Clinical trial NCT04399928: EU Safety and Efficacy Study Regarding the R3 Acetabular Hip System
Official title: A Prospective, Multicenter, Non-randomized, Clinical Outcomes Study of the R3◊ Acetabular System in Patients With Degenerative Hip Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Joint Disease
Keywords: Degenerative joint disease
Total Hip Arthroplasty
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2020-05-22
Enrollment: 479
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. Subjects will be enrolled consecutively.

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.

Detailed description: This is a multicenter prospective observational post-market clinical follow-up study that will include 500 patients who will have total hip replacement with the R3 Acetabular System and either cemented or cementless hip stem.

Effectiveness will be assessed by comparison of changes in parameters contained in the HOOS questionnaire and based upon incidence of revision and change in Harris Hip Score and UCLA Rating. Safety will be measured by assessing all adverse events experienced by patients from study enrolment through to study completion.

Eligibility criteria: Inclusion Criteria:

Subjects must meet all of the following characteristics for inclusion in the study.

* 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

Exclusion Criteria:

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)

Primary outcomes:
measure: Implant Survivorship
timeFrame: up to 10 years post-operatively
Secondary outcomes:
measure: Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS)
timeFrame: Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years
measure: Patient Reported Outcome (PRO): Modified Harris Hip Score (mHHS)
timeFrame: Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years
measure: Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) Rating
timeFrame: Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years
measure: Radiographic Findings: Atrophy
timeFrame: 1 years, 3 years, 5 years, 7 years, 10 years
measure: Radiographic Findings: Hypertrophy
timeFrame: 1 years, 3 years, 5 years, 7 years, 10 years
measure: Radiographic Findings: Osteolysis
timeFrame: 1 years, 3 years, 5 years, 7 years, 10 years
measure: Radiographic Findings: Radiolucent Lines (RLL)
timeFrame: 1 years, 3 years, 5 years, 7 years, 10 years
Other outcomes:
Locations:
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
state: Moerlandstraat 1
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Turku
country: Finland
facility: TYKS Turku University Hospital
city: Püttlingen
country: Germany
facility: Knappschaftskrankenhaus Püttlingen
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar
city: Madrid
country: Spain
facility: University Hospital La Paz
city: Birmingham
country: United Kingdom
facility: The Royal Orthopaedic Hospital, NHS Foundation Trust
Study officials:
affiliation: University of Helsinki
name: Remes, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References: