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

M

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

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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