EU Safety and Efficacy Study Regarding the R3 Acetabular Hip System

Degenerative Joint Disease Clinical Trial

Official title:

A Prospective, Multicenter, Non-randomized, Clinical Outcomes Study of the R3◊ Acetabular System in Patients With Degenerative Hip Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04399928
• Other study ID #: SR 16-4845-15 (R11019)
• Status: Completed
• Start date: May 18, 2009
• Est. completion date: April 1, 2022

Study information

• Verified date: May 2022
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 512
• Est. completion date: April 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Degenerative Joint Disease
• Joint Diseases
• Osteoarthritis

Intervention

Device:
• Total Hip Arthroplasty
Total hip arthroplasty with the R3 Acetabular Hip system.

Locations

Country	Name	City	State
Belgium	AZ Nikolaas	Sint-Niklaas	Moerlandstraat 1
Denmark	Hvidovre University Hospital	Hvidovre
Finland	Helsinki University Hospital	Helsinki
Finland	TYKS Turku University Hospital	Turku
Germany	Knappschaftskrankenhaus Püttlingen	Püttlingen
Netherlands	Medisch Centrum Alkmaar	Alkmaar
Spain	University Hospital La Paz	Madrid
United Kingdom	The Royal Orthopaedic Hospital, NHS Foundation Trust	Birmingham

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew Orthopaedics AG

Countries where clinical trial is conducted

Belgium,  Denmark,  Finland,  Germany,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Revision for any reason	Implant survivorship at 10 years post study procedure. 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.	10 years post-op
Secondary	Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS)	The HOOS is developed as an instrument to assess the subject's opinion about their hip and associated problems. HOOS consists of 5 subscales: Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec), and hip related Quality of Life (QOL).; Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.	10 years post-op
Secondary	Patient Reported Outcome (PRO): modified Harris Hip Score (HHS)	Effectiveness assessed by comparison of changes in parameters from baseline through 10 year post. 2 subscales (8 items), Scores summed and normalized to 100, Excellent: 90 - 100 points Good: 80 - 89 points Fair: 70 - 79 points Poor: < 70 points.	10 years post-op
Secondary	Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) rating	UCLA Activity Score is a measure of physical activity levels in subjects undergoing total joint arthroplasty. The scale is from 1 - 10 with higher values indicating greater physical function.	10 years post-op
Secondary	Safety Assessment	Safety will be measured by assessing all adverse events experienced by patients up to study completion or termination.	10 years post-op