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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00012844

Enrollment

100

Registered

2017-08-09

Start date

2017-10-09

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiographs of the pelvis are analyzed regarding calibration markers.

Interventions

Group 1: Non-interventional study. All probands will wear both markers (mono and dual position marker). This marker will be compared to the internal marker (THA). Questionnaires will be used after the

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Measurement of the projected diameters of Mono-Marker Dual position maker Internal Marker Comparison of external markers regarding the agreement with internal marker (Gold-Standard) Note: Sample size is 100 (Standing) One arm, - 100 patients standing upright 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. Digital measurements are performed after the radiographs are taken by the investigator. The questionnaire should be answered immidiately after the radiograph was taken. Amendment 05 Oct 2019: 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). (s.a. Update von 08/2018)	—

Measure

Time frame

Measurement of the projected diameters of Mono-Marker Dual position maker Internal Marker Comparison of external markers regarding the agreement with internal marker (Gold-Standard) Note: Sample size is 100 (Standing) One arm, - 100 patients standing upright 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. Digital measurements are performed after the radiographs are taken by the investigator. The questionnaire should be answered immidiately after the radiograph was taken. Amendment 05 Oct 2019: 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). (s.a. Update von 08/2018)

—

Secondary

Measure	Time frame
Questionnaire regarding both markers after the radiograph. The questionnaire was specifically designed for the study. It asks about comfort of both marker types and direct comparison. Three questions.	—

Countries

Germany

Contacts

Public ContactChristoph Baltin

Klinik für Orthopädie & UnfallchirurgieUniversitätsklinikum Köln (AöR)

christoph.baltin@uk-koeln.de+49 221 478-7945

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026