NL-OMON50332RecruitingNot Applicable
A Multicentre Observational Study to Evaluate Clinical Outcomes of the G7 Acetabular System - G7 Early evaluators
Biomet GSCC B.V.0 sites21 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 21
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Selection of subjects for this evaluation should be in accordance with the
- •indications of the G7 cup specifically:
- •Subjects with one of the following indication:
- •- Noninflammatory degenerative joint disease including osteoarthritis and
- •avascular necrosis.
- •- Rheumatoid arthritis.
- •- Correction of functional deformity.
- •- Treatment of non-union, femoral neck fracture, and trochanteric fractures of
- •the proximal femur with head involvement, unmanageable by other techniques.
- •- Revision procedures where other treatment or devices have failed.
- •Additional inclusion criteria include:
- •- Male or female.
- •- 18 years of age or older
- •- Subjects willing to return for follow-up evaluations.
Exclusion Criteria
- •Exclusion criteria should be in accordance with Contraindications for the G7
- •Absolute contraindications include: infection, sepsis and osteomyelitis,
- •Additional contraindications include:
- •- Subjects unable to cooperate with and complete the study
- •- Dementia and inability to understand and follow instructions
- •- Neurological conditions affecting movement
- •- Pregnancy
Investigators
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