Radiographic Stability of Hip Prosthesis Prior to Revision Surgery (MULTICIMA)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hip Arthropathy; Loosening, Prosthesis
• Intervention / Treatment: Diagnostic test: Implant motion provocation CT

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Linda Andersson, BMA; Phone Number: 0762756531; Email: linda.mr.andersson@vgregion.se

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Hvidovre Hospital
    • Contact: Anders Troelsen, PhD; Phone Number: +45 38 62 67 74; Email: Anders.Troelsen@regionh.dk
• Norway
  • Oslo, Norway
    • Oslo University Hospital
    • Contact: Stephan M Röhrl, PhD; Phone Number: +47 22 22 09 87; Email: s.m.rohrl@medisin.uio.no
• Sweden
  • Gothenburg, Sweden, 41345
    • Sahlgrenska University Hospital
    • Contact: Linda Andersson, BMA; Phone Number: 0046762756531; Email: linda.mr.andersson@vgregion.se
    • Principal Investigator: Georgios Tsikandylakis, MD, PhD
    • Sub-Investigator: Raéd Itayem, MD, PhD
  • Hässleholm, Sweden
    • Hässleholm Hospital
    • Contact: Maziar Mohaddes, MD, PhD
    • Principal Investigator: Maziar Mohaddes, MD, PhD
  • Stockholm, Sweden
    • Danderyd Hospital
    • Principal Investigator: Olof Sköldenberg, MD, PhD
    • Contact: Olof Sköldenberg, MD, PhD
  • Uppsala, Sweden
    • Akademiska University hospital
    • Contact: Cyrus Brodén, MD, PhD; Email: cyrus.broden@akademiska.se
    • Principal Investigator: Cyrus Brodén, M, PhDD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	within 2 months month

Collaborators and Investigators

• Sponsor: Georgios Tsikandylakis, MD PhD
• Collaborators: Sectra AB, Sweden
• Investigators: Study Chair: Henrik Malchau, MD, PhD, Sahlgrenska University Hospital; Principal Investigator: Georgios Tsikandylakis, Sahlgrenska University Hospital

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: April 5, 2025
• First Submitted That Met QC Criteria: April 5, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: THA; IMA; radiographic evaluation; implant stabilty; Implant Movement Analysis; Revision THA
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Prosthesis Failure
• Other Study ID Numbers: 284803

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No