A Multicentre Observational Study to Evaluate Clinical Outcomes of the G7 Acetabular System
NCT ID: NCT02036931
Last Updated: 2025-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
162 participants
OBSERVATIONAL
2013-03-31
2025-05-31
Brief Summary
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Detailed Description
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Preoperative and intraoperative data have been collected retrospectively and follow ups have been collected prospectively.
Clinical outcomes included the Harris Hip Score, Oxford Hip Score, and Radiographic Evaluations collected at 3 month, 1, 2 and 5 year follow-up time points. For the 7 and 10 year follow-up intervals, survivorship and adverse events have been collected.
Conditions
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Keywords
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Study Design
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COHORT
OTHER
Study Groups
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Metal on Polyethylene articulation
G7 cup with Metal on Polyethylene articulation (MOP)
Metal on Polyethylene articulation
G7 Acetabular Cup System with Metal head on Polyethylene liner articulation (MOP)
Ceramic on Polyethylene articulation
G7 cup with Ceramic on Polyethylene articulation (COP)
Ceramic on Polyethylene articulation
G7 Acetabular Cup System with Ceramic head on Polyethylene liner articulation (COP)
Ceramic on Ceramic articulation
G7 cup with Ceramic on Ceramic articulation (COC)
Ceramic on Ceramic articulation
G7 Acetabular Cup System with Ceramic head on Ceramic linear articulation (COC) - Outside the United States ONLY
Interventions
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Metal on Polyethylene articulation
G7 Acetabular Cup System with Metal head on Polyethylene liner articulation (MOP)
Ceramic on Polyethylene articulation
G7 Acetabular Cup System with Ceramic head on Polyethylene liner articulation (COP)
Ceramic on Ceramic articulation
G7 Acetabular Cup System with Ceramic head on Ceramic linear articulation (COC) - Outside the United States ONLY
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Subjects unable to cooperate with and complete the study
* Neurological conditions affecting movement
* Pregnancy
18 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Principal Investigators
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Emilie Rohmer
Role: STUDY_DIRECTOR
Zimmer Biomet
Locations
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University Orthopedic Specialists
Tucson, Arizona, United States
Clermont-Ferrand Hospital
Clermont-Ferrand, , France
University of Würzburg, Orthopedic
Würzburg, , Germany
Midwestern Regional Orthopaedic Hospital
Limerick, , Ireland
Reinier de Graaf Groep
Delft, , Netherlands
Hospital El Bierzo
Ponferrada, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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ORTHO.CR.GH20
Identifier Type: -
Identifier Source: org_study_id