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The purpose of this study is to evaluate the survivorship (revision rates) and patient reported outcomes (PROMs) following implantation of the Insignia hip stem in patients undergoing cementless total hip replacement surgery compared to currently available stems used for the same type of surgery.
It is hypothesised the 2-year survivorship of the Insignia stem is noninferior to the benchmark survivorship of similar stems used in the same type of surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Insignia hip stem study group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hip stem prosthesis | Device | The Insignia hip stem prosthesis will be used in cementless total hip replacement surgery (THA). The surgery typically takes approximately two hours. All study participants will receive the Insignia hip stem and compatible components. Experienced Orthopaedic Surgeons trained in THA will perform the surgeries as per the standard surgical technique guide for this prosthesis. |
| Measure | Description | Time Frame |
|---|---|---|
| Implant survivorship | Implant survivorship using cumulative percent revision (CPR) of the Insignia hip stem, for any reason. | 2 years post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Hip Score | Performance of the Insignia hip stem using Oxford Hip Score (OHS) in the intervention group | Pre-operatively and 6 months, 12 months and 2 years post-operatively |
| Hip Disability and Osteoarthritis Outcome Score (HOOS-12). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Holly Solomon | Contact | +61405307762 | holly.solomon@stryker.com |
| Name | Affiliation | Role |
|---|---|---|
| Gavin Clark, MD | Perth Hip and Knee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St John of God Subiaco Hospital | Recruiting | Subiaco | Western Australia | 6008 | Australia |
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|
Function, pain and satisfaction in the intervention group using the Hip Disability and Osteoarthritis Outcome Score mid-version (HOOS-12). This is a composite measure.
| Pre-operatively and 6 months, 12 months and 2 years post-operatively |
| EQ-5D-5L | Function, pain and satisfaction in the intervention group using EQ-5D-5L domains and EQ (Visual analogue scale) VAS. This is a composite measure. | Pre-operatively and 6 months, 12 months and 2 years post-operatively |
| Hip and lower back pain VAS | Hip and lower back pain in the intervention group using a VAS. This is a composite measure. | Pre-operatively and 6 months, 12 months and 2 years post-operatively |
| Forgotten Joint Score (FJS) | Function, pain and satisfaction in the intervention group using Forgotten Joint Score (FJS). This is a composite measure. | Pre-operatively and 6 months, 12 months and 2 years post-operatively |
| Complications | Post-operative complications when the Insignia Hip Stem is used in THA in the intervention group.. | Collected as they arise post-operatively. Reported as number within 6 months, 12 months and 2 years post-operatively. |
| Mortality | Mortality in the intervention group | 1 and 2 years post-operatively |
| CPR for stem loosening | CPR of the Insignia Hip Stem for stem loosening in the intervention group | 2 years post-operatively |
| Femoral fracture | Insignia Hip Stem device-related femoral fracture in the intervention group | 2 years post-operatively |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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