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

Active, not recruiting

• Conditions: Rheumatoid Arthritis; Noninflammatory Degenerative Joint Disease
• Interventions: Device: Metal on Polyethylene articulation; Device: Ceramic on Ceramic articulation; Drug: Ceramic on Polyethylene articulation

• Registration Number: NCT02036931
• Lead Sponsor: Zimmer Biomet

Brief Summary

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

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 Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-14
• Study First Posted: 2014-01-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-28
• Last Update Posted: 2024-12-02
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 315

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Metal on Polyethylene articulation	Metal on Polyethylene articulation	G7 cup with Metal on Polyethylene articulation (MOP)
Ceramic on Ceramic articulation	Ceramic on Ceramic articulation	G7 cup with Ceramic on Ceramic articulation (COC)
Ceramic on Polyethylene articulation	Ceramic on Polyethylene articulation	G7 cup with Ceramic on Polyethylene articulation (COP)

Primary Outcome Measures

Name	Time	Method
Harris Hip Score	2 Year post-operative	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.

Secondary Outcome Measures

Name	Time	Method
Radiographic Evaluation	5 Year post-operative	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.
Survivorship	10 Year post-operative	Questionnaire
Oxford Hip Score	5 Year post-operative	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.
Adverse Events	Up to 10 years postoperatively	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.

Trial Locations

Locations (6)

Midwestern Regional Orthopaedic Hospital; 🇮🇪 Limerick, Ireland

Reinier de Graaf Groep; 🇳🇱 Delft, Netherlands

University Orthopedic Specialists; 🇺🇸 Tucson, Arizona, United States

University of Würzburg, Orthopedic; 🇩🇪 Würzburg, Germany

Clermont-Ferrand Hospital; 🇫🇷 Clermont-Ferrand, France

Hospital El Bierzo; 🇪🇸 Ponferrada, Spain