Nexus Evaluation Primary Trident II Uncemented Shell

Status Recruiting

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05366712
Study type	Interventional
Source	NHS Lothian
Contact	Nick D Clement, MBBS, MD, PhD
Phone	+441315361000
Email	nick.clement@nhslothian.scot.nhs.uk
Status	Recruiting
Phase	N/A
Start date	June 1, 2022
Completion date	February 2034

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03326804` - H1 Hip Resurfacing Arthroplasty
Not yet recruiting	`NCT04257682` - Regional Anesthesia in Total Hip and Knee Arthroplasty	Phase 4
Completed	`NCT02876120` - The STavanger osteoARThritis Study	N/A
Terminated	`NCT02231567` - Neurocognitive Rehabilitation After Hip Replacement	N/A
Recruiting	`NCT02174965` - Wear and Migration in the Corin Mini-Hip/Metafix and ECIMA Polyethylene	N/A
Completed	`NCT01506024` - Minimal Invasive Surgery in Total Hip Arthroplasty Patients; Short- and Long Term Results	N/A
Active, not recruiting	`NCT04070027` - Progressive Resistance Training Versus Total Hip Arthroplasty in Patients With Hip Osteoarthritis	N/A
Withdrawn	`NCT04421196` - Opioid-free Total Hip Arthroplasty	N/A
Not yet recruiting	`NCT05960903` - Patient Satisfaction After Primary THA In Assiut University
Completed	`NCT04084704` - A Prospective Evaluation of the Cingal Injection for Hip Osteoarthritis	N/A
Not yet recruiting	`NCT04018690` - Project Arthritis Recovering Quality of Life Through Education - Hip	N/A
Completed	`NCT03648060` - Efficacy of a Digital Biofeedback System for Home-based Rehabilitation After Total Joint Replacement	N/A
Recruiting	`NCT05497349` - Use of Leukocyte-Rich PRP or Leukocyte-Free PRP in the Treatment of Hip Osteoarthritis	N/A
Active, not recruiting	`NCT04879732` - RSA - ACTIS Hip Stem	N/A
Active, not recruiting	`NCT05142462` - Post Market Clinical Follow-up of EUROSCUP Fixe Acetabular Cup
Recruiting	`NCT04665908` - PT-led Triage for Patients With Hip o Knee Osteoarthritis	N/A
Completed	`NCT04648956` - Arabic Version of the ICOAP Questionnaire
Recruiting	`NCT05465096` - Treatment of Osteoarthritis of the Hip Joint With Intra-articular Injection of Microfractured Autologous Adipose Tissue Containing Mesenchymal Stromal Cells.	N/A
Completed	`NCT02884531` - Patient Education and Basic Body Awareness Therapy in Hip Osteoarthritis: a Randomized Controlled Trial	N/A
Completed	`NCT03031314` - Comparison of Knotless Barbed Suture and Standard Suture in Knee Replacement Patients	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Nexus Evaluation Primary Trident II Uncemented Shell — NEPTUNE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms