Clinical trial NCT05548972: G7 Dual Mobility With Vivacit-E or Longevity PMCF
Official title: Global, Multicenter and Prospective Post-Market Clinical Follow-Up Study of the G7® Dual Mobility Acetabular System With Vivacit-E® or Longevity® Poly Bearing & Instrumentation
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hip Osteoarthritis
Rheumatoid Arthritis
Joint Diseases
Avascular Necrosis
Dislocation, Hip
Femoral Neck Fractures
Trochanteric Fractures
Revision Surgeries
Keywords: Total Hip arthroplasty
Revision Hip arthroplasty
Medical device
Safety
Performance
Clinical benefit
G7 Dual Mobility
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2022-09-22
Enrollment: 358
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a global, multi-center, prospective, non-controlled, non-randomized, post-market clinical follow-up study. The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Dual Mobility Acetabular System when used with the Vivacit-E or Longevity polyethylene hip bearing and instrumentation in primary total and revision (total) hip arthroplasty

Detailed description: The G7 Dual Mobility construct offers dislocation resistance without the need to constrain the femoral head, providing stability and high range of motion. Dual Mobility systems decrease the risk of post-operative instability in high-risk patients in both primary and revision arthroplasties.

This study will enroll up to 358 hips globally, 179 for the Vivacit-E and 179 for the Longevity polyethylene bearings. From the 179 hips per bearing variant, the study will enroll 60 primary and 119 revision arthroplasty hips. The Longevity bearing variant will only be enrolled in the US, as it is not CE marked and unregistered in the APAC market. Vivacit-E bearings will be enrolled globally.

A maximum of 20 study centers will be selected globally. To minimize potential bias and to maximize our ability to assess inter-site differences, each study site will target maximum 24 primary hip arthroplasties and maximum 47 revision hip arthroplasties. Each site is encouraged to enroll both, primary and revision, subjects.

Eligibility criteria: Inclusion Criteria:

* Patient is 18 to 80 years of age, inclusive
* Patient is skeletally mature
* Patient qualifies for (total) hip arthroplasty based on physical exam and medical history including at least one of the following:

  * Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
  * Rheumatoid arthritis
  * Dislocation risks
  * Correction of functional deformity
  * Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
  * Revision procedures where other treatment or devices have failed.
* Patient is willing and able to complete scheduled follow-up evaluations as described in the protocol and Informed Consent
* Patient, or the patient's legally authorized representative (LAR), has participated in the Informed Consent process and is willing and able to sign an IRB/EC approved Informed Consent

Exclusion Criteria:

* Patient is septic, has an active infection or has osteomyelitis at the affected joint
* Patient has significant osteoporosis as defined by treating surgeon
* Patient has metabolic disorder(s) which may impair bone formation
* Patient has osteomalacia
* Patient has distant foci of infections which may spread to the implant site
* Patient has rapid joint destruction, marked bone loss or bone resorption apparent on pre-operative radiographs
* Patient underwent contralateral THA within 3 months of planned index procedure or has a contralateral THA planned within 3 months of the index procedure
* Patient is undergoing simultaneous bilateral THA
* Patient has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which are likely to jeopardize the outcome of the surgery.
* Patient has any concomitant disease which is likely to jeopardize the functioning or success of the implant
* Patient is known to be pregnant
* The patient is in a vulnerable population group such as:

  * a prisoner
  * a known alcohol or drug abuser
  * mentally incompetent or unable to understand what participation in this study entails

Primary outcomes:
measure: Survival of the implant system
timeFrame: 10 years
measure: Safety of the implant system
timeFrame: 10 years
Secondary outcomes:
measure: Modified Harris Hip Score
timeFrame: 10 years
measure: Oxford Hip Score
timeFrame: 10 years
measure: EQ-5D-5L
timeFrame: 10 years
measure: Radiographic Assessment
timeFrame: 5 years
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Bowen Hefley Orthopedics
state: Arkansas
city: Denver
country: United States
facility: HCA HealthONE Orthopedic Specialists
state: Colorado
city: Jersey City
country: United States
facility: Jersey City Medical Center
state: New Jersey
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Eugene
country: United States
facility: Slocum Research & Education Foundation
state: Oregon
city: Leuven
country: Belgium
facility: UZ Leuven
city: Milano
country: Italy
facility: Istituto San Siro
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangnam
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanam-do
Study officials:
affiliation: Zimmer Biomet
name: Hassan Achakri
role: STUDY_DIRECTOR
References: