Active — Not RecruitingNot Applicable

Nexus Evaluation Primary Trident II Uncemented Shell

United Kingdom125 participantsStarted 2022-06-01

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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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

What they're measuring

Implant survival

Timeframe: 10 years

Trial details

NCT IDNCT05366712

SponsorNHS Lothian

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-11-25

View on ClinicalTrials.gov More Arthritis of Hip trials