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

NCT02036931 | Completed Results

• 1 other identifier: ORTHO.CR.GH20
• Study Type: observational
• Target: 162
• Locations: 6 countries
• Sites: 6

Brief Summary

This is a prospective observational multi-center non-controlled study. The primary purpose of this study is to evaluate the clinical and radiographic performance of the G7 Acetabular Cup System.

Conditions

Noninflammatory Degenerative Joint Disease; Rheumatoid Arthritis

Keywords

Joint; Osteoarthritis; Avascular Necrosis

Outcome Measures

Primary Outcomes (1)

• Harris Hip Score

  The Harris Hip Scale (HHS) is an outcome measure that includes a series of questions answered by the patient and physical examinations recorded by a qualified health care professional. The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, o-5 points). To obtain a final score, the points are summed. The outcome score can be categorized as Excellent:90 - 100; Good: 80 - 90; Fair: 70 - 80; Poor: \< 70.

  Pre-operative,1, 2, and 5 years postoperatively

Secondary Outcomes (4)

• Oxford Hip Score

  Pre-op, 1, 2, and 5 years postoperatively

• Survivorship

  7 and 10 Year post-operative

• Survivorship

  10 Year post-operative

• Radiographic Evaluation

  Immediate post-op, 3 months, 1, 2, and 5 years

Study Arms (3)

Metal on Polyethylene articulation

G7 cup with Metal on Polyethylene articulation (MOP)

Device: Metal on Polyethylene articulation

Ceramic on Polyethylene articulation

G7 cup with Ceramic on Polyethylene articulation (COP)

Device: Ceramic on Polyethylene articulation

Ceramic on Ceramic articulation

G7 cup with Ceramic on Ceramic articulation (COC)

Device: Ceramic on Ceramic articulation

Interventions

Metal on Polyethylene articulation DEVICE

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

Also known as: MOP

Metal on Polyethylene articulation

Ceramic on Polyethylene articulation DEVICE

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

Also known as: COP

Ceramic on Polyethylene articulation

Ceramic on Ceramic articulation DEVICE

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

Also known as: COC

Ceramic on Ceramic articulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• 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
• years of age or older
• Subjects willing to return for follow-up evaluations

You may not qualify if:

• Infection, sepsis and osteomyelitis
• Subjects unable to cooperate with and complete the study
• Neurological conditions affecting movement
• Pregnancy

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (6)

University Orthopedic Specialists

Tucson, Arizona, 85718, United States

Location

Clermont-Ferrand Hospital

Clermont-Ferrand, France

Location

University of Würzburg, Orthopedic

Würzburg, Germany

Location

Midwestern Regional Orthopaedic Hospital

Limerick, Ireland

Location

Reinier de Graaf Groep

Delft, Netherlands

Location

Hospital El Bierzo

Ponferrada, Spain

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Osteoarthritis; Osteonecrosis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Oliver Marti
• Organization: Zimmer Biomet

oliver.marti1@zimmerbiomet.com

+41 79 576 31 98

Study Officials

• Emilie Rohmer

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 15, 2014
• Study Start: March 1, 2013
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: December 19, 2025
• Results First Posted: December 19, 2025

Record last verified: 2025-12

Locations

IE (1); US (1); FR (1); DE (1); ES (1); NL (1)