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This is a multicentre post-marketing prospective study to evaluate performance and clinical outcomes of AMIIStem primary hip system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMIStem Hip System | Other | Patients who comply with the protocol and received an AMIStem femoral component. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMIStem Hip System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of implant survivorship using Kaplan Meier curve | 10 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the patient's physical level of activity using the Oxford Hip Score | pre-op, annually post-op up to 10 years | |
| Assessment of the improvement in quality of life and joint movement using the EuroQol-5D score | pre-op, annually post-op up to 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard E Field, PhD FRCS | British Orthopaedic Association | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uniklinik Balgrist | Zurich | 8008 | Switzerland | |||
| The Elective Orthopaedic Centre (EOC) |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D010020 | Osteonecrosis |
| D006618 | Hip Dislocation, Congenital |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D001847 | Bone Diseases |
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| Assessment of implant survivorship as a measure of safety using Kaplan Meier curve | 6 months, 3 years, 5 years, 7.5 years, 10 years after surgery |
| Assessment of the clinical outcome following total hip replacement using the Harris Hip Score | pre-op, 6 months, 3 years, 5 years, 7.5 years, 10 years after surgery |
| Epsom |
| Surrey |
| KT18 7EG |
| United Kingdom |
| D009336 |
| Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000082602 | Developmental Dysplasia of the Hip |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |