A Multi-centre, Prospective Surveillance to Assess Mid-term Performance of the Mpact Cup

N/ATerminatedNCT02196818

Medacta International SA200 enrolled

Overview

This is a multi-centre, prospective post marketing surveillance study to assess mid-term performance of the Mpact cup in subjects requiring primary total hip arthroplasty.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Osteoarthritis Arthritis Avascular Necrosis Fracture of the Femoral Neck or Head Congenital Hip Dysplasia

Interventions

Mpact Acetabular ShellDEVICE

Total Hip Replacement

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery. * Those presenting with disease that meets the indications for use for Medacta USA implants defined by this study (on-label use). * Patients must be willing to comply with the pre and post-operative evaluation schedule. Exclusion Criteria: * Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study.

Locations (4)

Vail Orthopedics, P.C.

Denver, Colorado, United States

Saint Alphonsus Regional Medical Center

Boise, Idaho, United States

Illinois Bone & Joint Institute, LLC

Libertyville, Illinois, United States

Jordan Valley Medical Center

West Jordan, Utah, United States

Outcomes

Primary Outcomes

The Kaplan-Meier analysis as a measure of implant performance.

Time frame: 5 years

Secondary Outcomes

The Harris Hip Score.

Time frame: pre-op, 3/6 months, 1,2 and 5 years

Radiological analysis as a meausure of safety.

Time frame: 3/6 months, 1,2 and 5 years

Data from ClinicalTrials.gov

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