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Arthritis of HipNEPTUNENCT05366712

Nexus Evaluation Primary Trident II Uncemented Shell

A study testing Stryker Trident® II HA coated cementless acetabula component in people with Arthritis of Hip and Hip Dysplasia, run by NHS Lothian at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Arthritis of Hip, Hip Dysplasia, Hip Arthropathy
What is being tested?
Stryker Trident® II HA coated cementless acetabula component
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
1 siteUnited Kingdom
Study dates
1 Jun 2022to 25 Nov 2034
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • NHS Lothian

    Edinburgh, Lothian, EH16 4SA

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Being tested
Stryker Trident® II HA coated cementless acetabula component
Keywords
Arthroplasty, Uncemented, Hip, Trident II
Medical subject headings
Hip Dislocation, Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stryker Trident® II HA coated cementless acetabula componentDevice

    New acetabula component.

Study groups in NCT05366712
Study groupRoleWhat they receive
Trident® II HA coated shellsExperimentalPatients 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.
Receives: Device: Stryker Trident® II HA coated cementless acetabula component

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Implant survival

    All failures or revision of the Trident® II components as well as liner revisions will be documented.

    Measured: 10 years

Secondary outcomes (7)

  1. Oxford hip score

    The Oxford Hip Score is a patient reported outcome measure that was developed specifically to measure the impact of pain and functional disability in patients undergoing hip replacement. It consists of 12-questions and is scored using a 5-item Likert response format, reported on a 0 (worst) to 48 (best) scale with higher scores representing better outcomes. It is an extensively validated and widely adopted outcome measure in patients undergoing hip replacement surgery.

    Measured: Preoperative, 1, 2, 5, 7 and 10 years

  2. Forgotten Joint Score

    The Forgotten Joint Score-12 is a patient-reported outcome scale to assess joint awareness in hips during various activities of daily living. It uses a 5-point Likert response format, consists of 12-questions and the raw score is transformed to range from 0 (worst) to 100 (best) points. High scores indicate good outcome, i.e. a high degree of being able to forget about the affected joint in daily life. The FJS has a low ceiling effect and especially discriminates between good, very good and excellent outcome after THA and TKA. In its validation study it showed high internal consistency and discriminated well between patient groups known to show different outcome.

    Measured: Preoperative, 1, 2, 5, 7 and 10 years

  3. Short Form 12

    The Short Form 12 is a 12-item questionnaire used to assess generic health outcomes from the patient's perspective. The SF-12 results in two summary scores: the physical and mental components summary (PCS and MCS) scores. This score is calculated using norm-based methodology and population mean scores. Both PCS and MCS have a population mean score of 50 with an standard deviation of 10.

    Measured: Preoperative, 1, 2, 5, 7 and 10 years

  4. EuroQol 5-dimension

    The EuroQol 5-dimension is a standardised instrument with five items for use as a measure of self-reported general health. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status. This index for the UK population is on a scale of -0.594 to 1, where 1 represents perfect health and 0 represents death, with a utility of less than 0 being worse than death. It is one of the most frequently used measures to gain quality of life scores for analysis in health economy as utility weights for calculating quality of life adjusted life years (QALYs) can be obtained

    Measured: Preoperative, 1, 2, 5, 7 and 10 years

  5. Hip pain

    Global hip pain severity will be assessed using an 11 point (0-10) numerical rating scale (NRS), where 0 represents no pain and 10 the worst possible pain. The validity and sensitivity of the NRS has been well documented. As it has been suggested that using multiple measurements of pain status as opposed to a single value of 'current pain' may provide more realistic and meaningful measurements of pain intensity, separate assessments will be made of 'worst pain' and 'perceived mean daily pain' as has been specifically recommended for use in OA clinical trials.

    Measured: Preoperative, 1, 2, 5, 7 and 10 years

  6. Patient satisfaction

    Satisfaction questions are reported using a 5-point Likert response format hip (very satisfied, satisfied, unsure, dissatisfied or very dissatisfied). Specifically, questions will ask patients as to their

    1. overall satisfaction with their operated hip
    2. how well the surgery relieves pain in the operated joint
    3. how well surgery increases the ability to perform regular activities of daily living and to perform heavy work or sport activities

    Measured: Preoperative, 1, 2, 5, 7 and 10 years

  7. Radiographic (x-ray) assessment

    Plain radiographs will be obtained for assessment of fixation of the device evaluating radiolucent lines (mm), cup abduction angle (degrees), anteversion (degrees) and cup-centre-edge angle (degrees). Plain radiographs will be divided into the three acetabular zones according to those defined by DeLee and Charnley. Radiolucent lines will be defined as less then 2mm, more than this will be defined a lysis. Lysis in all three acetabular zone will define a loose cup. Acetabular component inclination and version will be calculated from anteroposterior radiographs of the hip and/or hip and pelvis using established and validated techniques. The safe zones for acetabular component positioning were assessed using the commonly adopted parameters defined by Lewinnek et al. (inclination of 30° to 50° and anteversion of 5° to 25°) and Callanan et al. (inclination of 30° to 45° and anteversion of 5° to 25°).

    Measured: Preoperatively, 1, 5 and 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2022
  2. Study start1 Jun 2022
  3. Primary completion25 Nov 2024
  4. Study completion25 Nov 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective Cohort Study
Masking
None (open label)
Enrolment
125 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05366712
Sponsor's protocol ID
AC20120
Acronym
NEPTUNE
Status last verified
Feb 2026
First submitted
4 May 2022
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to patient confidentiality there is no plans to share patient level data.

Publications

  • Dawson J, Fitzpatrick R, Carr A, Murray D. Questionnaire on the perceptions of patients about total hip replacement. J Bone Joint Surg Br. 1996 Mar;78(2):185-90.

    PubMed 8666621

  • Behrend H, Giesinger K, Giesinger JM, Kuster MS. The "forgotten joint" as the ultimate goal in joint arthroplasty: validation of a new patient-reported outcome measure. J Arthroplasty. 2012 Mar;27(3):430-436.e1. doi: 10.1016/j.arth.2011.06.035. Epub 2011 Oct 13.

    PubMed 22000572

  • Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

    PubMed 8628042

  • EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.

    PubMed 10109801

  • DeLee JG, Charnley J. Radiological demarcation of cemented sockets in total hip replacement. Clin Orthop Relat Res. 1976 Nov-Dec;(121):20-32.

    PubMed 991504

  • Liaw CK, Hou SM, Yang RS, Wu TY, Fuh CS. A new tool for measuring cup orientation in total hip arthroplasties from plain radiographs. Clin Orthop Relat Res. 2006 Oct;451:134-9. doi: 10.1097/01.blo.0000223988.41776.fa.

    PubMed 16721351

  • Park YS, Shin WC, Lee SM, Kwak SH, Bae JY, Suh KT. The best method for evaluating anteversion of the acetabular component after total hip arthroplasty on plain radiographs. J Orthop Surg Res. 2018 Apr 2;13(1):66. doi: 10.1186/s13018-018-0767-4.

    PubMed 29609639

  • Lewinnek GE, Lewis JL, Tarr R, Compere CL, Zimmerman JR. Dislocations after total hip-replacement arthroplasties. J Bone Joint Surg Am. 1978 Mar;60(2):217-20.

    PubMed 641088

  • Callanan MC, Jarrett B, Bragdon CR, Zurakowski D, Rubash HE, Freiberg AA, Malchau H. The John Charnley Award: risk factors for cup malpositioning: quality improvement through a joint registry at a tertiary hospital. Clin Orthop Relat Res. 2011 Feb;469(2):319-29. doi: 10.1007/s11999-010-1487-1.

    PubMed 20717858

Questions about this trial

What is this clinical trial studying?

A study testing Stryker Trident® II HA coated cementless acetabula component in people with Arthritis of Hip and Hip Dysplasia, run by NHS Lothian at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implant survival (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05366712, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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