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

Ortho Development

Status: Enrolling

Conditions: Avascular Necrosis of Hip; Osteoarthritis, Hip; Joint Diseases; Psoriatic Arthritis; Rheumatoid Arthritis

Treatments: Device: Routine Total Hip Arthroplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT03986918

P-17-0013B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is at least 18 years of age
• Patient is five years post total hip arthroplasty
• Patient received the Ovation® or Ovation Tribute® femoral stem with associated acetabular and femoral components
• Patient agrees to participate in the survey.

Exclusion criteria

• Patient does not have the Ovation® or Ovation Tribute® femoral stem with associated acetabular and femoral components

Trial design

400 participants in 1 patient group

Ovation and Ovation Tribute

Description:

All patients having undergone a total hip arthroplasty that received the Ovation® or Ovation Tribute® (Ortho Development, Draper, Utah) Hip system will be sent the survey.

Treatment:

Device: Routine Total Hip Arthroplasty