Clinical trial NCT06924567: Radiographic Stability of Hip Prosthesis Prior to Revision Surgery
Official title: The Accuracy of CT-based Implant Movement for the Evaluation of Cup and Stem Stability, When Plain Radiography is Not Conclusive for Loosening, in Patients Scheduled for Revision Hip Arthroplasty. A Multicenter Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Loosening, Prosthesis
Hip Arthropathy
Keywords: implant stabilty
THA
radiographic evaluation
IMA
Implant Movement Analysis
Revision THA
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Sectra AB, Sweden
First posted: 2025-04-11
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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 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: 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.

Primary outcomes:
measure: Cup and stem stability
timeFrame: within 2 months month
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Hässleholm
country: Sweden
facility: Hässleholm Hospital
city: Stockholm
country: Sweden
facility: Danderyd Hospital
city: Uppsala
country: Sweden
facility: Akademiska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Henrik Malchau, MD, PhD
role: STUDY_CHAIR
affiliation: Sahlgrenska University Hospital
name: Georgios Tsikandylakis
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.