Radiographic Stability of Hip Prosthesis Prior to Revision Surgery

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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Key information

Conditions

Loosening, Prosthesis Hip Arthropathy Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Failure

Sex eligibility

All sexes

Study type

Observational

Primary location

Hvidovre Hospital, Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implant motion provocation CT

Diagnostic Test

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,

Primary outcomes

Cup and stem stability

Time frame: within 2 months month
The stability of the cup and the stem is evaluated:
- Preoperatively with IMA as binary outcome (loose/not loose).
- Intraoperatively by the surgeon as binary outcome (loose/notloose).

Study contacts

Contact information is provided by the study sponsor or research team.

Linda Andersson, BMA

CONTACT

[email protected]

0762756531

Sponsors and collaborators

Lead sponsor

Georgios Tsikandylakis, MD PhD

Other

Collaborators

Sectra AB, Sweden

Registry information

Official study 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

Acronym: MULTICIMA

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Apr 11, 2025
Registry last updated: Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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