Calibration Sheet: A prospective Study: Comparing a dual position calibration marker with a mono marker

• Conditions: Radiographs of the pelvis are analyzed regarding calibration markers.

• Registration Number: DRKS00012844
• Lead Sponsor: Klinik für Orthopädie & UnfallchirurgieUniversitätsklinikum Köln (AöR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-09
• Study Completion: 2019-09-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

THA with known implants
- Unilateral THA
- Low pelvic radiograph
- Mono marker
- Informed consent given
- Heigth and weight documented (ORBIS/Akte)

Exclusion Criteria

- Incomplete Information on THA head size
- Technical incorrect radiograph (following Standard rules)
- External radiographs (imported radiographs from other sources)
- Missing external markers
- obviously malpositioned external marker
- No consent given
- Incomplete documentation
- anatomical deformities of the pelvis
e.g.
• Bone tumors
• Anatomical variations
• Postoperative changes (except for THA)
• Fractures of the pelvis (new/old)
• Foreign material in the pelvis (except for THA/Markers)
-Markers not completely visible dur to foreign material
-Radiographs taken in bed or under restrictions impeding correct radiographs to be taken

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of the projected diameters of<br>Mono-Marker<br>Dual position maker<br>Internal Marker<br><br>Comparison of external markers regarding the agreement with internal marker (Gold-Standard)<br><br>Note: Sample size is 100 (Standing)<br><br>One arm, <br> - 100 patients standing upright<br><br>Timing: Radiographs are taken during regular follow-ups after total hip replacement. Usually 3-7 days, 6-12 weeks and 6-12 months after surgery.<br><br>Digital measurements are performed after the radiographs are taken by the investigator.<br><br>The questionnaire should be answered immidiately after the radiograph was taken.<br><br>Amendment 05 Oct 2019:<br>A secondary independent arm of 100 radiographs in supine position was not enrolled due to the low expected number of supine radiographs due to the institutional standards (standing x-ray).<br>(s.a. Update von 08/2018)

Secondary Outcome Measures

Name	Time	Method
Questionnaire regarding both markers after the radiograph.<br><br>The questionnaire was specifically designed for the study.<br>It asks about comfort of both marker types and direct comparison. Three questions.