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

Terminated

• Conditions: Osteoarthritis; Arthritis; Fracture of the Femoral Neck or Head; Avascular Necrosis; Congenital Hip Dysplasia
• Interventions: Device: Mpact Acetabular Shell

• Registration Number: NCT02196818
• Lead Sponsor: Medacta International SA

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-07-21
• Study First Posted: 2014-07-22
• Primary Completion: 2021-04
• Study Completion: 2022-04
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-20
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mpact Acetabular Shell	Mpact Acetabular Shell	Monitor the performance of the Mpact cup in the treatment of patients with hip joint disease requiring a total hip replacement.

Primary Outcome Measures

Name	Time	Method
The Kaplan-Meier analysis as a measure of implant performance.	5 years

Secondary Outcome Measures

Name	Time	Method
The Harris Hip Score.	pre-op, 3/6 months, 1,2 and 5 years
Radiological analysis as a meausure of safety.	3/6 months, 1,2 and 5 years

Trial Locations

Locations (4)

Illinois Bone & Joint Institute, LLC; 🇺🇸 Libertyville, Illinois, United States

Saint Alphonsus Regional Medical Center; 🇺🇸 Boise, Idaho, United States

Jordan Valley Medical Center; 🇺🇸 West Jordan, Utah, United States

Vail Orthopedics, P.C.; 🇺🇸 Denver, Colorado, United States