EU Safety and Efficacy Study Regarding the R3 Acetabular Hip System

NCT04399928 | Completed Results

• 1 other identifier: SR 16-4845-15 (R11019)
• Study Type: observational
• Target: 479
• Locations: 7 countries
• Sites: 8

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.

Conditions

Degenerative Joint Disease

Keywords

Degenerative joint disease; Total Hip Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 10 years post-operatively

Secondary Outcomes (7)

• 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

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

  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

  Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years

• Radiographic Findings: Atrophy

  1 years, 3 years, 5 years, 7 years, 10 years

• Radiographic Findings: Hypertrophy

  1 years, 3 years, 5 years, 7 years, 10 years

Interventions

Total Hip Arthroplasty DEVICE

Total hip arthroplasty with the R3 Acetabular Hip system.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This clinical study can fulfill its objectives only if appropriate subjects are enrolled. All relevant medical and non-medical conditions should be taken into consideration when deciding whether a particular patient is suitable. Subjects will be enrolled consecutively.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Smith & Nephew Orthopaedics AG: lead

Study Sites (8)

AZ Nikolaas

Sint-Niklaas, Moerlandstraat 1, 9100, Belgium

Location

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

Helsinki University Hospital

Helsinki, FI-00029, Finland

Location

TYKS Turku University Hospital

Turku, 20880, Finland

Location

Knappschaftskrankenhaus Püttlingen

Püttlingen, 66346, Germany

Location

Medisch Centrum Alkmaar

Alkmaar, 1815 JD, Netherlands

Location

University Hospital La Paz

Madrid, 28046, Spain

Location

The Royal Orthopaedic Hospital, NHS Foundation Trust

Birmingham, B 31 2AP, United Kingdom

Location

MeSH Terms

Conditions

Joint Diseases

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Results Point of Contact

• Title: Fleur Derdeyn, Clinical Study Manager
• Organization: Smith & Nephew

fleur.derdeyn@smith-nephew.com

+32497602032

Study Officials

• Remes, Associate Professor

  University of Helsinki

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 22, 2020
• Study Start: May 18, 2009
• Primary Completion: February 18, 2022
• Study Completion: April 1, 2022
• Last Updated: April 11, 2025
• Results First Posted: April 11, 2025

Record last verified: 2022-05

Locations

DK (1); NL (1); ES (1); BE (1); GB (1); FI (2); DE (1)