A Prospective RSA and Clinical Evaluation of the Trident II Acetabular Cup

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.

Study Overview

• Status: Unknown
• Conditions: Total Hip Arthroplasty; Acetabular Cup
• Intervention / Treatment: Radiation: Radiostereometric Analysis; Procedure: total hip arthroplasty with RSA bead implantation

Detailed Description

The proposed study is a prospective evaluation of data from patients undergoing primary total hip arthroplasty using the Trident II acetabular cup. Fifty patients will be recruited for this study. All patients that qualify for the study per the inclusion-exclusion criteria and provide written informed consent will receive the Trident II acetabular cup and RSA beads. Implant stability, through RSA, will be measured throughout the first two postoperative (post-op) years per the following schedule: immediate post-op and 6 weeks, 3 months, 6 months, 1 year, and 2 years following surgery. Patients will be discharged and seen for follow-up assessments as per standard of care. Adverse events that are related to the index joint will be collected. Health outcome questionnaires will be collected. The health outcome questionnaires will include: EQ-5D, HOOS JR and Harris Hip Score. Health outcome questionnaires will be completed pre-operatively and again at 6 weeks, 3 months, 6 months, 1 year and 2 years following surgery. Conventional x-ray analysis will be performed pre-operatively and again at 6 weeks, 1 year and 2 years following surgery.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Naperville, Illinois, United States, 60563
      • Midwest Orthopaedics at Rush

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Trident II acetabular cup; Subjects receive the Trident II acetabular cup and RSA beads and undergo a series of post-operative RSA exams.	Radiation: Radiostereometric Analysis; 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; Procedure: total hip arthroplasty with RSA bead implantation; Patients receive RSA beads inserted into the bone surrounding the Trident II implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
What are the migration patterns of the Trident II acetabular cup over the first two post-operative years?	Migration patterns will be assessed using RSA analysis.	3 years
Is there a significant difference in health status and functional outcome before and after hip arthroplasty using Trident II Cup?	The health status and functional outcome will be assessed via Harris Hip Score.	3 years
Is there a significant difference in health status and functional outcome before and after hip arthroplasty using Trident II Cup?	The health status and functional outcome will be assessed via EQ-5D.	3 years
Is there a correlation between radiolucent lines measured by Charnley-DeLee zone analysis and migration characteristics using RSA?	X-ray radiographs will be taken at pre-op, 6 weeks, 1 year and 2 year appointments. It may take up to 3 years after study start for all patients to reach the 2 year visit mark, depending on how long enrollment takes.	3 years
Can inducible displacements measured at 1 year post-operative distinguish patients identified by RSA measurements as having inadequate fixation?	Inducible displacements will be measured using RSA exams at the 1 year follow-up. It may take up to 2 years after study start for all patients to reach the 1 year visit mark, depending on how long enrollment takes.	2 years

Collaborators and Investigators

• Sponsor: Midwest Orthopaedics at Rush
• Investigators: Principal Investigator: Scott Sporer, MD, Midwest Orthopaedics at Rush

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2017
• Primary Completion (Anticipated): October 9, 2020
• Study Completion (Anticipated): February 9, 2022

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (Actual): August 25, 2017

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 12, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: THA; RSA; Trident
• Other Study ID Numbers: 17-066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes