Radiographic Stability of Hip Prosthesis Prior to Revision Surgery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorGeorgios Tsikandylakis, MD PhD
About this trial
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
Eligibility criteria
Qualifiers
Patient scheduled for revision THA due to aseptic loosening.
One component (cup or stem) has no convincing loosening signs, based on the preoperative plain radiographs and clinical assessment by the attending surgeon.
Radiographs not older than 8 weeks prior to surgery.
Disqualifiers
Both cup and stem have been preoperatively evaluated as loose
Instability with repeating dislocation of the THA
Non-aseptic revision surgery, based on preoperative work up.
The scheduled revisionsurgery is cancelled.
Trial design
Treatments tested in this trial
- Implant motion provocation CT
Treatment groups
600 Participants
are divided into 1 treatment groupSponsors and collaborators
Georgios Tsikandylakis, MD PhD
Lead sponsor
Sahlgrenska University Hospital
Sponsor institution
Sectra AB, Sweden
Collaborator
Source ClinicalTrials.gov