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

• Conditions: Osteoarthritis, Hip; Psoriatic Arthritis; Joint Diseases; Rheumatoid Arthritis; Avascular Necrosis of Hip
• Interventions: Device: Routine Total Hip Arthroplasty

• Registration Number: NCT03986918
• Lead Sponsor: Ortho Development Corporation

Brief 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.

Study Timeline

• Status Verified: 2019-06
• Study Start: 2019-06-01
• Study First Submitted: 2019-06-07
• Study First Submitted QC: 2019-06-13
• Last Update Submitted: 2019-06-13
• Study First Posted: 2019-06-14
• Last Update Posted: 2019-06-14
• Primary Completion: 2023-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ovation and Ovation Tribute	Routine Total Hip Arthroplasty	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.

Primary Outcome Measures

Name	Time	Method
Survivorship - The number of revision surgeries over time.	5 - 10-year follow-up	The primary outcome will be 5-10 year survivorship of implant components, with failure defined as revision of any component.

Secondary Outcome Measures

Name	Time	Method
General Health	5 - 10 year follow-up	The Veterans Rand - 12 (VR-12) will be used to measure general health, including the ability to carry out usual activities.
Patient satisfaction.	5 - 10 year follow-up	A four question patient satisfaction survey will be used to measure the patient's satisfaction with their surgery, pain control, function, and ability to participate in recreational activities.
Pain and Function	5 - 10 year follow-up	The Hip Disability and Osteoarthritis Outcome score - joint replacement (HOOS JR) will be used. The HOOS-JR is a joint replacement survey designed to measure pain and function.

Trial Locations

Locations (1)

Straub Medical Center; 🇺🇸 Honolulu, Hawaii, United States