Loosening, ProsthesisMULTICIMANCT06924567
Radiographic Stability of Hip Prosthesis Prior to Revision Surgery
An observational study of Loosening, Prosthesis and Hip Arthropathy, run by Georgios Tsikandylakis, MD PhD at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Loosening, Prosthesis, Hip Arthropathy
- What is being tested?
- Implant motion provocation CT
- How many people
- 600 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 15 Sep 2026to 31 Dec 2029
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 3 countries
Sweden4 sites
Sahlgrenska University Hospital
Gothenburg, 41345
Linda Andersson, BMA, 0046762756531, linda.mr.andersson@vgregion.se
Georgios Tsikandylakis, MD, PhD
Hässleholm Hospital
Hässleholm
Maziar Mohaddes, MD, PhD
Maziar Mohaddes, MD, PhD
Danderyd Hospital
Stockholm
Olof Sköldenberg, MD, PhD
Olof Sköldenberg, MD, PhD
Akademiska University Hospital
Uppsala
Cyrus Brodén, MD, PhD, cyrus.broden@akademiska.se
Cyrus Brodén, M, PhDD
Denmark1 site
Hvidovre Hospital
Copenhagen
Anders Troelsen, PhD, +45 38 62 67 74, Anders.Troelsen@regionh.dk
Norway1 site
Oslo University Hospital
Oslo
Stephan M Röhrl, PhD, +47 22 22 09 87, s.m.rohrl@medisin.uio.no
About this study
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
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
- Being tested
- Implant motion provocation CT
- Keywords
- implant stabilty, THA, radiographic evaluation, IMA, Implant Movement Analysis, Revision THA
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant motion provocation CTDiagnostic 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,
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Implant motion provocation CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cup and stem stability
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).
Measured: within 2 months month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start15 Sep 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Loosening, ProsthesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Georgios Tsikandylakis, MD PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Sectra AB, Sweden
- Responsible party
- Sponsor-investigator, Georgios Tsikandylakis, MD PhD, Sahlgrenska University Hospital
- Investigators
- Henrik Malchau, MD, PhD, Study chair, Sahlgrenska University HospitalGeorgios Tsikandylakis, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924567
- Sponsor's protocol ID
- 284803
- Acronym
- MULTICIMA
- Status last verified
- Mar 2026
- First submitted
- 5 Apr 2025
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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 18622838Lovera 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 37986000Sandberg 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06924567
- Acronym / sponsor ID
- MULTICIMA / 284803
- Conditions
- Loosening, Prosthesis, Hip Arthropathy
- Keywords
- implant stabilty, THA, radiographic evaluation, IMA, Implant Movement Analysis, Revision THA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Georgios Tsikandylakis, MD PhDUniversity, hospital or other
- Collaborators
- Sectra AB, Sweden
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: Implant motion provocation CTPatients with painful THA, scheduled for reviision hip arthoplasty, with no signs of obvious implant loosening in either the cup or the stem. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implant motion provocation CTImplant 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, | Diagnostic test | Study group |
Primary outcome
Cup and stem stability
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Background: PubMed 18622838Olivecrona 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.
- Background: PubMed 37986000Lovera 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.
- Background: PubMed 36314542Sandberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Henrik Malchau, MD, PhD study chair
Sahlgrenska University Hospital
Georgios Tsikandylakis principal investigator
Sahlgrenska University Hospital
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Loosening, Prosthesis and Hip Arthropathy, run by Georgios Tsikandylakis, MD PhD at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden, Denmark, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linda Andersson, BMA (0762756531, linda.mr.andersson@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cup and stem stability (time frame: within 2 months month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06924567, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.