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

Hip Fractures Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04031209
• Other study ID #: CSA2019-02H
• Status: Active, not recruiting
• Start date: January 1, 2020
• Est. completion date: March 2028

Study information

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

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 275
• Est. completion date: March 2028
• Est. primary completion date: December 2027
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fractures, Bone
• Hip Fractures

Intervention

Device:
• G7 Acetabular System
All patients will receive G7 Acetabular System

Locations

Country	Name	City	State
Korea, Republic of	Asan medical Centre	Seoul
Korea, Republic of	Hanyang University Medical Center	Seoul
Korea, Republic of	KyungHee University Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Bundang Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant dislocation rate	Dislocation is defined as the complete loss of articulation contact between two artificial joint components.	One year post-surgery
Secondary	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
Secondary	Implant survivorship by revision rates	Cumulative survival rates using a Kaplan-Meier analysis.	Up to 5 years post-surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse events reported	Summary of adverse events by category, incidence and frequency	Up to 5 years post-surgery