The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Freedom Constrained Vivacit-E Acetabular Liners in primary and revision total hip arthroplasty.
The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Freedom Constrained Vivacit-E Acetabular Liners in primary and revision total hip arthroplasty. The primary endpoint is defined by the survival of the implant system at 10 years, which is based on removal of the study device and will be determined using the 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 the 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). The G7 Vivacit-E Freedom Constrained Liner is indicated for use (per IFU) as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
202
Primary and/or Revision total hip arthroplasty with the G7 Freedom Constrained Vivacit-E Liners
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Southern California
Los Angeles, California, United States
University of Florida Board of Trustees
Gainesville, Florida, United States
Survival of the study device
Survival (whether or not it is still implanted in the subject) determined using Kaplan Meier method.
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
Pain and Functional Performance - Modified Harris Hip Score
The Harris Hip Score evaluates hip function, pain, mobility and daily activity impairment after hip replacement surgery. The ten items in the Harris hip score consist of answer choices, awarded a number of points. There are four domains evaluated, as follows: * Pain - 1 item which scores between 0 and 44; * Function - 7 items, scores are between 0 and 47; * Deformity - 1 item which scores either 0 or 4; * Range of motion - 1 item which scores between 0 and 5. The overall score varies between 0 and 100, where scores closer to 0 are suggestive of impaired hip function and scores closer to 100 indicate positive outcome. There are four categories of hip function status: * \<70: poor hip status; * 70 - 79: fair hip status; * 80 - 89: good hip status; * 90 - 100: excellent hip status.
Time frame: 10 years
Pain and Functional Performance - Oxford Hip Score
"The Oxford Hip Score is patient-reported outcome instrument which contains 12 questions on activities of daily living that assess function and residual pain in patients undergoing total hip replacement surgery. Grading the Oxford Hip Score 0 to 19-May indicate severe hip arthritis... 20 to 29-May indicate moderate to severe hip arthritis... 30 to 39-May indicate mild to moderate hip arthritis... 40 to 48-May indicate satisfactory joint function..." Oxford Hip Score. (n.d.) Segen's Medical Dictionary. (2011). Retrieved August 19 2022 from https://medical-dictionary.thefreedictionary.com/Oxford+Hip+Score Each question is scored from 0 to 4 with 4 being the best outcome. This method, when summed, produces overall scores running from 0 to 48 with 48 being the best outcome. The overall score is reached by simply summing the scores received for individual questions. This results in a continuous score ranging from 0 (most severe symptoms) to 48 (least symptoms).
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Jersey City Medical Center, Inc
Livingston, New Jersey, United States
The Ohio State University
Columbus, Ohio, United States
TOA Research Foundation
Knoxville, Tennessee, United States
The University of Texas Health Science Center of Houston
Houston, Texas, United States
Medical City Plano
Plano, Texas, United States
University of Utah
Salt Lake City, Utah, United States
West Virginia University
Morgantown, West Virginia, United States
Time frame: 10 years
Euroqol Patient Quality of life measured at 2 years follow-up (EQ-5D-5L)
The EuroQol five dimensions questionnaire (EQ-5D-5L) is a five dimensional self-assessment that is comprised of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These five dimensions can be used to index a subject's health utility on a scale of 0 to 1, where 0 is death and 1 is perfect health. The scoring rule for EQ-5D permits scores less than 0, implying that some health states may be worse than death. Note: no VAS measures will be obtained if completed by phone interview.
Time frame: 10 Years
Radiographic Performance evaluating radiolucency at 5 years follow-up
X-rays will be evaluated for radiolucency lines to show the number of subjects with radiolucency. Radiolucency refers to structures that are less dense and permit the x-ray beam to pass through them. Radiolucent structures appear dark or black in the radiographic image.
Time frame: 5 Years
Radiographic Performance evaluating osteolysis at 5 years follow-up
X-rays will be evaluated for osteolysis to show the number of subjects with osteolysis. Osteolysis is a progressive condition where bone tissue is destroyed. In this process, bones lose minerals (mostly calcium), softens, degenerates and become weaker.
Time frame: 5 Years
Radiographic Performance evaluating atrophy/hypertrophy at 5 years follow-up
X-rays will be evaluated for muscular atrophy/hypertrophy. An increase in total mass of a muscle is referred to as as hypertrophy, whereas a decrease in total mass of a muscle is referred to as atrophy.
Time frame: 5 Years
Radiographic Performance evaluating component migration at 5 years follow-up
X-rays will be evaluated for component migration to show the number of subjects with migration. Component migration refers to the presence of the device component gradually moving anteriorly, posteriorly, superiorly, or inferiorly in relation to original placement.
Time frame: 5 Years
Radiographic Performance evaluating device fracture at 5 years follow-up
Radiographs will be evaluated (up to 5 years) for evidence of device fracture.
Time frame: 5 Years
Radiographic Performance evaluating heterotopic ossification at 5 years follow-up
X-rays will be evaluated for heterotopic ossification to show the number of subjects with heterotopic ossification. Heterotopic ossification refers to the presence of bone in soft tissue where bone normally does not exist (extraskeletal bone).
Time frame: 5 Years