Trilogy AB Acetabular Hip System Post Approval Study

Zimmer Biomet

Status and phase: Terminated; Phase 4

Conditions: Traumatic Arthritis; Osteoarthritis; Congenital Hip Dysplasia; Avascular Necrosis

Treatments: Device: Trilogy AB Acetabular Hip Implant System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00715026

06-300

06-300, Revised 3-1-2010 (Other Identifier)

Details and patient eligibility

About

This is a post-approval study with prospective enrollment in the United States and a retrospective enrollment outside the United States to obtain functional, quality of life and radiographic data, which will facilitate assessment of the clinical performance of the Zimmer Trilogy AB Acetabular Hip System.

Full description

To obtain functional, quality of life and radiographic data to evaluate the clinical performance of the Zimmer Trilogy AB Acetabular Hip System in primary total hip replacement surgery.

Enrollment: 31 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-obese patients
• The patient is a good candidate for a primary hip arthroplasty using the Zimmer Trilogy AB Acetabular Hip System.
• Patient is willing and able to give informed consent to participate in the follow-up program.
• Patient is suitable for surgery and able to participate in the follow-up program.

Exclusion criteria

• Skeletally immature
• Rheumatoid arthritis
• Osteoradionecrosis
• Infection
• Nerve or muscle disease that may have a negative affect on gait or weight bearing
• Loss of abductor musculature in the affected limb
• Poor bone stock
• Poor skin coverage around the hip joint
• Rapid disease progression as obvious by joint destruction or bone absorption seen on x-ray
• Previous total or cemented hemi-arthroplasty of the affected hip
• Previous pinning or plating of the affected hip
• Patients with heavy labor jobs or extreme activity levels
• Patients who participate in sports activities or require deep flexion
• Patients who are obese
• Patients who have other disabilities
• Patients who are unwilling or unable to give consent, or to comply with the protocol and follow-up program.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Trilogy AB Acetabular Hip Implant System

Other group

Description:

Post Approval Study of Device.

Treatment:

Device: Trilogy AB Acetabular Hip Implant System