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

NCT ID: NCT03261986

Last Updated: 2020-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-09
• Study Completion Date: 2022-02-09

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.

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.

Conditions

Total Hip Arthroplasty; Acetabular Cup

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Trident II acetabular cup

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

Group Type: OTHER

Radiostereometric Analysis

Intervention Type: RADIATION

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

total hip arthroplasty with RSA bead implantation

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: RADIATION

total hip arthroplasty with RSA bead implantation

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

Intervention Type: PROCEDURE

Eligibility Criteria

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 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Midwest Orthopaedics at Rush

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Sporer, MD

Role: PRINCIPAL_INVESTIGATOR

Midwest Orthopaedics at Rush

Locations

Midwest Orthopaedics at Rush

Naperville, Illinois, United States

Countries

United States

Other Identifiers

17-066

Identifier Type: -

Identifier Source: org_study_id