Status:
ACTIVE_NOT_RECRUITING
G7 Dual Mobility System Used in Total Hip Arthroplasty for the Treatment of Femoral Neck Fracture
Lead Sponsor:
Zimmer Biomet
Conditions:
Hip Fractures
Eligibility:
All Genders
55-80 years
Brief 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 include...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2028
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT04031209
Start Date
January 1 2020
End Date
March 1 2028
Last Update
December 18 2024
Active Locations (7)
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1
Seoul National University Hospital
Seoul, South Korea, 03080
2
Hanyang University Medical Center
Seoul, South Korea, 04763
3
Asan medical Centre
Seoul, South Korea, 05505
4
Seoul National University Bundang Hospital
Seoul, South Korea, 05505