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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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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

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Joint Diseases Osteoarthritis, Hip Rheumatoid Arthritis Psoriatic Arthritis Avascular Necrosis of Hip

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ovation and Ovation Tribute

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.

Routine Total Hip Arthroplasty

Intervention Type DEVICE

Patients undergoing routine total hip arthroplasty will receive surveys regarding survivorship and outcomes.

Interventions

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Routine Total Hip Arthroplasty

Patients undergoing routine total hip arthroplasty will receive surveys regarding survivorship and outcomes.

Intervention Type DEVICE

Eligibility Criteria

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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.