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Prospective G7 Dual Mobility Total Hip PMCF

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ClinicalTrials.gov Identifier: NCT03308929
Recruitment Status : Enrolling by invitation
First Posted : October 13, 2017
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Tracking Information
First Submitted Date April 24, 2017
First Posted Date October 13, 2017
Last Update Posted Date March 27, 2020
Actual Study Start Date February 28, 2017
Estimated Primary Completion Date February 28, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 6, 2017)
Survivorship of the study device [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 9, 2019)
  • Radiographic measurements of the implanted device [ Time Frame: 10 years ]
    Standard AP radiographs of implanted hip will assess the positioning of the device as well as lucencies and other potential anomalies.
  • Frequency and incidence of adverse events for all subjects with particular focus on those related or potentially related to the device [ Time Frame: 10 years ]
    Assessed by tracking the type of adverse event, severity and relation of the event(s) to the study device
  • Patient Physical Activity [ Time Frame: 10 years ]
    UCLA activity score - patient self assessment
  • Patient Quality of Life [ Time Frame: 10 years ]
    EQ-3L-5D quality of life measure - patient self assessment
  • Harris Hip Score [ Time Frame: 10 years ]
    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
Original Secondary Outcome Measures
 (submitted: October 6, 2017)
  • Radiographic measurements of the implanted device [ Time Frame: 10 years ]
    Standard AP radiographs of implanted hip will assess the positioning of the device as well as lucencies and other potential anomalies.
  • Safety profile of the G7 Dual Mobility device [ Time Frame: 10 years ]
    assessed by tracking all adverse events for all subjects with particular focus on those related or potentially related to the device
  • Patient Physical Activity [ Time Frame: 10 years ]
    UCLA activity score - patient self assessment
  • Patient Quality of Life [ Time Frame: 10 years ]
    EQ-3L-5D quality of life measure - patient self assessment
  • Harris Hip Score [ Time Frame: 10 years ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective G7 Dual Mobility Total Hip PMCF
Official Title Prospective Multi-Center Clinical Evaluation Following Total Hip Arthroplasty With the G7 Dual Mobility System
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Clinical Outcomes
  • Functional Outcomes
  • Radiological Outcomes
  • Survivorship
  • Safety
Intervention Device: G7 Dual Mobility hip
Total hip arthroplasty and implantation of the G7 device
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: October 6, 2017)
250
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 28, 2029
Estimated Primary Completion Date February 28, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03308929
Other Study ID Numbers H.CR.I.G.16.5
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Zimmer Biomet
Study Sponsor Zimmer Biomet
Collaborators Not Provided
Investigators
Study Director: Kacy Arnold, MS Zimmer Biomet
PRS Account Zimmer Biomet
Verification Date March 2020