Prospective G7 Dual Mobility Total Hip PMCF

Running, not enrolling

Conditions studied: Clinical Outcomes, Functional Outcomes, Radiological Outcomes, Survivorship, Safety

In brief

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.

Key facts

Study ID

NCT03308929

Run by

Zimmer Biomet

People needed

250

Starts

2017-02-28

Expected to finish

2029-02-28

Last updated by the study team

2025-06-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Jersey City Medical Center — Jersey City, New Jersey, United States
• New Mexico Orthopaedics — Albuquerque, New Mexico, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Tidewater Orthopaedics — Hampton, Virginia, United States
• Ortho Virginia — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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