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

Completed

Brief 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.

Detailed 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 & 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)

Primary Outcome Measures

Name	Time	Method
Implant Survivorship	10 Years	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').

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Radiographic Success	3-years, 5-years, 7-years 10-years	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
Modified Harris Hip Score (mHHS)	Pre-operative, 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.

Locations (5): AZ Nikolaas
🇧🇪
Sint-Niklaas, Belgium
TYKS Turku University Hospital
🇫🇮
Turku, Finland
HUS Peijaksen sairaala, Ortopedia ja traumatologia
🇫🇮
Helsinki, Finland
The Royal Orthopaedic Hospital, NHS Foundation Trust
🇬🇧
Birmingham, United Kingdom
La Paz Hospital
🇪🇸
Madrid, Spain