Prospective G7 Dual Mobility Total Hip PMCF

NCT03308929 | Active Not Recruiting FDA Device

• 1 other identifier: H.CR.I.G.16.5
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 6

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-index procedure. Secondary objectives include documentation of clinical outcomes, safety and radiographic data.

Conditions

Clinical Outcomes; Functional Outcomes; Radiological Outcomes; Survivorship; Safety

Outcome Measures

Primary Outcomes (1)

• Survivorship of the study device

  This is assessed by removal of the study device from the patient for any reason, including failure of the device, infection, or traumatic injury.

  5 years

Secondary Outcomes (5)

• Radiographic measurements of the implanted device

  10 years

• Frequency and incidence of adverse events for all subjects with particular focus on those related or potentially related to the device

  10 years

• Patient Physical Activity

  10 years

• Patient Quality of Life

  10 years

• Harris Hip Score

  10 years

Interventions

G7 Dual Mobility hip DEVICE

Total hip arthroplasty and implantation of the G7 device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing revision hip arthroplasty, undergoing a hip arthroplasty to correct a functional deformity, patients seeking treatment for femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques, and patients with significant hip pain or functional limitations and who are at a high dislocation risk will be considered for the study. Patients may have avascular necrosis, osteo- or rheumatoid arthritis.

You may qualify if:

• Patients who are undergoing revision hip arthroplasty
• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (6)

Jersey City Medical Center

Jersey City, New Jersey, 07302, United States

Location

New Mexico Orthopaedics

Albuquerque, New Mexico, 87106, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Tidewater Orthopaedics

Hampton, Virginia, 23666, United States

Location

Ortho Virginia

Richmond, Virginia, 23235, United States

Location

Study Officials

• Hillary Overholser, MS

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: October 13, 2017
• Study Start: February 28, 2017
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): February 28, 2029
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

US (6)