Back to resultsG7 Freedom Constrained Vivacit-E Liners
Primary Purpose
Osteoarthritis, Hip, Rheumatoid Arthritis, Non-Union Fracture
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Total Hip Arthroplasty with G7 Freedom Constrained Vivacit-E Liners
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Hip
Eligibility Criteria
Inclusion Criteria:
- Patient is 18 to 80 years of age, inclusive
- Patient is skeletally mature
Patient qualifies for unilateral total hip arthroplasty based on physical exam and medical history including at least one of the following:
- Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- High risk for dislocation
- Undergoing revision hip arthroplasty
- Correction of functional deformity
- In need of treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
- Patient is willing and able to complete scheduled follow-up evaluations as described in the protocol and Informed Consent
- Patient, or the patient's legally authorized representative, has participated in the Informed Consent process and is willing and able to sign an IRB approved informed consent
Exclusion Criteria:
- Patient is septic, has an active infection or has osteomyelitis at the affected joint
- Patient has significant osteoporosis as defined by treating surgeon
- Patient has metabolic disorder(s) which may impair bone formation
- Patient has osteomalacia
- Patient has distant foci of infections which may spread to the implant site
- Patient has rapid joint destruction, marked bone loss or bone resorption on pre-operative radiographs
- Patient underwent contralateral THA within 3 months of planned index procedure or has a contralateral THA planned within 3 months of the index procedure
- Patient is undergoing simultaneous bilateral THA
- Patient has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery.
- In the opinion of the investigator, patient has any concomitant disease which is likely to jeopardize the functioning or success of the implant
- Patient is known to be pregnant
The patient is in the vulnerable population group, such as
- a prisoner
- a known alcohol or drug abuser
- mentally incompetent or unable to understand what participation in this study entails
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Total Hip Arthroplasty Treatment Group
Arm Description
This study will enroll (implant) up to 202 hips in total according to the IFU and surgical technique. Of these, up to 135 will be revision hips and up to 67 will be primary hips. This is a dual cohort study (primary and revision); each subject will receive the G7 Acetabular System with the Freedom Constrained Vivacit-E bearing. To minimize potential bias and to maximize our ability to assess inter-site differences, each study site will target up to 27 primary hip arthroplasties and up to 54 revision hip arthroplasties (not exceed 81 implanted hips or 40% of total study population). Each site is encouraged to enroll (implant) both primary and revision subjects.
Outcomes
Primary Outcome Measures
Survival of the study device
Survival (whether or not it is still implanted in the subject) determined using Kaplan Meier method.
Secondary Outcome Measures
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.
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.
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).
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.
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.
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.
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.
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.
Radiographic Performance evaluating device fracture at 5 years follow-up
Radiographs will be evaluated (up to 5 years) for evidence of device fracture.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05587244
Brief Title
G7 Freedom Constrained Vivacit-E Liners
Official Title
Multicenter, Prospective Post-Market Clinical Follow-Up Study of the G7® Freedom Constrained Vivacit-E® Liners
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
December 2037 (Anticipated)
Study Completion Date
December 2038 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip, Rheumatoid Arthritis, Non-Union Fracture, Trochanteric Fractures, Femoral Neck Fractures, Avascular Necrosis, Dislocation, Hip
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multicenter, Prospective, Non-controlled, Non-randomized, Consecutive series of patients, two cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
202 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Total Hip Arthroplasty Treatment Group
Arm Type
Experimental
Arm Description
This study will enroll (implant) up to 202 hips in total according to the IFU and surgical technique. Of these, up to 135 will be revision hips and up to 67 will be primary hips. This is a dual cohort study (primary and revision); each subject will receive the G7 Acetabular System with the Freedom Constrained Vivacit-E bearing. To minimize potential bias and to maximize our ability to assess inter-site differences, each study site will target up to 27 primary hip arthroplasties and up to 54 revision hip arthroplasties (not exceed 81 implanted hips or 40% of total study population). Each site is encouraged to enroll (implant) both primary and revision subjects.
Intervention Type
Device
Intervention Name(s)
Total Hip Arthroplasty with G7 Freedom Constrained Vivacit-E Liners
Intervention Description
Primary and/or Revision total hip arthroplasty with the G7 Freedom Constrained Vivacit-E Liners
Primary Outcome Measure Information:
Title
Survival of the study device
Description
Survival (whether or not it is still implanted in the subject) determined using Kaplan Meier method.
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Incidence of treatment-emergent Adverse Events (safety)
Description
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
Title
Pain and Functional Performance - Modified Harris Hip Score
Description
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
Title
Pain and Functional Performance - Oxford Hip Score
Description
"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).
Time Frame
10 years
Title
Euroqol Patient Quality of life measured at 2 years follow-up (EQ-5D-5L)
Description
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
Title
Radiographic Performance evaluating radiolucency at 5 years follow-up
Description
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
Title
Radiographic Performance evaluating osteolysis at 5 years follow-up
Description
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
Title
Radiographic Performance evaluating atrophy/hypertrophy at 5 years follow-up
Description
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
Title
Radiographic Performance evaluating component migration at 5 years follow-up
Description
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
Title
Radiographic Performance evaluating device fracture at 5 years follow-up
Description
Radiographs will be evaluated (up to 5 years) for evidence of device fracture.
Time Frame
5 Years
Title
Radiographic Performance evaluating heterotopic ossification at 5 years follow-up
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is 18 to 80 years of age, inclusive
Patient is skeletally mature
Patient qualifies for unilateral total hip arthroplasty based on physical exam and medical history including at least one of the following:
Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
Rheumatoid arthritis
High risk for dislocation
Undergoing revision hip arthroplasty
Correction of functional deformity
In need of treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
Patient is willing and able to complete scheduled follow-up evaluations as described in the protocol and Informed Consent
Patient, or the patient's legally authorized representative, has participated in the Informed Consent process and is willing and able to sign an IRB approved informed consent
Exclusion Criteria:
Patient is septic, has an active infection or has osteomyelitis at the affected joint
Patient has significant osteoporosis as defined by treating surgeon
Patient has metabolic disorder(s) which may impair bone formation
Patient has osteomalacia
Patient has distant foci of infections which may spread to the implant site
Patient has rapid joint destruction, marked bone loss or bone resorption on pre-operative radiographs
Patient underwent contralateral THA within 3 months of planned index procedure or has a contralateral THA planned within 3 months of the index procedure
Patient is undergoing simultaneous bilateral THA
Patient has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery.
In the opinion of the investigator, patient has any concomitant disease which is likely to jeopardize the functioning or success of the implant
Patient is known to be pregnant
The patient is in the vulnerable population group, such as
a prisoner
a known alcohol or drug abuser
mentally incompetent or unable to understand what participation in this study entails
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Darin A Fawley, MA
Phone
5743067230
Email
darin.fawley@zimmerbiomet.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Boylan, MBA
Phone
574-371-9784
Email
ryan.boylan@zimmerbiomet.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hillary Overholser
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
G7 Freedom Constrained Vivacit-E Liners
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