Hip Arthrosis Hip Wear
Conditions
Interventions
The use of a G7 cup in total hip replacement.
Sponsors
Biomet GSCC B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Harris Hip Score (HHS) at 2 year postoperative | — |
Secondary
| Measure | Time frame |
|---|---|
| Oxford Hip Score at 1,2,5 year postop Radiographic Evaluation: radiographic outcome, stability, incidence of radiolucencies around the prosthesis and bone remodeling Adverse Events/Complications (including revisions/removals of the study hip). Survivorship | — |
Countries
Netherlands
Outcome results
None listed