Status:
WITHDRAWN
MDR - G7 Neutral and G7 Freedom Constrained Neutral Acetabular Liners
Lead Sponsor:
Zimmer Biomet
Conditions:
Hip Osteoarthritis
Hip Disease
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the G7 Freedom Constrained Liners when used for primary and revision tota...
Detailed Description
The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the G7 Freedom Constrained Liners when used for primary and revision tota...
Eligibility Criteria
Inclusion
- Patient must be 18 years of age or older and skeletally mature
- Patient must be willing and able to sign Institution Review Board (IRB) approved informed consent
- Noninflammatory degenerative joint disease including:
- Osteoarthritis
- 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
- High risk of dislocation due to:
- History of prior dislocation
- Bone loss
- Joint or soft tissue laxity
- Neuromuscular disease
- Intraoperative instability
- Revision procedures where other treatment or devices have failed
Exclusion
- Off-label use
- Infection and/or distant foci of infections which may spread to the implant site
- Sepsis
- Osteomyelitis
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions
- Osteoporosis
- Metabolic disorders which may impair bone formation
- Osteomalacia
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- Vascular insufficiency, muscular atrophy or neuromuscular disease
- Patient is known to be pregnant or nursing
- Patient is a prisoner
- Patient is a known alcohol or drug abuser
- Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
- Patient is unwilling to sign an informed consent
Key Trial Info
Start Date :
April 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2029
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04093739
Start Date
April 1 2022
End Date
December 31 2029
Last Update
December 13 2023
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.