This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback
Trial record 2 of 10 for:    MPACT

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

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2016 by Medacta International SA
Information provided by (Responsible Party):
Medacta International SA Identifier:
First received: July 7, 2014
Last updated: April 7, 2016
Last verified: April 2016
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.

Condition Intervention
Osteoarthritis Arthritis Avascular Necrosis Fracture of the Femoral Neck or Head Congenital Hip Dysplasia Device: Mpact Acetabular Shell

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Medacta International SA:

Primary Outcome Measures:
  • The Kaplan-Meier analysis as a measure of implant performance. [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • The Harris Hip Score. [ Time Frame: pre-op, 3/6 months, 1,2 and 5 years ]
  • Radiological analysis as a meausure of safety. [ Time Frame: 3/6 months, 1,2 and 5 years ]

Estimated Enrollment: 200
Study Start Date: March 2013
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Mpact Acetabular Shell
Monitor the performance of the Mpact cup in the treatment of patients with hip joint disease requiring a total hip replacement.
Device: Mpact Acetabular Shell
Total Hip Replacement


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02196818

Contact: Mara Colombo 0041 91 6966060

United States, Colorado
Vail Orthopedics, P.C. Recruiting
Denver, Colorado, United States, 80230
Contact: Derek Johnson, MD    303-214-4500   
Principal Investigator: Derek Johnson, MD         
United States, Idaho
Saint Alphonsus Regional Medical Center Recruiting
Boise, Idaho, United States, 83702
Contact: Dennis McGee, MD   
Principal Investigator: Dennis McGee, MD         
United States, Illinois
Illinois Bone & Joint Institute, LLC Recruiting
Libertyville, Illinois, United States, 60048
Contact: Peter Thadani, MD    847-247-4000   
Contact: Keri Malcom    847.247.4000   
Principal Investigator: Peter Thadani, MD         
Sub-Investigator: Keri Malcom         
Sponsors and Collaborators
Medacta International SA
  More Information

Responsible Party: Medacta International SA Identifier: NCT02196818     History of Changes
Other Study ID Numbers: P01.014.08/00
Study First Received: July 7, 2014
Last Updated: April 7, 2016

Additional relevant MeSH terms:
Hip Dislocation, Congenital
Hip Dislocation
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Musculoskeletal Abnormalities
Congenital Abnormalities
Wounds and Injuries
Hip Injuries processed this record on June 26, 2017