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| Name | Class |
|---|---|
| Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. | INDUSTRY |
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This is a randomized clinical trial comparing two different uncemented femoral stems and two different uncemented sockets using Dual-energy x-ray absorptiometry, Radiostereometry and clinical evaluation.
Hypothesis:
Consecutive patients 40-70 years old who are being planned for Total Hip Arthroplasty (THA) will be eligible for inclusion in the study.
Periprosthetic bone remodeling, migration of the components and clinical scores will be recorded prospectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hip Arthroplasty, ultra-short stem, conventional cup | Experimental | Hip replacement with a hydroxy-apatite covered ultra-short uncemented femoral stem and a conventional uncemented acetabular cup with hydroxy-apatite covered porous coating and a moderately cross-linked polyethylene cup liner |
|
| Hip Arthroplasty, conventional stem, trabecular-titanium cup | Experimental | Hip replacement with an uncemented tapered femoral stem and an uncemented acetabular cup with trabecular-Titanium backside and E-vitamin-treated polyethylene cup liner |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hip replacement | Procedure | Hip arthroplasty with uncemented components |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone remodelling, i e change in bone mineral density around the stem, as measured with dual energy x-ray absorptiometry (DEXA) | bone mineral density (BMD) measured postoperatively at 2 years. | |
| Bone remodelling, i e change in bone mineral density behind the acetabular component, as measured with dual energy x-ray absorptiometry (DEXA) | bone mineral density (BMD) measured postoperatively at 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Migration of stem components in six degrees of freedom and maximum total point motion measured with radiostereometric analysis (RSA) | at 2 years | |
| Migration of acetabular components in six degrees of freedom and maximum total point motion of the head center measured with radiostereometric analysis (RSA) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome measures with validated scores comparing patients receiving different stems and acetabular components | Validated scores included are Harris Hip Score (HHS), Euroqol 5-dimension (Eq5d) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Self administred validated score outcome measures after 6 weeks, after 3, 6, 12, 24 months and after 6 and 10 years |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Department, Danderyd Hospital | Stockholm | Stockholm County | 18288 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41410176 | Derived | Axenhus M, Salemyr M, Mukka S, Magneli M, Skoldenberg O. Long-term evaluation of periprosthetic bone changes in ultra-short versus conventional stems in total hip arthroplasty: a 10-year follow-up of a randomised controlled trial. Hip Int. 2026 Jan;36(1):55-63. doi: 10.1177/11207000251371283. Epub 2025 Dec 18. |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| at 2 years |
| Migration of acetabular components in six degrees of freedom and maximum total point motion of the head center measured with radiostereometric analysis (RSA) | at 6 and 10 years |
| Bone remodelling, i e change in bone mineral density around the stem and cup, as measured with dual energy x-ray absorptiometry (DEXA) | at 6 and 10 years. |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |