Overview

This trial is active, not recruiting.

Conditions noninflammatory degenerative joint disease, rheumatoid arthritis
Treatments metal on polyethylene articulation, ceramic on polyethylene articulation, ceramic on ceramic articulation
Phase phase 4
Sponsor Biomet, Inc.
Start date October 2013
End date April 2025
Trial size 315 participants
Trial identifier NCT02036931, ORTHO.CR.GH20.13

Summary

The primary purpose of this study is to evaluate the clinical and radiographic performance of the G7 Acetabular Cup System.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
G7 cup with Metal on Polyethylene articulation (MOP)
metal on polyethylene articulation MOP
G7 Acetabular Cup System with Metal head on Polyethylene liner articulation (MOP)
G7 cup with Ceramic on Polyethylene articulation (COP)
ceramic on polyethylene articulation COP
G7 Acetabular Cup System with Ceramic head on Polyethylene liner articulation (COP)
G7 cup with Ceramic on Ceramic articulation (COC)
ceramic on ceramic articulation COC
G7 Acetabular Cup System with Ceramic head on Ceramic linear articulation (COC) - Outside the United States ONLY

Primary Outcomes

Measure
Harris Hip Score
time frame: 2 Year

Secondary Outcomes

Measure
Oxford Hip Score
time frame: 1, 2, 5 Year post-operative
Radiographic Evaluation
time frame: 1, 2, and 5 Year post-operative
Survivorship
time frame: 7 and 10 Year post-operative
Adverse Events
time frame: 3-month, 1-year, 2 year, 5-year post-operative

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Description The primary purpose of this study is to evaluate the clinical and radiographic performance of the G7 Acetabular Cup System in both primary and revision procedures, report safety and survivorship, and document instrument ease of use.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Biomet, Inc..