Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - Europe

Degenerative Joint Disease of Hip Clinical Trial

— R3 EU PAS  

Official title:

Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - Europe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03566082
• Other study ID #: R11019
• Status: Completed
• Start date: February 10, 2017
• Est. completion date: October 15, 2021

Study information

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

Clinical Trial Summary

The purpose of this prospective, multicenter, single arm study is to confirm the long-term safety and effectiveness of the R3 delta Ceramic Acetabular System PMA (P150030) by evaluating long-term (10 years after surgery) follow-up results.

Description:

This PAS is a long-term follow-up of the R3 delta Ceramic Acetabular System (DOD) hips enrolled in the study that was analyzed for the Premarket Approval Application (PMA) Study. The PMA Study analyzed 3 Year postoperative follow-up data on Biolox delta ceramic-on-Biolox delta ceramic (DOD) and Oxidized zirconium-on-Crosslinked Polyethylene (OxZr/XLPE) hips, enrolled and followed in a European Post-market Study ("A prospective, multicenter, non-randomized, clinical outcome study of the R3 Acetabular System in patients with degenerative hip disease"). The purpose of this prospective, multicenter, single arm study is to confirm the long-term safety and effectiveness of the R3 delta Ceramic Acetabular System PMA (P150030) by evaluating long-term (10 years after surgery) follow-up results. Hips are evaluated at the following intervals: 5, 7, 10 years postoperative. The primary study endpoint is implant survivorship at 10 years post surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: October 15, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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/ developmental dysplasia of the hip) 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: 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 of Hip
• Joint Diseases
• Osteoarthritis
• Osteoarthritis, Hip

Locations

Country	Name	City	State
Belgium	AZ Nikolaas	Sint-Niklaas
Finland	HUS Peijaksen sairaala, Ortopedia ja traumatologia	Helsinki
Finland	TYKS Turku University Hospital	Turku
Spain	La Paz Hospital	Madrid
United Kingdom	The Royal Orthopaedic Hospital, NHS Foundation Trust	Birmingham

Sponsors (5)

Lead Sponsor	Collaborator
Smith & Nephew Orthopaedics AG	eResearchTechnology, Inc, ExecuPharm PAREXEL, Iqvia Pty Ltd, M Squared Associates,Inc.

Countries where clinical trial is conducted

Belgium,  Finland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survivor rate	Did hip survive with no revision through 10 years	10 Years
Secondary	Modified Harris Hip Score	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
Secondary	Radiographic outcomes	radiographic success defined as: No radiolucencies greater than 2 mm in 50% or more in any of the cup or stem zones; and; No femoral or acetabular subsidence greater than or equal to 5mm from baseline; and; No acetabular cup inclination changes greater than 4 degrees (4°)	10 Years
Secondary	Adverse Events	All AEs will be collected and reported	10 Years