MedTrace Logo

Radiographic Stability of Hip Prosthesis Prior to Revision Surgery

NCT06924567 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2026-03-12

No results posted yet for this study

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

Conditions

  • Loosening, Prosthesis
  • Hip Arthropathy

Interventions

DIAGNOSTIC_TEST

Implant 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,

Sponsors & Collaborators

  • Sectra AB, Sweden

    collaborator UNKNOWN

  • Georgios Tsikandylakis, MD PhD

    lead OTHER

Principal Investigators

  • Henrik Malchau, MD, PhD · Sahlgrenska University Hospital

  • Georgios Tsikandylakis · Sahlgrenska University Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-15
Primary Completion
2029-12-31
Completion
2029-12-31
FDA Device
Yes

Countries

  • Denmark
  • Norway
  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06924567 on ClinicalTrials.gov