Radiographic Stability of Hip Prosthesis Prior to Revision Surgery

NCT ID: NCT06924567

Last Updated: 2025-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-31

Study Completion Date

2028-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Loosening, Prosthesis Hip Arthropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Implant motion provocation CT

Intervention Type 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,

Interventions

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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,

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Exclusion Criteria

Both cup and stem have been preoperatively evaluated as loose by the attending surgeon, based on the preoperative plain radiographs.

Instability with repeating dislocation of the THA Non-aseptic revision surgery, based on preoperative work up. Participants are excluded after inclusion if revision surgery is cancelled.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sectra AB, Sweden

UNKNOWN

Sponsor Role collaborator

Georgios Tsikandylakis, MD PhD

OTHER

Sponsor Role lead

Responsible Party

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Georgios Tsikandylakis, MD PhD

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Henrik Malchau, MD, PhD

Role: STUDY_CHAIR

Sahlgrenska University Hospital

Georgios Tsikandylakis

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

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Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status

Hässleholm Hospital

Hässleholm, , Sweden

Site Status

Danderyd Hospital

Stockholm, , Sweden

Site Status

Akademiska University Hospital

Uppsala, , Sweden

Site Status

Countries

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Sweden

Central Contacts

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Linda Andersson, BMA

Role: CONTACT

0762756531

Facility Contacts

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Linda Andersson, BMA

Role: primary

0046762756531

Maziar Mohaddes, MD, PhD

Role: primary

Olof Sköldenberg, MD, PhD

Role: primary

Cyrus Brodén, MD, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 18622838 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37986000 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36314542 (View on PubMed)

Other Identifiers

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284803

Identifier Type: -

Identifier Source: org_study_id

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