NCT03261986

Brief Summary

The objective of this study is to use radiostereometric analysis (RSA) and clinical outcome measures to evaluate early post-operative implant stability and the clinical performance of Stryker's Trident II Acetabular Cup.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 9, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2022

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

3.3 years

First QC Date

August 23, 2017

Last Update Submit

March 12, 2020

Conditions

Total Hip ArthroplastyAcetabular Cup

Keywords

TridentRSATHA

Outcome Measures

Primary Outcomes (1)

  • Does the Trident II Cup achieve acceptable fixation to the underlying bone?

    The Trident II Cup proximal migration will be assessed. Migration of less than 0.2mm at 2 years and without continuous migration between post-operative year 1 and 2 will indicate acceptable fixation.

    3 years

Secondary Outcomes (5)

  • What are the migration patterns of the Trident II acetabular cup over the first two post-operative years?

    3 years

  • Is there a significant difference in health status and functional outcome before and after hip arthroplasty using Trident II Cup?

    3 years

  • Is there a significant difference in health status and functional outcome before and after hip arthroplasty using Trident II Cup?

    3 years

  • Is there a correlation between radiolucent lines measured by Charnley-DeLee zone analysis and migration characteristics using RSA?

    3 years

  • Can inducible displacements measured at 1 year post-operative distinguish patients identified by RSA measurements as having inadequate fixation?

    2 years

Study Arms (1)

Trident II acetabular cup

OTHER

Subjects receive the Trident II acetabular cup and RSA beads and undergo a series of post-operative RSA exams.

Radiation: Radiostereometric AnalysisProcedure: total hip arthroplasty with RSA bead implantation

Interventions

Radiostereometric AnalysisRADIATION

RSA exams of the operative hip are received post-op day 1, and at 6 weeks, 3 months, 6 months, 1 year and 2 years following surgery

Trident II acetabular cup
total hip arthroplasty with RSA bead implantationPROCEDURE

Patients receive RSA beads inserted into the bone surrounding the Trident II implant.

Trident II acetabular cup

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic arthritis of the hip indicating surgical intervention
  • Scheduled to undergo a primary total hip arthroplasty
  • Patient is a candidate for the Trident II acetabular cup in accordance with product labeling -

You may not qualify if:

  • Patients less than 18 years of age, or older than 85 years of age.
  • Severe hip dysplasia (Crowe Type III or IV) in the affected hip
  • History of congenital dislocation
  • Prior arthroplasty of the affected hip
  • Active or prior infection of the affected hip
  • Morbid obesity (BMI \> 40)
  • Medical condition precluding major surgery
  • Severe osteoporosis
  • Neuromuscular impairment
  • Patients with known allergy to metals
  • Pregnancy
  • Patients on dialysis or creatinine \> 2.0
  • Patient is immuno-suppressed -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Midwest Orthopaedics at Rush

Naperville, Illinois, 60563, United States

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Scott Sporer, MD

    Midwest Orthopaedics at Rush

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 23, 2017

First Posted

August 25, 2017

Study Start

June 9, 2017

Primary Completion

October 9, 2020

Study Completion

February 9, 2022

Last Updated

March 17, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)