Clinical trial NCT03031964: Survivorship, Radiographic, and Functional Outcomes of the Multihole Revision Acetabular Cup
Official title: Survivorship, Clinical and Functional Outcomes of the Multihole Revision Acetabular Cup
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Complications Arthroplasty
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring a revision total hip arthroplasty

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.

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.

Eligibility 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

Primary outcomes:
measure: survivorship of a multihole revision acetabular cup
timeFrame: 10 years
Secondary outcomes:
measure: Clinical outcomes of multihole revision acetabular cup
timeFrame: 10 years
measure: functional outcomes of multihole revision acetabular cup
timeFrame: 10 years
measure: assess pain levels in patients who receive multihole revision acetabular cup
timeFrame: 10 years
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Carlos Higuera, MD
role: PRINCIPAL_INVESTIGATOR
References:
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