Study Stopped
Study was closed mainly because the surgeons participating no longer had the infrastructure to support the research and weren't following their subjects
A Multi-centre, Prospective Surveillance to Assess Mid-term Performance of the Mpact Cup
A Multi-centre, Prospective Post Marketing Surveillance Study to Assess Mid-term Performance of the Mpact Cup in Subjects Requiring Primary Total Hip Arthroplasty
1 other identifier
observational
200
1 country
4
Brief Summary
This is a multi-centre, prospective post marketing surveillance study to assess mid-term performance of the Mpact cup in subjects requiring primary total hip arthroplasty.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2013
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 7, 2014
CompletedFirst Posted
Study publicly available on registry
July 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedMarch 22, 2023
March 1, 2023
8.1 years
July 7, 2014
March 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
The Kaplan-Meier analysis as a measure of implant performance.
5 years
Secondary Outcomes (2)
The Harris Hip Score.
pre-op, 3/6 months, 1,2 and 5 years
Radiological analysis as a meausure of safety.
3/6 months, 1,2 and 5 years
Study Arms (1)
Mpact Acetabular Shell
Monitor the performance of the Mpact cup in the treatment of patients with hip joint disease requiring a total hip replacement.
Interventions
Eligibility Criteria
primary total hip arthroplasty
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Vail Orthopedics, P.C.
Denver, Colorado, 80230, United States
Saint Alphonsus Regional Medical Center
Boise, Idaho, 83702, United States
Illinois Bone & Joint Institute, LLC
Libertyville, Illinois, 60048, United States
Jordan Valley Medical Center
West Jordan, Utah, 84088, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2014
First Posted
July 22, 2014
Study Start
March 1, 2013
Primary Completion
April 1, 2021
Study Completion
April 1, 2022
Last Updated
March 22, 2023
Record last verified: 2023-03