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

N/AActive Not RecruitingNCT04031209

Zimmer Biomet275 enrolled

Overview

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.

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

275

Conditions

Hip Fractures

Interventions

G7 Acetabular SystemDEVICE

All patients will receive G7 Acetabular System

Eligibility

Sex: ALLMin age: 55 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (7)

Seoul National University Hospital

Seoul, South Korea

Hanyang University Medical Center

Seoul, South Korea

Asan medical Centre

Seoul, South Korea

Seoul National University Bundang Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Implant dislocation rate

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

Time frame: One year post-surgery

Secondary Outcomes

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.

Time frame: Up to 5 years post-surgery

Implant survivorship by revision rates

Cumulative survival rates using a Kaplan-Meier analysis.

Time frame: 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'.

Time frame: 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.

Data from ClinicalTrials.gov

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