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



Status:Recruiting
Healthy:No
Age Range:18 - 85
Updated:8/25/2018
Start Date:December 2016
End Date:October 2028
Contact:Carlos Higuera, MD
Email:higuerc@ccf.org
Phone:216-636-1136

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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.

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.

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
We found this trial at
1
site
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Phone: 216-444-4954
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