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Trial record 56 of 2647 for:    ( Map: Idaho, United States )

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

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ClinicalTrials.gov Identifier: NCT02196818
Recruitment Status : Recruiting
First Posted : July 22, 2014
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Medacta International SA

Brief 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.

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

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : March 2013
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024

Group/Cohort Intervention/treatment
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




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

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


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary total hip arthroplasty
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02196818


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

Locations
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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         
United States, Utah
Jordan Valley Medical Center Recruiting
West Jordan, Utah, United States, 84088
Contact: Charles Marshall, MD         
Principal Investigator: Charles Marshall, MD         
Sponsors and Collaborators
Medacta International SA

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Responsible Party: Medacta International SA
ClinicalTrials.gov Identifier: NCT02196818     History of Changes
Other Study ID Numbers: P01.014.08/00
First Posted: July 22, 2014    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Hip Dislocation
Hip Dislocation, Congenital
Necrosis
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes
Joint Dislocations
Wounds and Injuries
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities