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

Medacta USA187 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

187

Conditions

Hip Osteoarthritis

Interventions

MPact CupDEVICE

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

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (5)

Denver Vail Orthopedics

Parker, Colorado, United States

Saint Alphonsus Medical Group

Boise, Idaho, United States

Illinois Bone and Joint Institute

Libertyville, Illinois, United States

McBride Orthopedic Hospital

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

Change from baseline Harris Hip Scores (HHS)

Assessment of improvement of clinical outcomes following total hip replacement surgery using the Harris Hip Scores

Time frame: Pre-operative, 3 or 6 months, 1 year, 2 year and 5 year

Change from baseline of implant survivorship

Assessment of bone fracture, implant fracture, neck reabsorption

Time frame: Post-operative 3 or 6 months, 1 year, 2 year, and 5 year

Change in baseline of Complications

Assessment of Adverse events and serious adverse events

Time frame: Day of surgery, post-operative 3 or 6 months, 1 year, 2 year, and 5 year.

Change in baseline fixation and wear

Radiographic analysis by measuring Radio Lucent Lines

Time frame: Post-operative 3 or 6 months, 1 year, 2 year and 5 year

Change in baseline fixation

Radiographic analysis by measuring implant fixation in millimeters

Time frame: Post-operative 3 or 6 months, 1 year, 2 year and 5 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.