EU Safety and Efficacy Study Regarding the R3 Acetabular Hip System

Completed

Conditions: Degenerative Joint Disease

Registration Number: NCT04399928

Lead Sponsor: Smith & Nephew Orthopaedics AG

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 479

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)

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implant Survivorship	up to 10 years post-operatively	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.

Secondary Outcome Measures

Name	Time	Method
Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS)	Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years	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).
Patient Reported Outcome (PRO): Modified Harris Hip Score (mHHS)	Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years	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.
Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) Rating	Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years	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).
Radiographic Findings: Atrophy	1 years, 3 years, 5 years, 7 years, 10 years	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
Radiographic Findings: Hypertrophy	1 years, 3 years, 5 years, 7 years, 10 years	Number of participant hips with radiographic findings for hypertrophy 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: * Hypertrophy in any Cup Zones * Hypertrophy in any Stem Zones
Radiographic Findings: Osteolysis	1 years, 3 years, 5 years, 7 years, 10 years	Number of participant hips with radiographic findings for osteolysis greater than 2 millimeters in any cup or stem zones indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, \& 10 years as the following: * Osteolysis \> 2mm in any Cup Zones * Osteolysis \> 2mm in any Stem Zones
Radiographic Findings: Radiolucent Lines (RLL)	1 years, 3 years, 5 years, 7 years, 10 years	Number of participant hips with radiographic findings for radiolucent lines (RLL) greater than 2 millimeters in any cup or stem zones indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, \& 10 years as the following: * RLL \> 2mm in any Cup Zones * RLL \> 2mm in any Stem Zones

Trial Locations

Locations (8): AZ Nikolaas
🇧🇪
Sint-Niklaas, Moerlandstraat 1, Belgium
TYKS Turku University Hospital
🇫🇮
Turku, Finland
Knappschaftskrankenhaus Püttlingen
🇩🇪
Püttlingen, Germany
Medisch Centrum Alkmaar
🇳🇱
Alkmaar, Netherlands
Hvidovre University Hospital
🇩🇰
Hvidovre, Denmark
The Royal Orthopaedic Hospital, NHS Foundation Trust
🇬🇧
Birmingham, United Kingdom
University Hospital La Paz
🇪🇸
Madrid, Spain
Helsinki University Hospital
🇫🇮
Helsinki, Finland