This is a prospective observational multi-center non-controlled study. The primary purpose of this study is to evaluate the clinical and radiographic performance of the G7 Acetabular Cup System.
This is a prospective observational multi-center non-controlled study. The primary purpose of this study is to evaluate the clinical and radiographic performance of the G7 Acetabular Cup System in both primary and revision procedures, report safety and survivorship, and document instrument ease of use. Preoperative and intraoperative data have been collected retrospectively and follow ups have been collected prospectively. Clinical outcomes included the Harris Hip Score, Oxford Hip Score, and Radiographic Evaluations collected at 3 month, 1, 2 and 5 year follow-up time points. For the 7 and 10 year follow-up intervals, survivorship and adverse events have been collected.
Study Type
OBSERVATIONAL
Enrollment
162
G7 Acetabular Cup System with Metal head on Polyethylene liner articulation (MOP)
G7 Acetabular Cup System with Ceramic head on Polyethylene liner articulation (COP)
G7 Acetabular Cup System with Ceramic head on Ceramic linear articulation (COC) - Outside the United States ONLY
University Orthopedic Specialists
Tucson, Arizona, United States
Clermont-Ferrand Hospital
Clermont-Ferrand, France
University of Würzburg, Orthopedic
Würzburg, Germany
Midwestern Regional Orthopaedic Hospital
Limerick, Ireland
Harris Hip Score
The Harris Hip Scale (HHS) is an outcome measure that includes a series of questions answered by the patient and physical examinations recorded by a qualified health care professional. The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, o-5 points). To obtain a final score, the points are summed. The outcome score can be categorized as Excellent:90 - 100; Good: 80 - 90; Fair: 70 - 80; Poor: \< 70.
Time frame: Pre-operative,1, 2, and 5 years postoperatively
Oxford Hip Score
The Oxford Hip Score (OHS) is a patient-reported outcome measure that was developed to specifically assess the patient's perspective of outcome following THA. The OHS consists of twelve questions covering function and pain associated with the hip. To calculate the total score, each response is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as Excellent: \> 41; Good: 34 - 41; Fair: 27 - 33; Poor: \< 27.
Time frame: Pre-op, 1, 2, and 5 years postoperatively
Survivorship
Fraction of patients without a revision of any of the hip implant component, calculated with the Kaplan Meier (K-M) estimate.
Time frame: 7 and 10 Year post-operative
Survivorship
Fraction of patients without a revision of any of the hip implant component, calculated with the Kaplan Meier (K-M) estimate.
Time frame: 10 Year post-operative
Radiographic Evaluation
All radiographs have been reviewed by the investigators at each site in order to detect and report any abnormal and significant findings (including adverse events). The change from the angle of inclination between the different follow-ups is shown in the table.
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Reinier de Graaf Groep
Delft, Netherlands
Hospital El Bierzo
Ponferrada, Spain
Time frame: Immediate post-op, 3 months, 1, 2, and 5 years