A 3-Arm Study on G7 Acetabular Cup With Echo BiMetric Stem in Total Hip Arthroplasty
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Arthritis
- Osteoarthrosis
- Pain
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
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, pa...
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.
Tracking Information
- NCT #
- NCT02518269
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Anders Troelsen, MD, PhD Hvidovre University Hospital Principal Investigator: Henrik Malchau, MD, PhD Sahlgrenska University Hospital, Sweden Principal Investigator: Ville Remes, MD, PhD Jokilaakson Terveys Oy
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