Prospective G7 Dual Mobility Total Hip PMCF

Safety Clinical Trial

Official title:

Prospective Multi-Center Clinical Evaluation Following Total Hip Arthroplasty With the G7 Dual Mobility System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03308929
• Other study ID #: H.CR.I.G.16.5
• Status: Active, not recruiting
• Start date: February 28, 2017
• Est. completion date: February 28, 2029

Study information

• Verified date: September 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: February 28, 2029
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Clinical Outcomes
• Functional Outcomes
• Radiological Outcomes
• Safety
• Survivorship

Intervention

Device:
• G7 Dual Mobility hip
Total hip arthroplasty and implantation of the G7 device

Locations

Country	Name	City	State
United States	New Mexico Orthopaedics	Albuquerque	New Mexico
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Tidewater Orthopaedics	Hampton	Virginia
United States	Jersey City Medical Center	Jersey City	New Jersey
United States	Oregon Health and Science University	Portland	Oregon
United States	Ortho Virginia	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survivorship of the study device	This is assessed by removal of the study device from the patient for any reason, including failure of the device, infection, or traumatic injury.	5 years
Secondary	Radiographic measurements of the implanted device	Standard AP radiographs of implanted hip will assess the positioning of the device as well as lucencies and other potential anomalies.	10 years
Secondary	Frequency and incidence of adverse events for all subjects with particular focus on those related or potentially related to the device	Assessed by tracking the type of adverse event, severity and relation of the event(s) to the study device	10 years
Secondary	Patient Physical Activity	UCLA activity score - patient self assessment	10 years
Secondary	Patient Quality of Life	EQ-3L-5D quality of life measure - patient self assessment	10 years
Secondary	Harris Hip Score	Harris Hip score measures pain, function, absence of deformity, and range of motion. Scores range from 0-100 with higher scores representing less dysfunction and better outcomes	10 years