Lothian

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.

Condition or disease

Arthritis of Hip

Hip Dysplasia

Hip Arthropathy

Hip Osteoarthritis

Intervention/treatment

Stryker Trident® II HA coated cementless acetabula component

Phase

Not Applicable

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 Type : Interventional
Estimated Enrollment : 125 participants
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 1, 2022
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : February 2034
Arm Intervention/treatment

Experimental: 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.

Device: Stryker Trident® II HA coated cementless acetabula component

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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

Nexus Evaluation Primary Trident II Uncemented Shell

Location Details


Please Choose a site



Nexus Evaluation Primary Trident II Uncemented Shell

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

United Kingdom, Lothian

NHS Lothian

Edinburgh, Lothian, United Kingdom, EH16 4SA

Loading...