Radiographic Stability of Hip Prosthesis Prior to Revision Surgery
NCT ID: NCT06924567
Last Updated: 2025-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
600 participants
OBSERVATIONAL
2025-05-31
2028-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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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.
Implant motion provocation CT
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,
Interventions
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Implant motion provocation CT
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,
Eligibility Criteria
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Exclusion Criteria
Instability with repeating dislocation of the THA Non-aseptic revision surgery, based on preoperative work up. Participants are excluded after inclusion if revision surgery is cancelled.
ALL
No
Sponsors
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Sectra AB, Sweden
UNKNOWN
Georgios Tsikandylakis, MD PhD
OTHER
Responsible Party
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Georgios Tsikandylakis, MD PhD
MD, PhD
Principal Investigators
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Henrik Malchau, MD, PhD
Role: STUDY_CHAIR
Sahlgrenska University Hospital
Georgios Tsikandylakis
Role: PRINCIPAL_INVESTIGATOR
Sahlgrenska University Hospital
Locations
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Sahlgrenska University Hospital
Gothenburg, , Sweden
Hässleholm Hospital
Hässleholm, , Sweden
Danderyd Hospital
Stockholm, , Sweden
Akademiska University Hospital
Uppsala, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Maziar Mohaddes, MD, PhD
Role: primary
Olof Sköldenberg, MD, PhD
Role: primary
References
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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.
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.
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.
Other Identifiers
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284803
Identifier Type: -
Identifier Source: org_study_id
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