Nexus Evaluation Primary Trident II Uncemented Shell

NCT05366712 | Active Not Recruiting

• 1 other identifier: AC20120
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis of Hip; Hip Dysplasia; Hip Arthropathy; Hip Osteoarthritis

Keywords

Arthroplasty; Uncemented; Hip; Trident II

Outcome Measures

Primary Outcomes (1)

• Implant survival

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

  10 years

Secondary Outcomes (7)

• Oxford hip score

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

• Forgotten Joint Score

  Preoperative, 1, 2, 5, 7 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

• Hip pain

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

Study Arms (1)

Trident® II HA coated shells

EXPERIMENTAL

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

Interventions

Stryker Trident® II HA coated cementless acetabula component DEVICE

New acetabula component.

Trident® II HA coated shells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Lothian: lead
• University of Edinburgh: collaborator

Study Sites (1)

NHS Lothian

Edinburgh, Lothian, EH16 4SA, United Kingdom

Location

Related Publications (9)

• 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.

  PMID: 8666621 BACKGROUND

• 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.

  PMID: 22000572 BACKGROUND

• 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.

  PMID: 8628042 BACKGROUND

• 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.

  PMID: 10109801 BACKGROUND

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

  PMID: 991504 BACKGROUND

• 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.

  PMID: 16721351 BACKGROUND

• 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.

  PMID: 29609639 BACKGROUND

• 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.

  PMID: 641088 BACKGROUND

• 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.

  PMID: 20717858 BACKGROUND

Related Links

• Edinburgh Orthopaedic home page

MeSH Terms

Conditions

Hip Dislocation; Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries; Osteoarthritis; Arthritis; Rheumatic Diseases

Study Officials

• Paul Gaston, MBChB, FRCS

  NHS Lothian

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Prospective Cohort Study

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 9, 2022
• Study Start: June 1, 2022
• Primary Completion: November 25, 2024
• Study Completion (Estimated): November 25, 2034
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)