A Multicentre Observational Study to Evaluate Clinical Outcomes of the G7 Acetabular System

Study Overview
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Brief Summary
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The primary purpose of this study is to evaluate the clinical and radiographic performance of the G7 Acetabular Cup System.

Detailed Description
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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.

Official Title
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A Multicentre Observational Study to Evaluate Clinical Outcomes of the G7 Acetabular System

Conditions
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Noninflammatory Degenerative Joint Disease, Rheumatoid Arthritis

Intervention / Treatment
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* Device: Metal on Polyethylene articulation
* Drug: Ceramic on Polyethylene articulation
* Device: Ceramic on Ceramic articulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis Rheumatoid arthritis Correction of functional deformity Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques Revision procedures where other treatment or devices have failed 18 years of age or older Subjects willing to return for follow-up evaluations Exclusion Criteria: Infection, sepsis and osteomyelitis Subjects unable to cooperate with and complete the study Neurological conditions affecting movement Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Metal on Polyethylene articulation<br>G7 cup with Metal on Polyethylene articulation (MOP) | Device: Metal on Polyethylene articulation<br>* G7 Acetabular Cup System with Metal head on Polyethylene liner articulation (MOP)<br>* Other names: MOP;|
| Ceramic on Polyethylene articulation<br>G7 cup with Ceramic on Polyethylene articulation (COP) | Drug: Ceramic on Polyethylene articulation<br>* G7 Acetabular Cup System with Ceramic head on Polyethylene liner articulation (COP)<br>* Other names: COP;|
| Ceramic on Ceramic articulation<br>G7 cup with Ceramic on Ceramic articulation (COC) | Device: Ceramic on Ceramic articulation<br>* G7 Acetabular Cup System with Ceramic head on Ceramic linear articulation (COC) - Outside the United States ONLY<br>* Other names: COC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score | The Harris Hip Scale (HHS) was developed to assess the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in adults. The original version was published 1969. The HHS is an outcome measure administered by a qualified health care professional, such as a physician or a physical therapist. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent. | 2 Year post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Hip Score | The Oxford Hip Score (OHS) is a standard patient-reported outcome measure tool designed to assess function and pain in patients undergoing total hip replacement (THR). Each item has five possible responses. Responses go from 1 = least difficult to 5= most difficult. Item scores are summed to give a total score from anywhere between 12 and 60. The lower the score, the better the outcome. | 1 Year post-operative | 
| Oxford Hip Score | The Oxford Hip Score (OHS) is a standard patient-reported outcome measure tool designed to assess function and pain in patients undergoing total hip replacement (THR). Each item has five possible responses. Responses go from 1 = least difficult to 5= most difficult. Item scores are summed to give a total score from anywhere between 12 and 60. The lower the score, the better the outcome. | 2 Year post-operative | 
| Oxford Hip Score | The Oxford Hip Score (OHS) is a standard patient-reported outcome measure tool designed to assess function and pain in patients undergoing total hip replacement (THR). Each item has five possible responses. Responses go from 1 = least difficult to 5= most difficult. Item scores are summed to give a total score from anywhere between 12 and 60. The lower the score, the better the outcome. | 5 Year post-operative | 
| Radiographic Evaluation | Radiolucencies (mm), Stability, Angle of Inclination (degree). The degree of osseous-fixation will be graded using the following system; 0-1mm radiolucencies will be classed as fixated; >1-2mm radiolucencies will be classed as not fixated; >2mm radiolucencies will be classed as unstable. If more than 50% of the 3 zones have radiolucencies of greater than 1mm, then the implant is considered not to be well fixed. The angle of Inclination is the angle between the plane of the acetabular cup and the transichial line. | 1 Year post-operative | 
| Radiographic Evaluation | Radiolucencies (mm), Stability, Angle of Inclination (degree). The degree of osseous-fixation will be graded using the following system; 0-1mm radiolucencies will be classed as fixated; >1-2mm radiolucencies will be classed as not fixated; >2mm radiolucencies will be classed as unstable. If more than 50% of the 3 zones have radiolucencies of greater than 1mm, then the implant is considered not to be well fixed. The angle of Inclination is the angle between the plane of the acetabular cup and the transichial line. | 2 Year post-operative | 
| Radiographic Evaluation | Radiolucencies (mm), Stability, Angle of Inclination (degree). The degree of osseous-fixation will be graded using the following system; 0-1mm radiolucencies will be classed as fixated; >1-2mm radiolucencies will be classed as not fixated; >2mm radiolucencies will be classed as unstable. If more than 50% of the 3 zones have radiolucencies of greater than 1mm, then the implant is considered not to be well fixed. The angle of Inclination is the angle between the plane of the acetabular cup and the transichial line. | 5 Year post-operative | 
| Survivorship | Questionnaire | 7 Year post-operative | 
| Survivorship | Questionnaire | 10 Year post-operative | 
| Adverse Events | Adverse events will be documented according to ISO 14155:2011 definitions previously described. For the purposes of this study, only adverse events meeting SAE, ADE, SADE, and USADE criteria will be included, unless otherwise reported at the discretion of the investigator. | Up to 10 years postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Joint, Osteoarthritis, Avascular Necrosis