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

Terminated

• Conditions: Complications Arthroplasty
• Interventions: Device: revision multihole acetabular cup

• Registration Number: NCT03031964
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-20
• Study First Submitted QC: 2017-01-25
• Study First Posted: 2017-01-26
• Status Verified: 2022-01
• Primary Completion: 2022-01
• Study Completion: 2022-01
• Last Update Submitted: 2022-01-14
• Last Update Posted: 2022-01-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
revision multihole acetabular cup	revision multihole acetabular cup	Revision total hip arthroplasty using multihole revision acetabular cup

Primary Outcome Measures

Name	Time	Method
survivorship of a multihole revision acetabular cup	10 years	evaluate standard of care radiographs for any signs of implant compromise such as loosening or osteolysis

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States