Clinical Trials Directory

Trials / Unknown

UnknownNCT03986918

Survivorship and Patient Outcomes of Primary Total Hip Arthroplasty With the Ovation Hip System

Status
Unknown
Phase
—
Study type
Observational
Enrollment
400 (estimated)
Sponsor
Ortho Development Corporation · Industry
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

The objective of this study is to evaluate patient outcomes in regards to safety and effectiveness based on the clinical performance of the reference devices to further support the assessment of residual risk identified in the Clinical Evaluation Report for the Ortho Development Hip System.

Detailed description

Long term surveillance of survivorship and complications can help to identify pre-surgical comorbidities, perhaps leading to a lower risk of implant failure and subsequent revision surgery. By understanding the role of comorbidities in the specific population, it is possible to increase patient outcomes and satisfaction, while reducing the costs associated with complications and revision surgeries. This study consists of prospective collection and analysis of data for a consecutive series of patients that underwent total hip arthroplasty with the Ortho Development Ovation® Hip System at the study site between 2012 and December 2015. It is estimated that over 400 patients received the subject system. Each of these patients will receive a survey within the mail when they approach, or have exceeded, their five-year post-surgical time period.

Conditions

Interventions

TypeNameDescription
DEVICERoutine Total Hip ArthroplastyPatients undergoing routine total hip arthroplasty will receive surveys regarding survivorship and outcomes.

Timeline

Start date
2019-06-01
Primary completion
2023-06-30
Completion
2024-06-30
First posted
2019-06-14
Last updated
2019-06-14

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03986918. Inclusion in this directory is not an endorsement.