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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02036931
• Other study ID #: ORTHO.CR.GH20.13
• Status: Active, not recruiting
• Start date: March 2013
• Est. completion date: April 2025

Study information

• Verified date: October 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 315
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Joint Diseases
• Noninflammatory Degenerative Joint Disease
• Osteoarthritis
• Rheumatoid Arthritis

Intervention

Device:
• Metal on Polyethylene articulation
G7 Acetabular Cup System with Metal head on Polyethylene liner articulation (MOP)

Drug:
• Ceramic on Polyethylene articulation
G7 Acetabular Cup System with Ceramic head on Polyethylene liner articulation (COP)

Device:
• Ceramic on Ceramic articulation
G7 Acetabular Cup System with Ceramic head on Ceramic linear articulation (COC) - Outside the United States ONLY

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

United States,  France,  Germany,  Ireland,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Survivorship	Questionnaire	7 Year post-operative
Secondary	Survivorship	Questionnaire	10 Year post-operative
Secondary	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