Survivorship, Radiographic, and Functional Outcomes of the Multihole Revision Acetabular Cup

January 14, 2022 updated by: Carlos Higuera-Rueda, The Cleveland Clinic

Survivorship, Clinical and Functional Outcomes of the Multihole Revision Acetabular Cup

This study will evaluate patients receiving a multihole revision acetabular implant for total hip arthroplasty (THA) and will be followed for 10 years to collect data on survivorship of the implanted prosthesis.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Data will be collected preoperatively, and at the standard of care (SOC) office visits at 4 weeks, 1 year, 2 years, 5 years and 10 years postoperatively. The research coordinator at each site will identify, recruit, and prospectively follow the 60 patients at his/her site. Patient demographics (e.g., age, gender, body mass index (BMI)), comorbidities, reason for revision, Paprosky classification, native femoral head measurement (mm) etc. will be collected preoperatively. The study coordinator will contact patients prior to each visit to ensure patient compliance. At each visit, A-P and cross-lateral radiographic evaluation (i.e., use of Engh classification to quantify osteolysis/loosening) will occur. In addition, patients will be assessed for any complications (e.g., dislocation, emergency department visits, infection, reoperation, etc.). Patients will complete the Hip disability and Osteoarthritis Outcome Score (HOOS) and Veterans Rand 12 (VR-12) forms (including a specific question regarding groin pain) and a pain assessment. In the event that a patient has relocated and/or refuses to return to the office for the 5-year visit, a script will be sent to the patient to have x-rays done and sent to the PI, and questionnaires will be mailed. All data will be entered and maintained in RedCap.

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients requiring a revision total hip arthroplasty

Description

Inclusion Criteria:

  1. Patients requiring revision total hip replacement of the acetabular component or complicated primary total hip replacement.
  2. Femoral stem (either retained or replaced) is a compatible Stryker stem.
  3. Patient is willing to comply with follow-up requirements (e.g. will return for long-term follow-up visits)
  4. Age: 18-85 years

Exclusion Criteria:

  1. Patient has a BMI > 40
  2. Exclude revision for infection
  3. Patient is undergoing bilateral THA surgery or had prior hip arthroplasty on contralateral side less than 6 months from date of surgery
  4. Patient has history of radiation therapy
  5. Patient has known diagnosis of renal disease
  6. Patient has known diagnosis of osteoporosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
revision multihole acetabular cup
Revision total hip arthroplasty using multihole revision acetabular cup
Device: revision multihole acetabular cup
post market study of multi hole revision acetabular cup
Other Names:
  • Stryker restoration anatomic shell

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survivorship of a multihole revision acetabular cup
Time Frame: 10 years
evaluate standard of care radiographs for any signs of implant compromise such as loosening or osteolysis
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcomes of multihole revision acetabular cup
Time Frame: 10 years
determine clinical outcomes with VR-12 surveys
10 years
functional outcomes of multihole revision acetabular cup
Time Frame: 10 years
determine functional outcomes with HOOS surveys
10 years
assess pain levels in patients who receive multihole revision acetabular cup
Time Frame: 10 years
determine level of pain with pain assessments
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Carlos Higuera, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

January 25, 2017

First Posted (Estimate)

January 26, 2017

Study Record Updates

Last Update Posted (Actual)

January 28, 2022

Last Update Submitted That Met QC Criteria

January 14, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • #16-1030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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