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A Multicentre Observational Study to Evaluate Clinical Outcomes of the G7 Acetabular System

NCT02036931

CompletedN/A

Sponsor: Zimmer Biomet

Conditions: Noninflammatory Degenerative Joint Disease, Rheumatoid Arthritis

Interventions: Metal on Polyethylene articulation, Ceramic on Polyethylene articulation, Ceramic on Ceramic articulation

Countries: United States, France, Germany, Ireland, Netherlands, Spain

This is a prospective observational multi-center non-controlled study. The primary purpose of this study is to evaluate the clinical and radiographic performance of the G7 Acetabular Cup System.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* 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
* 18 years of age or older
* Subjects willing to return for follow-up evaluations

Exclusion Criteria:

* Infection, sepsis and osteomyelitis
* Subjects unable to cooperate with and complete the study
* Neurological conditions affecting movement
* Pregnancy

Locations (6)

Tucson, Arizona, United States
Clermont-Ferrand, France
Würzburg, Germany
Limerick, Ireland
Delft, Netherlands
Ponferrada, Spain