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

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.

Study Overview

• Status: Recruiting
• Conditions: Joint Diseases; Rheumatoid Arthritis; Osteoarthritis, Hip; Psoriatic Arthritis; Avascular Necrosis of Hip
• Intervention / Treatment: Device: Routine Total Hip Arthroplasty

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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Samantha Andrews, PhD; Phone Number: 8085224822; Email: samantha.andrews@straub.net

Study Locations

• United States
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Recruiting
      • Straub Medical Center
      • Contact: Samantha Andrews, PhD; Phone Number: 808-522-4855; Email: samantha.andrews@straub.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Identification will occur from a list of patients having undergone total hip arthroplasty at Straub Medical Center between 2012 and the end of December 2015. Identified patients will then be screened for eligibility criteria

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Routine Total Hip Arthroplasty; Patients undergoing routine total hip arthroplasty will receive surveys regarding survivorship and outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Ortho Development Corporation
• Investigators: Principal Investigator: Cass Nakasone, MD, Hawai'i Pacific Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2019
• Primary Completion (ANTICIPATED): June 30, 2023
• Study Completion (ANTICIPATED): June 30, 2024

Study Registration Dates

• First Submitted: June 7, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (ACTUAL): June 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2019
• Last Update Submitted That Met QC Criteria: June 13, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Osteoarthritis; Psoriasis; Arthritis; Joint Diseases; Necrosis; Arthritis, Psoriatic; Osteoarthritis, Hip
• Other Study ID Numbers: P-17-0013B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No