Ireland
--:--IST
Active, not recruiting Observational

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

NCT04031209 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2020-01-01
Last updated
2024-12-18

Condition(s) studied

Hip Fractures

Investigational drug(s) / intervention(s)

G7 Acetabular System

G7 Acetabular System: All patients will receive G7 Acetabular System

Study 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.

Eligibility

Sex
ALL
Min age
55 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Implant dislocation rate — One year post-surgery
    Dislocation is defined as the complete loss of articulation contact between two artificial joint components.

Trial sites (7)

FacilityCityRegionStatus
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
Samsung Medical Center Seoul South Korea
Seoul St. Mary's Hospital Seoul South Korea
KyungHee University Medical Center Seoul South Korea

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04031209 on ClinicalTrials.gov ↗ ← All trials in South Korea