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| Name | Class |
|---|---|
| Sectra AB, Sweden | UNKNOWN |
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The goal of this validation study is to compare the preoperative implant stability, assessed by Implant Movement Analysis (IMA), provocation dual CT scans, with the intraoperative stability evaluation in revision hip arthoplasty. The main question it aims to answer is:
Does IMA reflect the intraoperative clinical evaluation of implant stability? Participants scheduled for revision hip arthoplasty will undergo IMA preoperativelly in addition to rutine clinical work up. During revision arthoplasty, a surgeon blinded to the IMA results will assess clinically the stability of the hip prosthesis. IMA will be compared with the intraoperative findings to assess IMAs sensitivity and specificity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Patients with painful THA, scheduled for reviision hip arthoplasty, with no signs of obvious implant loosening in either the cup or the stem. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implant motion provocation CT | Diagnostic Test | Implant Movement Analysis. A low dose CT scan is performed with the hip fixed in external rotation. Then another low dose CT scan is performed with the hip fixed in internal rotation.The CT scans are then overimposed to each other and implant motion in relation to host bone is visualized, |
| Measure | Description | Time Frame |
|---|---|---|
| Cup and stem stability | The stability of the cup and the stem is evaluated:
| within 2 months month |
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Inclusion criteria:
Exclusion criteria:
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Patients with a painful total hip arthoplasty that are scheduled for revision hip arthoplasty due to suspected prosthesis loosening. At least one implant component (either cup or stem) should not have any obvious signs of loosening. Only the implant component with no obvious signs of loosening will be included in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linda Andersson, BMA | Contact | 0762756531 | linda.mr.andersson@vgregion.se |
| Name | Affiliation | Role |
|---|---|---|
| Henrik Malchau, MD, PhD | Sahlgrenska University Hospital | Study Chair |
| Georgios Tsikandylakis | Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hvidovre Hospital | Copenhagen | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18622838 | Background | Olivecrona H, Olivecrona L, Weidenhielm L, Noz ME, Kardos J, Maguire GQ Jr, Zeleznik MP, Aspelin P. A new technique for diagnosis of acetabular cup loosening using computed tomography: preliminary experience in 10 patients. Acta Orthop. 2008 Jun;79(3):346-53. doi: 10.1080/17453670710015247. | |
| 37986000 | Background |
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| ID | Term |
|---|---|
| D011475 | Prosthesis Failure |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Oslo University Hospital | Oslo | Norway |
|
| Sahlgrenska University Hospital | Gothenburg | 41345 | Sweden |
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| Hässleholm Hospital | Hässleholm | Sweden |
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| Danderyd Hospital | Stockholm | Sweden |
|
| Akademiska University Hospital | Uppsala | Sweden |
|
| Lovera D, Sandberg O, Mohaddes M, Gyllensten H. Cost-effectiveness of implant movement analysis in aseptic loosening after hip replacement: a health-economic model. Cost Eff Resour Alloc. 2023 Nov 20;21(1):88. doi: 10.1186/s12962-023-00498-w. |
| 36314542 | Background | Sandberg O, Carlsson S, Harbom E, Cappelen V, Tholen S, Olivecrona H, Wretenberg P. Inducible displacement CT increases the diagnostic accuracy of aseptic loosening in primary total hip arthroplasty. Acta Orthop. 2022 Oct 31;93:831-836. doi: 10.2340/17453674.2022.5240. |