The main objectives of this study are to confirm the long-term safety, performance and clinical benefits the Avenir Complete femoral stem and its instrumentation when used in primary total, hemi, and revision hip arthroplasty.
The main objectives of this study are to confirm the long-term safety, performance and clinical benefits the Avenir Complete™ femoral stem and its instrumentation when used in primary total, hemi, and revision hip arthroplasty: The primary endpoint is defined by the survival of the implant system at 10 years, which is based on the removal or intended removal of the "study device and determined using Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. The secondary endpoints are the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs) as well as radiographic outcomes (if available).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
275
All enrolled subjects will receive the Avenir Complete Femoral Stem
Mississippi Sports Medicine and Orthopaedic Center PLLC
Jackson, Mississippi, United States
Heartland Regional Medical Center d.b.a. Mosaic Life Care
Saint Joseph, Missouri, United States
Orthopedic & Fracture Clinic, PC
Portland, Oregon, United States
Survival of the study device; whether or not it is still implanted in the subject
Survival is classified as removal of the study device for any reason
Time frame: 10 years
Incidence of treatment-emergent Adverse Events (safety)
Safety is assessed by monitoring the frequency and incidence of all adverse events, with particular focus on those that may be related to the study device.
Time frame: 10 years
Harris Hip Score
Functional outcomes are measured with the Harris Hip Score, including range of motion, pain level, activity levels and patient satisfaction. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).
Time frame: 3 years
Patient Quality of Life
This is another self-assessment by means of the EQ-5D-5L (EuroQol) score, which measures the patient's perceived quality of life. EQ VAS: Score between 0 and 100 recorded by an individual, 100 being the highest. EQ 5D Value: "The value attached to an EQ-5D profile according to a set of weights that reflect, on average, people's preferences about how good or bad the state is. Values are anchored at 1 (full health) and 0 (a state as bad as being dead)" https://euroqol.org/support/terminology/
Time frame: 10 years
Radiographic analysis
Postoperative radiographs will be analyzed by the Investigator
Time frame: 10 years
Oxford Hip Score
The Oxford Hip Score (OHS) is a joint-specific, patient-reported outcome measure tool designed to assess disability in patients undergoing total hip replacement. The score is measured on a scale of 0 to 48 with 48 being the best outcome.
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Copenhagen University Hospital, Hvidovre
Copenhagen, Denmark
Nissan Tamagawa Hospital
Setagaya-Ku, Tokyo, Japan
Okayama City Hospital
Okayama, Japan
Ikazia Ziekenhuis
Rotterdam, South Holland, Netherlands
Sykehuset Innlandet HF
Tynset, Norway
Sahlgrenska University Hospital - Molndal
Mölndal, Sweden
Time frame: 10 years