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

Completed
Conditions
Hip Osteoarthritis
Registration Number
NCT03897595
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
187
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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

Change from baseline of implant survivorshipPost-operative 3 or 6 months, 1 year, 2 year, and 5 year

Assessment of bone fracture, implant fracture, neck reabsorption

Change in baseline of ComplicationsDay of surgery, post-operative 3 or 6 months, 1 year, 2 year, and 5 year.

Assessment of Adverse events and serious adverse events

Change in baseline fixation and wearPost-operative 3 or 6 months, 1 year, 2 year and 5 year

Radiographic analysis by measuring Radio Lucent Lines

Change in baseline fixationPost-operative 3 or 6 months, 1 year, 2 year and 5 year

Radiographic analysis by measuring implant fixation in millimeters

Secondary Outcome Measures
NameTimeMethod

Trial Locations

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

Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence

🇺🇸

West Jordan, Utah, United States

Denver Vail Orthopedics
🇺🇸Parker, Colorado, United States

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