Active, not recruiting
Observational
Prospective G7 Dual Mobility Total Hip PMCF
Condition(s) studied
Clinical OutcomesFunctional OutcomesRadiological OutcomesSurvivorshipSafety
Investigational drug(s) / intervention(s)
G7 Dual Mobility hip
G7 Dual Mobility hip: Total hip arthroplasty and implantation of the G7 device
Study summary
This is a prospective multi-center clinical evaluation following recipients of the G7 Dual Mobility hip device. The primary objective is to characterize survivorship of the G7 hip at five years post-index procedure. Secondary objectives include documentation of clinical outcomes, safety and radiographic data.
Eligibility
Inclusion Criteria:
* Patients who are undergoing revision hip arthroplasty
-OR
* Patients who are undergoing total hip arthroplasty (THA) for the correction of a functional deformity
\- OR
* Patients in need of treatment of femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
\- OR
* Patients suffer from substantial pain and/or limited function, are appropriate for a primary total hip arthroplasty, considered at high risk for dislocation and have one of the following:
* Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
* Rheumatoid arthritis
* Decision to have a G7 Dual Mobility system implanted was made independently and prior to recruitment into study
* From 18 to 80 years of age (inclusive) at time of procedure
* BMI equal to or less than 35
* Unilateral total hip replacement
* Willing and able to comply with the study procedures
Exclusion Criteria:
* Patients undergoing total hip arthroplasty following non-union of previous surgically treated fracture.
* Infection, sepsis or osteomyelitis at the affected joint
* Significant osteoporosis as defined by treating surgeon
* Metabolic disorders which may impair bone formation
* Osteomalacia
* Distant foci of infections which may spread to the implant site
* Rapid joint destruction, marked bone loss or bone resorption on preoperative radiographs
* Underwent contralateral THA within 12 months of planned index procedure
* Contralateral THA planned within 12 months of index procedure
* Vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease
* The patient is
* A prisoner
* A known alcohol or drug abuser
* The patient has any concomitant disease which is likely to jeopardize the functioning or success of the implant
* The patient is known to be pregnant
* The patient has a known sensitivity or allergy to one or more of the implanted materials, inducing but not limited to chromium, cobalt, and ceramic
Primary outcome measure(s)
- Survivorship of the study device — 5 years
This is assessed by removal of the study device from the patient for any reason, including failure of the device, infection, or traumatic injury.
Trial sites (6)
| Facility | City | Region | Status |
| Jersey City Medical Center |
Jersey City |
New Jersey |
|
| New Mexico Orthopaedics |
Albuquerque |
New Mexico |
|
| University of North Carolina |
Chapel Hill |
North Carolina |
|
| Oregon Health and Science University |
Portland |
Oregon |
|
| Tidewater Orthopaedics |
Hampton |
Virginia |
|
| Ortho Virginia |
Richmond |
Virginia |
|
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