Status:
ACTIVE_NOT_RECRUITING
Prospective G7 Dual Mobility Total Hip PMCF
Lead Sponsor:
Zimmer Biomet
Conditions:
Clinical Outcomes
Functional Outcomes
Eligibility:
All Genders
18-80 years
Brief 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-i...
Detailed Description
This multi-center prospective follow-up study will evaluate clinical outcomes, functional outcomes, radiological outcomes and further characterize the safety profile of the G7 Dual Mobility Hip Arthro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 28 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2029
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT03308929
Start Date
February 28 2017
End Date
February 28 2029
Last Update
June 15 2025
Active Locations (6)
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1
Jersey City Medical Center
Jersey City, New Jersey, United States, 07302
2
New Mexico Orthopaedics
Albuquerque, New Mexico, United States, 87106
3
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
4
Oregon Health and Science University
Portland, Oregon, United States, 97239