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NCT02196818 Clinical Trial

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

Osteoarthritis Clinical Trial

Official title:
A Multi-centre, Prospective Post Marketing Surveillance Study to Assess Mid-term Performance of the Mpact Cup in Subjects Requiring Primary Total Hip Arthroplasty

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02196818
Other study ID # P01.014.08/00
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date March 2013
Est. completion date April 2022

Study information
Verified date March 2023
Source Medacta International SA
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Terminated
Enrollment 200
Est. completion date April 2022
Est. primary completion date April 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Mpact Acetabular Shell
Total Hip Replacement

Locations
Country Name City State
United States Saint Alphonsus Regional Medical Center Boise Idaho
United States Vail Orthopedics, P.C. Denver Colorado
United States Illinois Bone & Joint Institute, LLC Libertyville Illinois
United States Jordan Valley Medical Center West Jordan Utah

Sponsors (1)
Lead Sponsor Collaborator
Medacta International SA

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The Kaplan-Meier analysis as a measure of implant performance. 5 years
Secondary The Harris Hip Score. pre-op, 3/6 months, 1,2 and 5 years
Secondary Radiological analysis as a meausure of safety. 3/6 months, 1,2 and 5 years
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