Radiographic Stability of Hip Prosthesis Prior to Revision Surgery

NCT06924567 | Not Yet Recruiting FDA Device

• 1 other identifier: 284803
• Study Type: observational
• Target: 600
• Locations: 3 countries
• Sites: 6

Brief 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

Keywords

implant stabilty; THA; radiographic evaluation; IMA; Implant Movement Analysis; Revision THA

Outcome Measures

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).

  within 2 months month

Study Arms (1)

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

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,

Study group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Georgios Tsikandylakis, MD PhD: lead
• Sectra AB, Sweden: collaborator

Study Sites (6)

Hvidovre Hospital

Copenhagen, Denmark

Location

Oslo University Hospital

Oslo, Norway

Location

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Hässleholm Hospital

Hässleholm, Sweden

Location

Danderyd Hospital

Stockholm, Sweden

Location

Akademiska University Hospital

Uppsala, Sweden

Location

Related Publications (3)

• 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.

  PMID: 18622838 BACKGROUND

• 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.

  PMID: 37986000 BACKGROUND

• 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.

  PMID: 36314542 BACKGROUND

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Henrik Malchau, MD, PhD

  Sahlgrenska University Hospital

  STUDY CHAIR

• Georgios Tsikandylakis

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Andersson, BMA

CONTACT

0762756531; linda.mr.andersson@vgregion.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Consultant in Orthopaedics

Study Record Dates

• First Submitted: April 5, 2025
• First Posted: April 11, 2025
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4); NO (1); DK (1)