Radiographic Stability of Hip Prosthesis Prior to Revision Surgery

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06924567

Acronym

MULTICIMA

Enrollment

600

Registered

2025-04-11

Start date

2026-09-15

Completion date

2029-12-31

Last updated

2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Arthropathy, Loosening, Prosthesis

Keywords

implant stabilty, THA, radiographic evaluation, IMA, Implant Movement Analysis, Revision THA

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

Interventions

DIAGNOSTIC_TESTImplant 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,

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Cup and stem stability	within 2 months month	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).

Countries

Denmark, Norway, Sweden

Contacts

CONTACTLinda Andersson, BMA

linda.mr.andersson@vgregion.se0762756531

STUDY_CHAIRHenrik Malchau, MD, PhD

Sahlgrenska University Hospital

PRINCIPAL_INVESTIGATORGeorgios Tsikandylakis