G7 Dual Mobility With Vivacit-E or Longevity PMCF

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05548972
• Other study ID #: CMG2020-42H
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: August 2037

Study information

• Verified date: February 2024
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 358
• Est. completion date: August 2037
• Est. primary completion date: January 2037
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Avascular Necrosis
• Dislocation, Hip
• Femoral Neck Fractures
• Fractures, Bone
• Hip Dislocation
• Hip Fractures
• Hip Osteoarthritis
• Joint Diseases
• Necrosis
• Osteoarthritis, Hip
• Rheumatoid Arthritis
• Trochanteric Fractures

Intervention

Device:
• G7 Dual Mobility with Vivacit-E bearing
hip arthroplasty with G7 Dual Mobility Vivacit-E bearing
• G7 Dual Mobility Longevity bearing
hip arthroplasty with G7 Dual Mobility Longevity bearing

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven
Italy	Istituto San Siro	Milano
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun	Jeollanam-do
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeongsangnam
United States	Slocum Research & Education Foundation	Eugene	Oregon
United States	Jersey City Medical Center	Jersey City	New Jersey
United States	Bowen Hefley Orthopedics	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

United States,  Belgium,  Italy,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival of the implant system	Survival of the implant system based on removal of the study device	10 years
Primary	Safety of the implant system	Safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.	10 years
Secondary	Modified Harris Hip Score	The modified Harris Hip Score measures pain, function and functional activities using a self assessment. The overall score runs from 0-100 with 100 representing the best outcome.	10 years
Secondary	Oxford Hip Score	The Oxford Hip Score measures pain and function using a self assessment. The overall score runs from 0-48 with 48 representing the best outcome.	10 years
Secondary	EQ-5D-5L	The EQ-5D-5L measures the quality of life using a self assessment. The questionnaire includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.	10 years
Secondary	Radiographic Assessment	X-ray evaluation to find significant radiographic findings such as radiolucency, osteolysis, atrophy, hypertrophy, component migration, device fracture, heterotopic ossification, etc	5 years