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

NCT03986918 | Unknown FDA Device

• 1 other identifier: P-17-0013B
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pain and Function

  5 - 10 year follow-up

• General Health

  5 - 10 year follow-up

• Patient satisfaction.

  5 - 10 year follow-up

Study Arms (1)

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

Interventions

Routine Total Hip Arthroplasty DEVICE

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

Ovation and Ovation Tribute

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ortho Development Corporation: lead

Study Sites (1)

Straub Medical Center

Honolulu, Hawaii, 96813, United States

RECRUITING

MeSH Terms

Conditions

Joint Diseases; Osteoarthritis, Hip; Arthritis, Rheumatoid; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Osteoarthritis; Arthritis; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Study Officials

• Cass Nakasone, MD

  Hawai'i Pacific Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Andrews, PhD

CONTACT

8085224822; samantha.andrews@straub.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 14, 2019
• Study Start: June 1, 2019
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2024
• Last Updated: June 14, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)