A Multicentre Observational Study to Evaluate Clinical Outcomes of the G7 Acetabular System
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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 in both primary and revision procedures, report safety and survivorship, and document instrument ease of use.
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
162 participants in 3 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal