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
• Status: Terminated
• 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
• 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.

Related Conditions & MeSH terms

• Arthritis
• Avascular Necrosis
• Congenital Hip Dysplasia
• Developmental Dysplasia of the Hip
• Fracture of the Femoral Neck or Head
• Hip Dislocation
• Hip Dislocation, Congenital
• Necrosis
• Osteoarthritis

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