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The final assessments were conducted late and in a reduced format due to resource limitations at the site.
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The purpose of this study is to compare the performance of 4 designs of the DePuy Ultima LX hip stem in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to one of the 4 designs of the DePuy Ultima LX hip stem and will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1) Ultima LX Collared Stem - Non-Polished/Blasted Finished | Active Comparator | A collared non-polished blasted finished cementless femoral component for use in total hip replacement. |
|
| 2) Ultima LX Collared Stem - Polished Finished | Active Comparator | A collared polished finished cementless femoral component for use in total hip replacement. |
|
| 3) Ultima LX Collarless Stem - Non-Polished/Blasted Finished | Active Comparator | A collarless non-polished/blasted finished cementless femoral component for use in total hip replacement. |
|
| 4) Ultima LX Collarless Stem - Polished Finished | Active Comparator | A collarless polished finished cementless femoral component for use in total hip replacement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultima LX Collared Stem - Non-Polished/Blasted Finished | Device | A collared non-polished/blasted finished cementless femoral component for use in total hip replacement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stem movement measured radiographically at 2 years | Stem movement was measured radiographically by comparing baseline stem position with the stem position 2 years after surgery. If migration was observed to be 5 or more mm, it was considered clinically significant migration. | 2yrs post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Comparisons of Visual Analog Pain (VAS), 36-Item Short Form Health Survey (SF-36), Satisfaction, Limb Length and stem movement measured radiographically at 5 years. | The following outcome measures were used; VAS Pain score, SF36 Patient reported outcome, Satisfaction, Limb Length physical examination, and stem movement measured radiographically. | 5yrs post-surgery |
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Inclusion Criteria:
Current indications for primary total hip arthroplasty utilising a cemented femoral component. These include pain, deformity and loss of function which are not responsive to medical treatment
Exclusion Criteria:
i) Revision Total Hip Arthroplasty ii) Rheumatoid arthritis iii) Age greater than 80 years at time of surgery iv) Age less than 60 years at time of surgery v) Previous hip joint sepsis vi) Obesity vii) Patient likely to remain housebound once rehabilitation is complete
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Epsom General Hospital | Surrey | KT18 7EG | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24474088 | Result | Hutt J, Hazlerigg A, Aneel A, Epie G, Dabis H, Twyman R, Cobb A. The effect of a collar and surface finish on cemented femoral stems: a prospective randomised trial of four stem designs. Int Orthop. 2014 Jun;38(6):1131-7. doi: 10.1007/s00264-013-2256-z. Epub 2014 Jan 29. |
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| Ultima LX Collared Stem - Polished Finished | Device | A collared polished finished cementless femoral component for use in total hip replacement. |
|
| Ultima LX Collarless Stem - Non-Polished/Blasted Finished | Device | A collarless non-polished/blasted finished cementless femoral component for use in total hip replacement. |
|
| Ultima LX Collarless Stem - Polished finished | Device | A collarless polished finished cementless femoral component for use in total hip replacement. |
|
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D003095 | Collagen Diseases |
| D010020 | Osteonecrosis |
| D006618 | Hip Dislocation, Congenital |
| D060048 | Slipped Capital Femoral Epiphyses |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001847 | Bone Diseases |
| 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 |
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D004839 | Epiphyses, Slipped |
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