EU Safety and Efficacy Study Regarding the R3 Acetabular Hip System

Smith & Nephew Orthopaedics AG479 enrolled

Overview

The objective of this study is to determine the long-term safety and effectiveness from the R3 Acetabular Hip System. The study hypothesis is that implant survivorship of the R3 cup is at least 97% at 3 years, 95% at 5 years, 93% at 7 years, and 90% at 10 years follow-up.

This is a multicenter prospective observational post-market clinical follow-up study that will include 500 patients who will have total hip replacement with the R3 Acetabular System and either cemented or cementless hip stem. Effectiveness will be assessed by comparison of changes in parameters contained in the HOOS questionnaire and based upon incidence of revision and change in Harris Hip Score and UCLA Rating. Safety will be measured by assessing all adverse events experienced by patients from study enrolment through to study completion.

Study Type

OBSERVATIONAL

Enrollment

479

Conditions

Degenerative Joint Disease

Interventions

Total Hip ArthroplastyDEVICE

Total hip arthroplasty with the R3 Acetabular Hip system.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: Subjects must meet all of the following characteristics for inclusion in the study. * Patient is 18-75 years old and he/she is skeletally mature * Patient requires primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis, post-traumatic arthritis, avascular necrosis, dysplasia/DDH or inflammatory joint disease (e.g., rheumatoid arthritis) * Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk * The patient is willing to comply the follow-up schedule Exclusion Criteria: Subjects with any of the following characteristics must be excluded from the participation in the study. * Patient has active infection or sepsis (treated or untreated) * Patient is a prisoner or has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the study including mental illness, mental retardation, linguistic insufficiencies (i.e. immigrants), or drug/alcohol abuse. * Patients with acute hip trauma (femoral neck fracture)

Locations (8)

AZ Nikolaas

Sint-Niklaas, Moerlandstraat 1, Belgium

Hvidovre University Hospital

Hvidovre, Denmark

Helsinki University Hospital

Helsinki, Finland

TYKS Turku University Hospital

Turku, Finland

Outcomes

Primary Outcomes

Implant Survivorship

Implant survivorship by 10 years post study procedure measured by Kaplan-Meier survival rate. Implant survival determined by no revision required for any reason. A revision is a surgical procedure of the study hip where one or more of the study components are removed and replaced with new implants.

Time frame: up to 10 years post-operatively

Secondary Outcomes

Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS)

HOOS is a measurement of function and outcomes of daily living that ranges from 0 to 100 where 0 indicated extreme symptoms (i.e., worse outcome) and 100 indicated no symptoms (i.e., better outcome).

Time frame: Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years

Patient Reported Outcome (PRO): Modified Harris Hip Score (mHHS)

The mHHS scoring assessment ranges from 0 (worst) to 100 (best). Scores assessed during the pre-operative, 3-year, 5-year, 7-year and 10-year visit.

Time frame: Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years

Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) Rating

UCLA Activity Score is a measure of physical activity levels in participants undergoing total joint arthroplasty. The scale ranges from 1 to 10 with higher scores indicating greater physical function (i.e., a better outcome).

Time frame: Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years

Radiographic Findings: Atrophy

Number of participant hips with radiographic findings for atrophy indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, \& 10 years for the following: * Atrophy in any Cup Zones * Atrophy in any Stem Zones

Time frame: 1 years, 3 years, 5 years, 7 years, 10 years

Data from ClinicalTrials.gov

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