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The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available G7 BiSpherical Acetabular Shell.
The G7 BiSpherical Acetabular Shell belongs to the G7 multi-bearing platform. It was developed to provide an additional surgical option for patients in need of a total hip replacement. The aim of the G7 BiSpherical Acetabular Shell is to increase hip function while reducing pain.
This study is a multicenter, prospective, non-randomized, non-controlled post market surveillance study involving orthopedic surgeons skilled in hip arthroplasty procedures. A minimum of 4 and a maximum of 5 sites will be involved in this study. This number of clinical centers will permit assessment of consistency among a multitude of investigators. 140-175 implants will be included into the study. Each site will be allowed to enroll 35 patients. All potential study subjects will be required to participate in the Informed Consent Process.
The safety and performance of the G7 BiSpherical Acetabular Shell will be assessed as following: implant survivorship based on revision with removal of the study device; safety based on incidence and frequency of adverse events; and clinical efficacy measured by overall pain and function, quality of life data and radiographic evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who received the G7 BiSpherical Cup | Subject in need of a THA who met the inclusion/exclusion criteria and received the G7 BiSpherical cup. |
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| Measure | Description | Time Frame |
|---|---|---|
| Implant survivorship is assessed counting the number of implant revisions | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical efficacy of the device is assessed using the Oxford Hip Score patient questionnaire | 10 years | |
| Clinical efficacy of the device is assessed using the Harris Hip Score patient questionnaire | 10 years |
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Inclusion Criteria:
Inclusion criteria specific for patients receiving the G7 BiSpherical Shell with the G7 Freedom Constrained Liner:
Exclusion Criteria:
Absolute exclusion criteria include:
Relative exclusion criteria include:
Exclusion criteria specific for patients receiving the G7 BiSpherical Shell with the G7 Freedom Constrained Liner:
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Patients in need of a Total Hip Arthroplasty (primary or revision) which receive the G7 BiSperical Acetabular Shell and who meet all of the inclusion and none of the exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Hassan Achakri | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabinet du Dr. Miazzolo | Perpignan | 66000 | France | |||
| Orthopädische Chirurgie Müchen OCM |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D010003 | Osteoarthritis |
| D010020 | Osteonecrosis |
| D005599 | Fractures, Ununited |
| D005265 | Femoral Neck Fractures |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Safety is assessed according to the number of complications which are collected via adverse event forms. | 10 years |
| Munich |
| Bavaria |
| 81369 |
| Germany |
| Herzogin Elisabeth Hospital | Braunschweig | Lower Saxony | 38124 | Germany |
| Reinier de Graaf Groep | Delft | Netherlands |
| Orthoprax AG | Bern | 3012 | Switzerland |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D005264 | Femoral Fractures |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |