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OpenTrials
Completed

NCT Number: NCT03897595

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

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

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Key information

Conditions

Hip Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Denver Vail Orthopedics, Parker, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MPact Cup

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Medacta USA

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2019
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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