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

Sponsor
Medacta USA (Industry)
Overall Status
Completed
CT.gov ID
NCT03897595
Collaborator
(none)
187
Enrollment
5
Locations
1
Arm
113.9
Actual Duration (Months)
37.4
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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
  • 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
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
187 participants
Allocation:
N/A
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 HeadQuadra®-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 :
Oct 1, 2012
Actual Primary Completion Date :
Mar 30, 2022
Actual Study Completion Date :
Mar 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: 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 Names:
  • Hip replacement

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline Harris Hip Scores (HHS) [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 [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 [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 [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 [Post-operative 3 or 6 months, 1 year, 2 year and 5 year]

      Radiographic analysis by measuring implant fixation in millimeters

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Denver Vail Orthopedics Parker Colorado United States 80134
    2 Saint Alphonsus Medical Group Boise Idaho United States 83706
    3 Illinois Bone and Joint Institute Libertyville Illinois United States 60048
    4 McBride Orthopedic Hospital Oklahoma City Oklahoma United States 73103
    5 Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence West Jordan Utah United States 84088

    Sponsors and Collaborators

    • Medacta USA

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medacta USA
    ClinicalTrials.gov Identifier:
    NCT03897595
    Other Study ID Numbers:
    • P01.014.08/01
    First Posted:
    Apr 1, 2019
    Last Update Posted:
    Apr 1, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Osteoarthritis, Hip

    Study Results

    No Results Posted as of Apr 1, 2022