Status:
NOT_YET_RECRUITING
Radiographic Stability of Hip Prosthesis Prior to Revision Surgery
Lead Sponsor:
Georgios Tsikandylakis, MD PhD
Collaborating Sponsors:
Sectra AB, Sweden
Conditions:
Loosening, Prosthesis
Hip Arthropathy
Eligibility:
All Genders
Brief Summary
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...
Eligibility Criteria
Inclusion
- Inclusion criteria: 600 consecutive patients scheduled for revision THA due to aseptic loosening, in whom, one component has no convincing loosening signs, based on the preoperative plain radiographs and clinical assessment by the attending surgeon. The radiographs should be not older than 8 weeks prior to surgery.
- Exclusion criteria:
- Both cup and stem have been preoperatively evaluated as loose by the attending surgeon, based on the preoperative plain radiographs.
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06924567
Start Date
May 1 2025
End Date
December 1 2028
Last Update
April 11 2025
Active Locations (4)
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1
Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
2
Hässleholm Hospital
Hässleholm, Sweden
3
Danderyd Hospital
Stockholm, Sweden
4
Akademiska University Hospital
Uppsala, Sweden