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

Medacta

Status: Terminated

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

Treatments: Device: Mpact Acetabular Shell

Study type: Observational

Funder types: Industry

Identifiers

NCT02196818

P01.014.08/00

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

Mpact Acetabular Shell

Description:

Monitor the performance of the Mpact cup in the treatment of patients with hip joint disease requiring a total hip replacement.

Treatment:

Device: Mpact Acetabular Shell