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Not yet recruitingNCT06924567MULTICIMAUpdated Mar 12, 2026

Radiographic Stability of Hip Prosthesis Prior to Revision Surgery

An observational study in Loosening, Prosthesis and Hip Arthropathy, sponsored by Georgios Tsikandylakis, MD PhD. Not yet recruiting at 6 sites in 3 countries. Per ClinicalTrials.gov, last updated 2026-03-12.

Sponsored by Georgios Tsikandylakis, MD PhD · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
600
Sex
All
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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

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Conditions studied

  • Loosening, Prosthesis
  • Hip Arthropathy

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Keywords

  • implant stabilty
  • THA
  • radiographic evaluation
  • IMA
  • Implant Movement Analysis
  • Revision THA
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In context

Prosthesis Failure

119 studies on the registry are indexed under Prosthesis Failure; 35 are open to participants now.

This study's planned enrollment of 600 is above the median of 119 across 49 observational studies indexed under Prosthesis Failure.

Browse Prosthesis Failure studies →

Lead sponsor

This is the only study on the registry with Georgios Tsikandylakis, MD PhD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
600 participants (estimated)
Target follow-up
2 Months
Patient registry
Yes

Groups and cohorts

  • Study group

    Patients with painful THA, scheduled for reviision hip arthoplasty, with no signs of obvious implant loosening in either the cup or the stem.

    Diagnostic Test: Implant motion provocation CT

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,

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What researchers measure

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 month

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Study locations

6 sites
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References and documents

Publications

  • 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. PubMed 18622838 ↗
  • 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. PubMed 37986000 ↗
  • 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. PubMed 36314542 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06924567
Lead sponsor
Georgios Tsikandylakis, MD PhD
Collaborators
Sectra AB, Sweden
Responsible party
Georgios Tsikandylakis, MD PhD (Senior Consultant in Orthopaedics, Sahlgrenska University Hospital) — Sponsor-investigator
First posted
Apr 11, 2025
Start date
Sep 15, 2026 (estimated)
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Mar 12, 2026

Study contacts

Linda Andersson, BMA
Contact
linda.mr.andersson@vgregion.se
0762756531
Henrik Malchau, MD, PhD
study chair · Sahlgrenska University Hospital
Georgios Tsikandylakis
principal investigator · Sahlgrenska University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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