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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Rheumatoid Arthritis; Noninflammatory Degenerative Joint Disease
• Intervention / Treatment: Device: Metal on Polyethylene articulation; Drug: Ceramic on Polyethylene articulation; Device: Ceramic on Ceramic articulation

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 315

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • Clermont-Ferrand Hospital
• Germany
  • Würzburg, Germany
    • University of Würzburg, Orthopedic
• Ireland
  • Limerick, Ireland
    • Midwestern Regional Orthopaedic Hospital
• Netherlands
  • Delft, Netherlands
    • Reinier de Graaf Groep
• Spain
  • Ponferrada, Spain
    • Hospital El Bierzo
• United States
  • Arizona
    • Tucson, Arizona, United States, 85718
      • University Orthopedic Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Metal on Polyethylene articulation; G7 cup with Metal on Polyethylene articulation (MOP)	Device: Metal on Polyethylene articulation; G7 Acetabular Cup System with Metal head on Polyethylene liner articulation (MOP); Other Names: MOP
Ceramic on Polyethylene articulation; G7 cup with Ceramic on Polyethylene articulation (COP)	Drug: Ceramic on Polyethylene articulation; G7 Acetabular Cup System with Ceramic head on Polyethylene liner articulation (COP); Other Names: COP
Ceramic on Ceramic articulation; G7 cup with Ceramic on Ceramic articulation (COC)	Device: Ceramic on Ceramic articulation; G7 Acetabular Cup System with Ceramic head on Ceramic linear articulation (COC) - Outside the United States ONLY; Other Names: COC

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Hassan Achakri, PhD, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: January 14, 2014
• First Submitted That Met QC Criteria: January 14, 2014
• First Posted (Estimated): January 15, 2014

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Osteoarthritis; Avascular Necrosis; Joint
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Joint Diseases
• Other Study ID Numbers: ORTHO.CR.GH20.13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No