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

  • STATUS
    Recruiting
  • End date
    Mar 23, 2028
  • participants needed
    300
  • sponsor
    Zimmer Biomet
Updated on 23 July 2021
hip arthroplasty
femoral neck fracture

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

Details
Condition HIP FRACTURE, hip fractures, broken hip
Treatment G7 Acetabular System
Clinical Study IdentifierNCT04031209
SponsorZimmer Biomet
Last Modified on23 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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