Clinical trial NCT03308929: Prospective G7 Dual Mobility Total Hip PMCF
Official title: Prospective Multi-Center Clinical Evaluation Following Total Hip Arthroplasty With the G7 Dual Mobility System
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Clinical Outcomes
Functional Outcomes
Radiological Outcomes
Survivorship
Safety
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2017-10-13
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Survivorship of the study device
timeFrame: 5 years
Secondary outcomes:
measure: Radiographic measurements of the implanted device
timeFrame: 10 years
measure: Frequency and incidence of adverse events for all subjects with particular focus on those related or potentially related to the device
timeFrame: 10 years
measure: Patient Physical Activity
timeFrame: 10 years
measure: Patient Quality of Life
timeFrame: 10 years
measure: Harris Hip Score
timeFrame: 10 years
Other outcomes:
Locations:
city: Jersey City
country: United States
facility: Jersey City Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Orthopaedics
state: New Mexico
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Hampton
country: United States
facility: Tidewater Orthopaedics
state: Virginia
city: Richmond
country: United States
facility: Ortho Virginia
state: Virginia
Study officials:
affiliation: Zimmer Biomet
name: Hillary Overholser, MS
role: STUDY_DIRECTOR
References: