Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03031964
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : October 30, 2020
Sponsor:
Information provided by (Responsible Party):
Carlos Higuera-Rueda, The Cleveland Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment
Complications Arthroplasty Device: revision multihole acetabular cup

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Survivorship, Clinical and Functional Outcomes of the Multihole Revision Acetabular Cup
Study Start Date : December 2016
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : October 2028

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 Name: Stryker restoration anatomic shell




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Clinical outcomes of multihole revision acetabular cup [ Time Frame: 10 years ]
    determine clinical outcomes with VR-12 surveys

  2. functional outcomes of multihole revision acetabular cup [ Time Frame: 10 years ]
    determine functional outcomes with HOOS surveys

  3. assess pain levels in patients who receive multihole revision acetabular cup [ Time Frame: 10 years ]
    determine level of pain with pain assessments



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients requiring a revision total hip arthroplasty
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031964


Contacts
Layout table for location contacts
Contact: Carlos Higuera, MD 216-636-1136 higuerc@ccf.org
Contact: Alison Klika, MS 216-444-4954 klikaa@ccf.org

Locations
Layout table for location information
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Alison Klika    216-444-4954    klikaa@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Layout table for investigator information
Principal Investigator: Carlos Higuera, MD The Cleveland Clinic
Publications:

Layout table for additonal information
Responsible Party: Carlos Higuera-Rueda, Staff Surgeon, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03031964    
Other Study ID Numbers: #16-1030
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No