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Assess the Mid-term Performance of the Mpact Cup in Subjects Requiring Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT03897595
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Medacta USA

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

Condition or disease Intervention/treatment Phase
Hip Osteoarthritis Device: Quadra®-H, Quadra®-C, AMIStem®-H or AMIStem®-C femoral stem and Mpact® Acetabular hip system with CoCr Femoral Head or Ceramic MectaCer BIOLOX® Femoral Head Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Quadra®-H, Quadra®-C, AMIStem®-H or AMIStem®-C femoral stem and Mpact® Acetabular hip system with CoCr Femoral Head or Ceramic MectaCer BIOLOX® Femoral Head
Masking: None (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
Actual Study Start Date : October 2012
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
Mpact cup
Quadra®-H, Quadra®-C, AMIStem®-H or AMIStem®-C femoral stem and Mpact® Acetabular hip system with CoCr Femoral Head or Ceramic MectaCer BIOLOX® Femoral Head
Device: Quadra®-H, Quadra®-C, AMIStem®-H or AMIStem®-C femoral stem and Mpact® Acetabular hip system with CoCr Femoral Head or Ceramic MectaCer BIOLOX® Femoral Head
Hip replacement using Medacts's Mpact cup
Other Name: Hip replacement




Primary Outcome Measures :
  1. Change from baseline Harris Hip Scores (HHS) [ Time Frame: Pre-operative, 3 or 6 months, 1 year, 2 year and 5 year ]
    Assessment of improvement of clinical outcomes following total hip replacement surgery using the Harris Hip Scores

  2. Change from baseline of implant survivorship [ Time Frame: Post-operative 3 or 6 months, 1 year, 2 year, and 5 year ]
    Assessment of bone fracture, implant fracture, neck reabsorption

  3. Change in baseline of Complications [ Time Frame: Day of surgery, post-operative 3 or 6 months, 1 year, 2 year, and 5 year. ]
    Assessment of Adverse events and serious adverse events

  4. Change in baseline fixation and wear [ Time Frame: Post-operative 3 or 6 months, 1 year, 2 year and 5 year ]
    Radiographic analysis by measuring Radio Lucent Lines

  5. Change in baseline fixation [ Time Frame: Post-operative 3 or 6 months, 1 year, 2 year and 5 year ]
    Radiographic analysis by measuring implant fixation in millimeters



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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): NCT03897595


Contacts
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Contact: Mukesh Ahuja, CPI, MBBS, MS 312-548-9968 mahuja@medacta.us.com

Locations
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United States, Colorado
Denver Vail Orthopedics Recruiting
Parker, Colorado, United States, 80134
Contact: Derek Johnson, MD    303-925-4750    derek@webproze.com   
United States, Idaho
Saint Alphonsus Medical Group Recruiting
Boise, Idaho, United States, 83706
Contact: Dennis McGee, MD    208-367-3330      
Principal Investigator: Dennis McGee, MD         
United States, Illinois
Illinois Bone and Joint Institute Recruiting
Libertyville, Illinois, United States, 60048
Contact: Peter Thadani, MD    847-247-4000    pthadani@ibji.com   
United States, Oklahoma
McBride Orthopedic Hospital Recruiting
Oklahoma City, Oklahoma, United States, 73103
Contact: Thomas Tkach, MD    405-230-9270    tomtkach3@gmail.com   
United States, Utah
Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence Recruiting
West Jordan, Utah, United States, 84088
Contact: Charles Marshall, MD         
Sponsors and Collaborators
Medacta USA

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Responsible Party: Medacta USA
ClinicalTrials.gov Identifier: NCT03897595     History of Changes
Other Study ID Numbers: P01.014.08/01
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Osteoarthritis, Hip
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases