G7 Dual Mobility System Used in Total Hip Arthroplasty for the Treatment of Femoral Neck Fracture

Zimmer Biomet

Status: Active, not recruiting

Conditions: Hip Fractures

Treatments: Device: G7 Acetabular System

Study type: Observational

Funder types: Industry

Identifiers

NCT04031209

CSA2019-02H

Details and patient eligibility

About

This is a retrospective and prospective, multi-center, non-comparative, post market clinical follow-up study involving orthopedic surgeons skilled in THA and experienced implanting the devices included in this study.

Full description

The objectives of the study are to document the performance and safety of the G7 Dual Mobility System when used in primary total hip arthroplasty for the treatment of femoral neck fracture by analysis of standard scoring systems, radiographs, revision and adverse event records.The study will include a maximum of 15 centers and up to 300 implanted hips. Each center may enroll up to a maximum of 40 hips to permit the consistency of outcomes across a variety of investigators and clinical setting

Enrollment: 275 patients

Sex: All

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 55 to 80 years of age, inclusive
• Skeletally mature
• Have undergo treatment or in need of primary THA treatment of non-union, femoral neck fracture, unmanageable by other techniques
• Have G7 Dual Mobility system implanted or decision to have a G7 Dual Mobility system implanted was made independently and prior to recruitment into study
• Willing and able to complete scheduled follow-up evaluations as described in the study protocol
• Has participated in the Informed Consent process and is willing and able to sign an IRB/EC approved informed consent

Exclusion criteria

• Is septic, has an active infection or has osteomyelitis at the affected joint
• Has significant osteoporosis as defined by treating surgeon
• Has metabolic disorder(s) which may impair bone formation
• Has osteomalacia
• Has distant foci of infections which may spread to the implant site
• Has rapid joint destruction, marked bone loss or bone resorption on pre-operative radiographs
• Has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery
• Has any concomitant disease which is likely to jeopardize the functioning or success of the implant
• Is known to be pregnant
• Is a prisoner, known alcohol or drug abuser or mentally incompetent or unable to understand what participation in this study entails
• Has a known sensitively or allergy to one or more of

Trial design

275 participants in 1 patient group

G7 G7 Acetabular System

Description:

All patients will receive G7 G7 Acetabular System

Treatment:

Device: G7 Acetabular System