A Multi-centre, Prospective Surveillance to Assess Mid-term Performance of the Mpact Cup

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02196818
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Medacta International SA
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis, Arthritis, Avascular Necrosis, Fracture of the Femoral Neck or Head, Congenital Hip Dysplasia

Arms & Interventions

Arms

: 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

Device: - Mpact Acetabular Shell

Total Hip Replacement

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Vail Orthopedics, P.C., Denver, Colorado

Status

Recruiting

Address

Vail Orthopedics, P.C.

Denver, Colorado, 80230

Site Contact

Derek Johnson, MD

[email protected]

303-214-4500

Saint Alphonsus Regional Medical Center, Boise, Idaho

Status