Clinical trial NCT03566082: Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - Europe
Official title: Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - Europe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Joint Disease of Hip
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
Collaborators: name: eResearchTechnology, Inc
name: M Squared Associates, Inc.
name: ExecuPharm PAREXEL
name: Iqvia Pty Ltd
First posted: 2018-06-21
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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 outcomes:
measure: Implant Survivorship
timeFrame: 10 Years
Secondary outcomes:
measure: Modified Harris Hip Score (mHHS)
timeFrame: Pre-operative, 3-years, 5-years, 7-years, 10-years
measure: Number of Participants With Radiographic Success
timeFrame: 3-years, 5-years, 7-years 10-years
Other outcomes:
Locations:
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
city: Helsinki
country: Finland
facility: HUS Peijaksen sairaala, Ortopedia ja traumatologia
city: Turku
country: Finland
facility: TYKS Turku University Hospital
city: Madrid
country: Spain
facility: La Paz Hospital
city: Birmingham
country: United Kingdom
facility: The Royal Orthopaedic Hospital, NHS Foundation Trust
Study officials:
References:
citation: Davis ET, Remes V, Virolainen P, Gebuhr P, Van Backle B, Revell MP, Kopjar B. Mid-term outcomes of the R3 delta ceramic acetabular system in total hip arthroplasty. J Orthop Surg Res. 2021 Jan 9;16(1):35. doi: 10.1186/s13018-020-02192-6.