NCT02518269

A 3-Arm Study on G7 Acetabular Cup With Echo BiMetric Stem in Total Hip Arthroplasty

A Prospective 3-Arm Randomized Controlled Study on G7 Acetabular Cup With Echo BiMetric Stem in Total Hip Arthroplasty

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The study is designed to compare three articulation options in terms of osteolysis, patient satisfaction, clinical and radiographic outcomes (Oxford Hip score (OHS) and Harris Hip score (HHS) and safety. In addition, the purpose of the study is also to evaluate the safety and effectiveness of patients who received G7 Acetabular system in conjunction with Echo BiMetric stem in primary total hip arthroplasty.

Detailed description

DESIGN: Prospective 3 Arm Randomized controlled trial. PURPOSE:To compare three commonly used contemporary bearings in Total Hip Arthroplasty (THA). In addition, to evaluate the safety and effectiveness of the G7 Cups and Echo BiMetric Stem in THA. OUTCOME MEASURES: Osteolysis, clinical outcomes, patient satisfaction, intraoperative/surgical data, implant positioning, survivor ship, and adverse events. POPULATION: 360 hips (240 will have CT scan for analysis of osteolysis). ELIGIBILITY: Patients who meet inclusion and exclusion criteria defined in this protocol. DURATION: All patients will be followed at 3 months, 1, 2, 5, 7 and 10 year postoperatively. Assuming the enrollment will be completed 18 months. The total study duration will be 11.5 years. STUDY GROUPS/TREATMENTS Group 1 - G7 Metal-on-Polyethylene (MoP) (Arcom XL) + Echo BiMetric Group 2 - G7 Metal-on-Polyethylene (MoP) (E1) + Echo BiMetric Group 3 - G7 Ceramic-on-Ceramic (CoC) + Echo BiMetric The study's primary efficacy endpoint will include the difference in osteolytic volume at 5 years postoperatively measured by Computertomografi (CT) scan.

Conditions

• Osteoarthrosis
• Pain
• Arthritis

Interventions

Type	Name	Description
PROCEDURE	Hip Arthroplasty	Hip Arthroplasty comparing 3 different bearings.

Timeline

• Start date: 2015-05-04
• Primary completion: 2030-06-01
• Completion: 2030-11-30
• First posted: 2015-08-07
• Last updated: 2025-11-25

Locations

5 sites across 3 countries: Denmark, Finland, Sweden