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

Completed

• Conditions: Hip Osteoarthritis
• Interventions: Device: MPact Cup

• 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

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-28
• Study First Posted: 2019-04-01
• Primary Completion: 2022-03-30
• Study Completion: 2022-03-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-15
• Last Update Posted: 2023-06-18

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

Arm && Interventions

Group	Intervention	Description
Mpact cup	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

Primary Outcome Measures

Name	Time	Method
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 survivorship	Post-operative 3 or 6 months, 1 year, 2 year, and 5 year	Assessment of bone fracture, implant fracture, neck reabsorption
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
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
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

Trial Locations

Locations (5)

McBride Orthopedic Hospital; 🇺🇸 Oklahoma City, Oklahoma, United States

Denver Vail Orthopedics; 🇺🇸 Parker, Colorado, United States

Illinois Bone and Joint Institute; 🇺🇸 Libertyville, Illinois, United States

Saint Alphonsus Medical Group; 🇺🇸 Boise, Idaho, United States

Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence; 🇺🇸 West Jordan, Utah, United States