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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03986918
• Other study ID #: P-17-0013B
• Status: Recruiting
• Start date: June 1, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2019
• Source: Ortho Development Corporation
• Contact: Samantha Andrews, PhD
• Phone: 8085224822
• Email: samantha.andrews[@]straub.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Routine Total Hip Arthroplasty
Patients undergoing routine total hip arthroplasty will receive surveys regarding survivorship and outcomes.

Locations

Country	Name	City	State
United States	Straub Medical Center	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
Ortho Development Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survivorship - The number of revision surgeries over time.	The primary outcome will be 5-10 year survivorship of implant components, with failure defined as revision of any component.	5 - 10-year follow-up
Secondary	Pain and Function	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.	5 - 10 year follow-up
Secondary	General Health	The Veterans Rand - 12 (VR-12) will be used to measure general health, including the ability to carry out usual activities.	5 - 10 year follow-up
Secondary	Patient satisfaction.	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.	5 - 10 year follow-up