Prospective G7 Dual Mobility Total Hip PMCF

Prospective Multi-Center Clinical Evaluation Following Total Hip Arthroplasty With the G7 Dual Mobility System

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Clinical Outcomes; Survivorship; Safety; Functional Outcomes; Radiological Outcomes
• Intervention / Treatment: Device: G7 Dual Mobility hip

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 Arthroplasty System. This will be accomplished by assessing these domains using the Harris Hip Score, UCLA Activity Score, and EQ-5D-3L, obtaining and assessing radiographs and the tracking of device or procedure related adverse events. Subjects will undergo unilateral primary or revision total hip arthroplasty and will then be followed for 10 years with intervals at 6 weeks, 1-, 2-, 3- 5- and 10 years. For the 10 year visit, subjects will not be required to present in their doctor's office, but will fill out a survey. Subsequent to 10 year data collection, the subject's participation in the study will be compete.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Jersey City, New Jersey, United States, 07302
      • Jersey City Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • New Mexico Orthopaedics
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Virginia
    • Hampton, Virginia, United States, 23666
      • Tidewater Orthopaedics
    • Richmond, Virginia, United States, 23235
      • Ortho Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic measurements of the implanted device	Standard AP radiographs of implanted hip will assess the positioning of the device as well as lucencies and other potential anomalies.	10 years
Frequency and incidence of adverse events for all subjects with particular focus on those related or potentially related to the device	Assessed by tracking the type of adverse event, severity and relation of the event(s) to the study device	10 years
Patient Physical Activity	UCLA activity score - patient self assessment	10 years
Patient Quality of Life	EQ-3L-5D quality of life measure - patient self assessment	10 years
Harris Hip Score	Harris Hip score measures pain, function, absence of deformity, and range of motion. Scores range from 0-100 with higher scores representing less dysfunction and better outcomes	10 years

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Hillary Overholser, MS, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2017
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): February 28, 2029

Study Registration Dates

• First Submitted: April 24, 2017
• First Submitted That Met QC Criteria: October 6, 2017
• First Posted (Actual): October 13, 2017

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: H.CR.I.G.16.5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes