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NCT Number: NCT04031209

G7 Dual Mobility System Used in Total Hip Arthroplasty for the Treatment of Femoral Neck Fracture

This is a retrospective and prospective, multi-center, non-comparative, post market clinical follow-up study involving orthopedic surgeons skilled in THA and experienced implanting the devices included in this study.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hip Fractures Femoral Fractures Fractures, Bone Hip Injuries Leg Injuries Wounds and Injuries

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan medical Centre, Seoul, South Korea

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About this study

The objectives of the study are to document the performance and safety of the G7 Dual Mobility System when used in primary total hip arthroplasty for the treatment of femoral neck fracture by analysis of standard scoring systems, radiographs, revision and adverse event records.The study will include a maximum of 15 centers and up to 300 implanted hips. Each center may enroll up to a maximum of 40 hips to permit the consistency of outcomes across a variety of investigators and clinical setting

Who can participate

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

Inclusion criteria

  • 55 to 80 years of age, inclusive
  • Skeletally mature
  • Have undergo treatment or in need of primary THA treatment of non-union, femoral neck fracture, unmanageable by other techniques
  • Have G7 Dual Mobility system implanted or decision to have a G7 Dual Mobility system implanted was made independently and prior to recruitment into study
  • Willing and able to complete scheduled follow-up evaluations as described in the study protocol
  • Has participated in the Informed Consent process and is willing and able to sign an IRB/EC approved informed consent

Exclusion criteria

  • Is septic, has an active infection or has osteomyelitis at the affected joint
  • Has significant osteoporosis as defined by treating surgeon
  • Has metabolic disorder(s) which may impair bone formation
  • Has osteomalacia
  • Has distant foci of infections which may spread to the implant site
  • Has rapid joint destruction, marked bone loss or bone resorption on pre-operative radiographs
  • Has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery
  • Has any concomitant disease which is likely to jeopardize the functioning or success of the implant
  • Is known to be pregnant
  • Is a prisoner, known alcohol or drug abuser or mentally incompetent or unable to understand what participation in this study entails
  • Has a known sensitively or allergy to one or more of

Treatment and study plan

G7 Acetabular System

Device

All patients will receive G7 Acetabular System

Primary outcomes

  1. Implant dislocation rate

    Time frame: One year post-surgery

    Dislocation is defined as the complete loss of articulation contact between two artificial joint components.

Secondary outcomes

  1. Pain and Functional Performance by Oxford Hip Score

    Time frame: Up to 5 years post-surgery

    The Oxford Hip score consist of 12 disease-specific questions measuring patient-reported pain and function of the hip joint. Responses to each question are formatted as a 5-point Likert scale, scored from 0 (the worst outcome/most symptoms) to 4 (the best outcome / least symptoms). The scores for each question are added together for a final result between 0 and 48.

  2. Implant survivorship by revision rates

    Time frame: Up to 5 years post-surgery

    Cumulative survival rates using a Kaplan-Meier analysis.

  3. Quality of life by EQ-5D-5L questionnaire

    Time frame: Up to 5 years post-surgery

    This 5-level EQ-5D version (EQ-5D-5L) consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. A 1-digit number expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The health states may be converted into a single index value where 1 represents full health and 0 represents death. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.

  4. Quality of life by JHEQ

    Time frame: Up to 5 years post-surgery

    The Japanese Orthopaedic Association hip disease evaluation questionnaire (JHEQ) is a self-administered questionnaire that evaluates the quality of life in patients with hip disease. The questionnaire consists of three subscales: pain (28 points), movement (28 points), and mental (28 points), with higher scores indicating a better outcome. This measurement is applicable to Japanese population only.

  5. Pain and Functional Performance by JOA Hip Score

    Time frame: Up to 5 years post-surgery

    The Japanese Orthopaedic Association (JOA) hip score consists of four subcategories: pain (Pain, 40 points), range of motion (ROM, 20 points), ability to walk (Gait, 20 points), and activities of daily life (ADL, 20 points), with higher scores indicating a better outcome. This measurement is applicable to Japanese population only.

  6. Adverse events reported

    Time frame: Up to 5 years post-surgery

    Summary of adverse events by category, incidence and frequency

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

Retrospective and Prospective Multi-Center Outcomes Study of G7 Dual Mobility System Used in Total Hip Arthroplasty for the Treatment of Femoral Neck Fracture

Important dates

Study start
2020
Primary completion
2027
Study completion
2028
First posted
Jul 24, 2019
Registry last updated
Dec 18, 2024

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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