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

NCT03897595 | Completed FDA Device

• 1 other identifier: P01.014.08/01
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (5)

• Change from baseline Harris Hip Scores (HHS)

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

  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

  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

  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

  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

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

Study Arms (1)

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: MPact Cup

Interventions

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

Mpact cup

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study.

Sponsors & Collaborators

• Medacta USA: lead

Study Sites (5)

Denver Vail Orthopedics

Parker, Colorado, 80134, United States

Location

Saint Alphonsus Medical Group

Boise, Idaho, 83706, United States

Location

Illinois Bone and Joint Institute

Libertyville, Illinois, 60048, United States

Location

McBride Orthopedic Hospital

Oklahoma City, Oklahoma, 73103, United States

Location

Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence

West Jordan, Utah, 84088, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: April 1, 2019
• Study Start: October 1, 2012
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

US (5)