Trial record 2 of 7 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 2015 by Medacta International SA
Sponsor:
Information provided by (Responsible Party):
Medacta International SA
ClinicalTrials.gov Identifier:
NCT02196818
First received: July 7, 2014
Last updated: April 14, 2015
Last verified: April 2015
  Purpose

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The Harris Hip Score. [ Time Frame: pre-op, 3/6 months, 1,2 and 5 years ] [ Designated as safety issue: No ]
  • Radiological analysis as a meausure of safety. [ Time Frame: 3/6 months, 1,2 and 5 years ] [ Designated as safety issue: Yes ]

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT02196818

Contacts
Contact: Mara Colombo 0041 91 6966060 colombo@medacta.ch

Locations
United States, Colorado
Vail Orthopedics, P.C. Recruiting
Denver, Colorado, United States, 80230
Contact: Derek Johnson, MD    303-214-4500    derek@webproze.com   
Principal Investigator: Derek Johnson, MD         
United States, Idaho
Saint Alphonsus Regional Medical Center Recruiting
Boise, Idaho, United States, 83702
Contact: Dennis McGee, MD       dennmcge@sarmc.org   
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    pjtmd1@gmail.com   
Contact: Keri Malcom    847.247.4000    kmalcolm@ibji.com   
Principal Investigator: Peter Thadani, MD         
Sub-Investigator: Keri Malcom         
Sponsors and Collaborators
Medacta International SA
  More Information

No publications provided

Responsible Party: Medacta International SA
ClinicalTrials.gov Identifier: NCT02196818     History of Changes
Other Study ID Numbers: P01.014.08/00
Study First Received: July 7, 2014
Last Updated: April 14, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hip Dislocation, Congenital
Congenital Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 02, 2015