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Prospective G7 Dual Mobility Total Hip PMCF

Sponsor
Zimmer Biomet (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03308929
Collaborator
(none)
250
Enrollment
6
Locations
144
Anticipated Duration (Months)
41.7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
250 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Multi-Center Clinical Evaluation Following Total Hip Arthroplasty With the G7 Dual Mobility System
Actual Study Start Date :
Feb 28, 2017
Anticipated Primary Completion Date :
Feb 28, 2024
Anticipated Study Completion Date :
Feb 28, 2029

Outcome Measures

Primary Outcome Measures

  1. Survivorship of the study device [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.

Secondary Outcome Measures

  1. Radiographic measurements of the implanted device [10 years]

    Standard AP radiographs of implanted hip will assess the positioning of the device as well as lucencies and other potential anomalies.

  2. Frequency and incidence of adverse events for all subjects with particular focus on those related or potentially related to the device [10 years]

    Assessed by tracking the type of adverse event, severity and relation of the event(s) to the study device

  3. Patient Physical Activity [10 years]

    UCLA activity score - patient self assessment

  4. Patient Quality of Life [10 years]

    EQ-3L-5D quality of life measure - patient self assessment

  5. Harris Hip Score [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
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
5 Tidewater Orthopaedics Hampton Virginia United States 23666
6 Ortho Virginia Richmond Virginia United States 23235

Sponsors and Collaborators

  • Zimmer Biomet

Investigators

  • Study Director: Kacy Arnold, MS, Zimmer Biomet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zimmer Biomet
ClinicalTrials.gov Identifier:
NCT03308929
Other Study ID Numbers:
  • H.CR.I.G.16.5
First Posted:
Oct 13, 2017
Last Update Posted:
Dec 16, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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

Study Results

No Results Posted as of Dec 16, 2021