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

Smith & Nephew Orthopaedics AG135 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

135

Conditions

Degenerative Joint Disease of Hip

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

Locations (5)

AZ Nikolaas

Sint-Niklaas, Belgium

HUS Peijaksen sairaala, Ortopedia ja traumatologia

Helsinki, Finland

TYKS Turku University Hospital

Turku, Finland

La Paz Hospital

Madrid, Spain

Outcomes

Primary Outcomes

Implant Survivorship

Number of participants hip implant survivorship with implant survival defined as no revision through 10 years (i.e., 'Hip Survived' or 'Hip Did Not Survive').

Time frame: 10 Years

Secondary Outcomes

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-years, 5-years, 7-years, 10-years

Number of Participants With Radiographic Success

Count of participants with radiographic success, where success is 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°) Participants who did not meet criteria specified above were considered radiographic failures

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.