Trials / Enrolling By Invitation
Enrolling By InvitationNCT05587244
G7 Freedom Constrained Vivacit-E Liners
Multicenter, Prospective Post-Market Clinical Follow-Up Study of the G7® Freedom Constrained Vivacit-E® Liners
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 202 (estimated)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Osteoarthritis, Hip
- Rheumatoid Arthritis
- Non-Union Fracture
- Trochanteric Fractures
- Femoral Neck Fractures
- Avascular Necrosis
- Dislocation, Hip
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Total Hip Arthroplasty with G7 Freedom Constrained Vivacit-E Liners | Primary and/or Revision total hip arthroplasty with the G7 Freedom Constrained Vivacit-E Liners |
Timeline
- Start date
- 2023-05-08
- Primary completion
- 2037-12-01
- Completion
- 2038-12-01
- First posted
- 2022-10-20
- Last updated
- 2025-10-20
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05587244. Inclusion in this directory is not an endorsement.