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Completed

NCT Number: NCT02036931

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

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.

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Key information

Conditions

Noninflammatory Degenerative Joint Disease Arthritis Arthritis, Rheumatoid Autoimmune Diseases Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Necrosis Osteoarthritis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clermont-Ferrand Hospital, Clermont-Ferrand, France

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About this study

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 in both primary and revision procedures, report safety and survivorship, and document instrument ease of use.

Preoperative and intraoperative data have been collected retrospectively and follow ups have been collected prospectively.

Clinical outcomes included the Harris Hip Score, Oxford Hip Score, and Radiographic Evaluations collected at 3 month, 1, 2 and 5 year follow-up time points. For the 7 and 10 year follow-up intervals, survivorship and adverse events have been collected.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metal on Polyethylene articulation

Device

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

Other names: MOP

Ceramic on Polyethylene articulation

Device

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

Other names: COP

Ceramic on Ceramic articulation

Device

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

Other names: COC

Primary outcomes

  1. Harris Hip Score

    Time frame: Pre-operative,1, 2, and 5 years postoperatively

    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.

Secondary outcomes

  1. Oxford Hip Score

    Time frame: Pre-op, 1, 2, and 5 years postoperatively

    The Oxford Hip Score (OHS) is a patient-reported outcome measure that was developed to specifically assess the patient's perspective of outcome following THA. The OHS consists of twelve questions covering function and pain associated with the hip. To calculate the total score, each response is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as Excellent: > 41; Good: 34 - 41; Fair: 27 - 33; Poor: < 27.

  2. Survivorship

    Time frame: 7 and 10 Year post-operative

    Fraction of patients without a revision of any of the hip implant component, calculated with the Kaplan Meier (K-M) estimate.

  3. Survivorship

    Time frame: 10 Year post-operative

    Fraction of patients without a revision of any of the hip implant component, calculated with the Kaplan Meier (K-M) estimate.

  4. Radiographic Evaluation

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

    All radiographs have been reviewed by the investigators at each site in order to detect and report any abnormal and significant findings (including adverse events). The change from the angle of inclination between the different follow-ups is shown in the table.

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Important dates

Study start
2013
Primary completion
2024
Study completion
2025
First posted
Jan 15, 2014
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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