A Multicentre Observational Study to Evaluate Clinical Outcomes of the G7 Acetabular System
- Conditions
- Hip ArthrosisHip Wear10005944
- Registration Number
- NL-OMON50332
- Lead Sponsor
- Biomet GSCC B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 21
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 should be in accordance with Contraindications for the G7
cup.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Harris Hip Score (HHS) at 2 year postoperative</p><br>
- Secondary Outcome Measures
Name Time Method <p>Oxford Hip Score at 1,2,5 year postop<br /><br>Radiographic Evaluation: radiographic outcome, stability, incidence of<br /><br>radiolucencies around the prosthesis and bone remodeling<br /><br>Adverse Events/Complications (including revisions/removals of the study hip).<br /><br>Survivorship</p><br>