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

Retrospective and Prospective Multi-Center Outcomes Study of 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hip Fractures
• Intervention / Treatment: Device: G7 Acetabular System

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 275

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Centre
  • Seoul, Korea, Republic of, 04763
    • Hanyang University Medical Center
  • Seoul, Korea, Republic of, 06591
    • Seoul St. Mary'S Hospital
  • Seoul, Korea, Republic of, 130-872
    • KyungHee University Medical Center
  • Seoul, Korea, Republic of, 05505
    • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

The study population will consist of patients who required primary THA for treatment of femoral neck fracture and satisfy eligibility criteria outlined in this section. In order to avoid potential selection bias, each investigator will offer study participation to each consecutive eligible patient presenting as a candidate for primary THA using G7 Dual Mobility System.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
G7 G7 Acetabular System; All patients will receive G7 G7 Acetabular System	Device: G7 Acetabular System; All patients will receive G7 Acetabular System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant dislocation rate	Dislocation is defined as the complete loss of articulation contact between two artificial joint components.	One year post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain and Functional Performance by Oxford Hip Score	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.	Up to 5 years post-surgery
Implant survivorship by revision rates	Cumulative survival rates using a Kaplan-Meier analysis.	Up to 5 years post-surgery
Quality of life by EQ-5D-5L questionnaire	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'.	Up to 5 years post-surgery
Quality of life by JHEQ	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.	Up to 5 years post-surgery
Pain and Functional Performance by JOA Hip Score	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.	Up to 5 years post-surgery
Adverse events reported	Summary of adverse events by category, incidence and frequency	Up to 5 years post-surgery

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Principal Investigator: Kee-Hyung Rhyu, KyungHee University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: July 4, 2019
• First Submitted That Met QC Criteria: July 21, 2019
• First Posted (Actual): July 24, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Femoral Neck Fractures
• Other Study ID Numbers: CSA2019-02H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes