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| Name | Class |
|---|---|
| JRI Orthopaedics Ltd | INDUSTRY |
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The aim of this study is to further investigate the clinical and radiological importance of design changes in cementless hip prosthesis. The investigators have earlier evaluated the classical Furlong HAC total hip prosthesis and a first design change Furlong Active. Now a further development, Furlong Evolution, is to be evaluated. This prosthesis, furthermore, comes with and without a collar, and the investigators are going to randomize between the two. The investigators hypothesize that the new design will be easier to implant and will present equal or less migration than the older designs which would imply a favourable outcome in the long term. The investigators further hypothesize that the collar play no major part for the long term migration and bone remodelling.
We will now do a 10 year follow up of the patients including RSA, DXA and PROMS
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem collar | No Intervention | The stem has two versions, one with and one without a collar. This arm will have stems with a collar. The classical Furlong HAC had a collar. | |
| No Stem collar | Active Comparator | The stem has two versions, one with and one without a collar. This arm will have stems without a collar. The classical Furlong HAC had a collar. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stem collar | Procedure | The stem has two versions, one with and one without a collar. The classical Furlong HAC had a collar. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiostereometric Analysis (RSA) | This will measure the change in migration (translation and rotation around the x-, y-, and z-axis of the hip) over time. The migration pattern the first 2 years can predict the long term outcome. | The first postoperative day, 14 days, 3 months, 1, 2, 5 and 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Dual-energy X-ray absorptiometry (DXA) | This will measure the change in bone density around the prosthesis during the first important year. This will tell if there is a bone resorption around the stem or cup. | 14 days postoperatively and after 1, 5 and 10 years |
| General health questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gunnar Flivik, MD PhD | Dept of Orthopedics, Skane University Hospital, Lund University, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopedics, Skane University Hospital, Lund University | Lund | Skåne County | 221 85 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34841462 | Derived | Belfrage O, Weber E, Sundberg M, Flivik G. Preserved periprosthetic bone stock at 5 years post-operatively with uncemented short hip stem in both collared and collarless version. Arch Orthop Trauma Surg. 2022 Nov;142(11):3489-3496. doi: 10.1007/s00402-021-04225-z. Epub 2021 Nov 29. |
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EuroQol (EQ-5D) - a standardized instrument for use as measure of general health outcome over time |
| Preoperatively (3-4 weeks) and 1, 2, 5 and 10 years postoperatively |
| Hip specific health questionnaire | Hip disability and Osteoarthritis Outcome Score (HOOS) - this is a hip specific questionnaire that will measure how the operation has affected the patients function and pain situation. | Preoperatively (3-4 weeks) and 1, 2, 5 and 10 years postoperatively |