Clinical trial NCT05587244: G7 Freedom Constrained Vivacit-E Liners
Official title: Multicenter, Prospective Post-Market Clinical Follow-Up Study of the G7® Freedom Constrained Vivacit-E® Liners
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Osteoarthritis, Hip
Rheumatoid Arthritis
Non-Union Fracture
Trochanteric Fractures
Femoral Neck Fractures
Avascular Necrosis
Dislocation, Hip
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2022-10-20
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multicenter, Prospective, Non-controlled, Non-randomized, Consecutive series of patients, two cohort study
Primary purpose: TREATMENT

Brief summary: The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Freedom Constrained Vivacit-E Acetabular Liners in primary and revision total hip arthroplasty.

Detailed description: The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Freedom Constrained Vivacit-E Acetabular Liners in primary and revision total hip arthroplasty.

The primary endpoint is defined by the survival of the implant system at 10 years, which is based on removal of the study device and will be determined using the Kaplan-Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to the implant, instrumentation and/or procedure should be specified.

The secondary endpoints are the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs) as well as radiographic outcomes (if available).

The G7 Vivacit-E Freedom Constrained Liner is indicated for use (per IFU) as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.

Eligibility criteria: Inclusion Criteria:

* Patient is 18 to 80 years of age, inclusive
* Patient is skeletally mature
* Patient qualifies for unilateral 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
  * High risk for dislocation
  * Undergoing revision hip arthroplasty
  * Correction of functional deformity
  * In need of treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
* 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, has participated in the Informed Consent process and is willing and able to sign an IRB 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 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 might jeopardize the outcome of the surgery.
* In the opinion of the investigator, 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 the 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 study device
timeFrame: 10 years
Secondary outcomes:
measure: Incidence of treatment-emergent Adverse Events (safety)
timeFrame: 10 years
measure: Pain and Functional Performance - Modified Harris Hip Score
timeFrame: 10 years
measure: Pain and Functional Performance - Oxford Hip Score
timeFrame: 10 years
measure: Euroqol Patient Quality of life measured at 2 years follow-up (EQ-5D-5L)
timeFrame: 10 Years
measure: Radiographic Performance evaluating radiolucency at 5 years follow-up
timeFrame: 5 Years
measure: Radiographic Performance evaluating osteolysis at 5 years follow-up
timeFrame: 5 Years
measure: Radiographic Performance evaluating atrophy/hypertrophy at 5 years follow-up
timeFrame: 5 Years
measure: Radiographic Performance evaluating component migration at 5 years follow-up
timeFrame: 5 Years
measure: Radiographic Performance evaluating device fracture at 5 years follow-up
timeFrame: 5 Years
measure: Radiographic Performance evaluating heterotopic ossification at 5 years follow-up
timeFrame: 5 Years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Gainesville
country: United States
facility: University of Florida Board of Trustees
state: Florida
city: Livingston
country: United States
facility: Jersey City Medical Center, Inc
state: New Jersey
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Knoxville
country: United States
facility: TOA Research Foundation
state: Tennessee
city: Houston
country: United States
facility: The University of Texas Health Science Center of Houston
state: Texas
city: Plano
country: United States
facility: Medical City Plano
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: Zimmer Biomet
name: Hillary Overholser
role: STUDY_DIRECTOR
References: