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
This trial does not accept healthy volunteersQualifiers
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 population
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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Implant motion provocation CT
Diagnostic testImplant 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,
Treatment groups
600 Participants
are divided into 1 treatment groupGroup A: Study group1 intervention
Trial outcomes
Primary outcomes
1
Cup and stem stability
The stability of the cup and the stem is evaluated: 1. Preoperatively with IMA as binary outcome (loose/not loose). 2. Intraoperatively by the surgeon as binary outcome (loose/notloose).
Time frame
within 2 months monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Georgios Tsikandylakis, MD PhD
Lead sponsor
Sahlgrenska University Hospital
Sponsor institution
Sectra AB, Sweden
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: