Long-Term Retention of Gadolinium in Bone | NCT01853163

Status Module

Name	Class
Bayer	INDUSTRY
GE Healthcare	INDUSTRY
Guerbet	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
GBCA	Other	Patients who have received GBCAs in the past	Procedure: Gadolinium analysis in bone and tissue samples

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gadolinium analysis in bone and tissue samples	Procedure	Gadolinium analysis in bone and tissue samples from patients undergoing an orthopaedic surgical procedure who had received GBCAs in the past.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Concentration of Total Gadolinium in Trabecular Bone	Concentration of total Gd in trabecular bone determined by ICP-MS	Day 0 (visit 2, surgery); optional visit 6 (second surgery)
Concentration of Total Gadolinium in Cortical Bone	Concentration of total Gd in cortical bone determined by ICP-MS	Day 0 (visit 2, surgery); optional visit 6 (second surgery)

Secondary Outcomes

Measure	Description	Time Frame
Concentration of Total Gd in Skin Tissue Samples	Concentration of total Gd in skin tissue samples (determined by ICP-MS (inductively coupled plasma mass spectrometry)), collected at the time of the scheduled orthopaedic surgical procedure, from a biopsy from the edge of the surgical wound or the amputated part. Analysation of a single skin tissue sample; in case of a second surgery a further sample was taken.

Eligibility Module

Name	Affiliation	Role
Christoph Lohmann, Professor MD	University Hospital Magdeburg, Germany	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Cedar-Sinai Medical Center		Los Angeles	California	90048	United States
University Hospital Halle (Saale)

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	GBCA Exposure Group - Normal Renal Function.	Patients with normal renal function (eGFR > 60 ml/min /1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
FG001	GBCA Exposure Group - Impaired Renal Function.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 29, 2016	Jun 23, 2020

Arm/Group Information

ID	Title	Description
BG000	GBCA Exposure Group - Normal Renal Function.	Patients with normal renal function (eGFR > 60 ml/min /1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
BG001	GBCA Exposure Group - Impaired Renal Function.	Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
BG002	GBCA Naive - Control Group With Normal Renal Function.	GBCA naive patients with normal renal function (eGFR > 60 ml/min/1.73 m2)
BG003	GBCA Naive - Control Group With Impaired Renal Function.	GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG00045 ParticipantsBG00129 ParticipantsBG0027 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00045 ParticipantsBG00129 ParticipantsBG002

Race and Ethnicity Not Collected

Race and Ethnicity were not collected from any participant.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG0000 ParticipantsBG0010 ParticipantsBG002

Height

Mean

Standard Deviation

Title	Denominators	Categories
	ParticipantsBG00045 ParticipantsBG00129 ParticipantsBG002

Weight

Mean

Standard Deviation

Title	Denominators	Categories
	ParticipantsBG00045 ParticipantsBG00129 ParticipantsBG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Concentration of Total Gadolinium in Trabecular Bone

Concentration of total Gd in trabecular bone determined by ICP-MS

Note: Below values for both control groups (0 (0%)) are "NA = Descriptive statistics not performed since it does not satisfy 2/3 of GBCA concentration values are available and above BLQ", 2 patients of the control group with impaired renal function have values > BLQ, max 1.921 ug/g.

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms/gram

Day 0 (visit 2, surgery); optional visit 6 (second surgery)

ID	Title	Description
OG000	GBCA Exposure Group - Normal Renal Function	Patients with normal renal function (eGFR > 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG001	GBCA Exposure Group - Impaired Renal Function	Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG002	GBCA Naive - Control Group With Normal Renal Function	GBCA naive patients with normal renal function (eGFR > 60 ml/min/1.73 m2)
OG003	GBCA Naive - Control Group With Impaired Renal Function	GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)

Units	Counts
Participants	OG00045 OG00129 OG0027 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.335± 476.7 OG0010.783± 413.8 OG0020± 0 OG003

Primary

Concentration of Total Gadolinium in Cortical Bone

Concentration of total Gd in cortical bone determined by ICP-MS

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms/gram

Day 0 (visit 2, surgery); optional visit 6 (second surgery)

ID	Title	Description
OG000	GBCA Exposure Group - Normal Renal Function	Patients with normal renal function (eGFR > 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG001	GBCA Exposure Group - Impaired Renal Function	Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG002	GBCA Naive - Control Group With Normal Renal Function	GBCA naive patients with normal renal function (eGFR > 60 ml/min/1.73 m2)

Secondary

Concentration of Total Gd in Skin Tissue Samples

Concentration of total Gd in skin tissue samples (determined by ICP-MS (inductively coupled plasma mass spectrometry)), collected at the time of the scheduled orthopaedic surgical procedure, from a biopsy from the edge of the surgical wound or the amputated part. Analysation of a single skin tissue sample; in case of a second surgery a further sample was taken.

Note: Below values for all groups (0 (0%)) are "NA = Descriptive statistics not performed since it does not satisfy 2/3 of GBCA concentration values are available and above BLQ", 1 patient of the control group with impaired renal function has a value > BLQ, max 0.138 ug/g.

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms/gram

Day 0 (visit 2, surgery); optional visit 6 (second surgery)

ID	Title	Description
OG000	GBCA Exposure Group - Normal Renal Function	Patients with normal renal function (eGFR > 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG001	GBCA Exposure Group - Impaired Renal Function	Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG002

Secondary

Concentration of Calcium in Skin Tissue Samples

Concentration of calcium in skin tissue samples determined by ICP-MS

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms/gram

Day 0 (visit 2, surgery); optional visit 6 (second surgery)

ID	Title	Description
OG000	GBCA Exposure Group - Normal Renal Function	Patients with normal renal function (eGFR > 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG001	GBCA Exposure Group - Impaired Renal Function.	Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG002	GBCA Naive - Control Group With Normal Renal Function	GBCA naive patients with normal renal function (eGFR > 60 ml/min/1.73 m2)
OG003	GBCA Naive - Control Group With Impaired Renal Function	GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)

Secondary

Concentration of Calcium in Cortical Bone Tissue Samples

Concentration of calcium in cortical bone tissue samples determined by ICP-MS

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms/gram

Day 0 (visit 2, surgery); optional visit 6 (second surgery)

ID	Title	Description
OG000	GBCA Exposure Group - Normal Renal Function	Patients with normal renal function (eGFR > 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG001	GBCA Exposure Group - Impaired Renal Function.	Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG002	GBCA Naive - Control Group With Normal Renal Function	GBCA naive patients with normal renal function (eGFR > 60 ml/min/1.73 m2)
OG003	GBCA Naive - Control Group With Impaired Renal Function

Secondary

Concentrations of Phosphorus in Cortical Bone Tissue Samples

Concentrations of phosphorus in cortical bone tissue samples determined by ICP-MS

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms/gram

Day 0 (visit 2, surgery); optional visit 6 (second surgery)

ID	Title	Description
OG000	GBCA Exposure Group - Normal Renal Function.	Patients with normal renal function (eGFR > 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG001	GBCA Exposure Group - Impaired Renal Function.	Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG002	GBCA Naive - Control Group With Normal Renal Function	GBCA naive patients with normal renal function (eGFR > 60 ml/min/1.73 m2)
OG003	GBCA Naive - Control Group With Impaired Renal Function

Secondary

Concentrations of Sodium in Cortical Bone Tissue Samples

Concentrations of sodium in cortical bone tissue samples determined by ICP-MS

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms/gram

Day 0 (visit 2, surgery); optional visit 6 (second surgery)

ID	Title	Description
OG000	GBCA Exposure Group - Normal Renal Function.	Patients with normal renal function (eGFR > 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG001	GBCA Exposure Group - Impaired Renal Function	Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG002	GBCA Naive - Control Group With Normal Renal Function	GBCA naive patients with normal renal function (eGFR > 60 ml/min/1.73 m2)
OG003	GBCA Naive - Control Group With Impaired Renal Function

Secondary

Concentrations of Zinc in Bone Tissue Samples (Cortical)

Concentrations of zinc in cortical bone tissue samples determined by ICP-MS

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms/gram

Day 0 (visit 2, surgery); optional visit 6 (second surgery)

ID	Title	Description
OG000	GBCA Exposure Group - Normal Renal Function	Patients with normal renal function (eGFR > 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG001	GBCA Exposure Group - Impaired Renal Function	Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG002	GBCA Naive - Control Group With Normal Renal Function	GBCA naive patients with normal renal function (eGFR > 60 ml/min/1.73 m2)
OG003	GBCA Naive - Control Group With Impaired Renal Function	GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)

Secondary

Concentration of Potassium in Cortical Bone Tissue Samples

Concentration of potassium in bone (cortical) tissue samples determined by ICP-MS

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms/gram

Day 0 (visit 2, surgery); optional visit 6 (second surgery)

ID	Title	Description
OG000	GBCA Exposure Group - Normal Renal Function	Patients with normal renal function (eGFR > 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG001	GBCA Exposure Group - Impaired Renal Function	Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG002	GBCA Naive - Control Group With Normal Renal Function	GBCA naive patients with normal renal function (eGFR > 60 ml/min/1.73 m2)
OG003	GBCA Naive - Control Group With Impaired Renal Function

Secondary

Concentrations of Iron in Cortical Bone Tissue Samples

Concentrations of iron in bone (cortical) tissue samples determined by ICP-MS

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms/gram

Day 0 (visit 2, surgery); optional visit 6 (second surgery)

ID	Title	Description
OG000	GBCA Exposure Group - Normal Renal Function	Patients with normal renal function (eGFR > 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG001	GBCA Exposure Group - Impaired Renal Function	Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG002	GBCA Naive - Control Group With Normal Renal Function.	GBCA naive patients with normal renal function (eGFR > 60 ml/min/1.73 m2)
OG003	GBCA Naive - Control Group With Impaired Renal Function	GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)

Secondary

Concentration of Calcium in Trabecular Bone Tissue Samples

Concentrations of calcium in trabecular bone tissue samples determined by ICP-MS

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms/gram

Day 0 (visit 2, surgery); optional visit 6 (second surgery)

ID	Title	Description
OG000	GBCA Exposure Group - Normal Renal Function	Patients with normal renal function (eGFR > 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG001	GBCA Exposure Group - Impaired Renal Function	Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG002	GBCA Naive - Control Group With Normal Renal Function	GBCA naive patients with normal renal function (eGFR > 60 ml/min/1.73 m2)
OG003	GBCA Naive - Control Group With Impaired Renal Function

Secondary

Concentration of Phosphorus in Trabecular Bone Tissue Samples

Concentrations of phosphorus in bone (trabecular) tissue samples determined by ICP-MS

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms/gram

Day 0 (visit 2, surgery); optional visit 6 (second surgery)

ID	Title	Description
OG000	GBCA Exposure Group - Normal Renal Function.	Patients with normal renal function (eGFR > 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG001	GBCA Exposure Group - Impaired Renal Function	Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG002	GBCA Naive - Control Group With Normal Renal Function	GBCA naive patients with normal renal function (eGFR > 60 ml/min/1.73 m2)
OG003	GBCA Naive - Control Group With Impaired Renal Function

Secondary

Concentrations of Sodium in Trabecular Bone Tissue Samples

Concentrations of sodium in trabecular bone tissue samples determined by ICP-MS

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms/gram

Day 0 (visit 2, surgery); optional visit 6 (second surgery)

ID	Title	Description
OG000	GBCA Exposure Group - Normal Renal Function	Patients with normal renal function (eGFR > 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG001	GBCA Exposure Group - Impaired Renal Function	Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG002	GBCA Naive - Control Group With Normal Renal Function	GBCA naive patients with normal renal function (eGFR > 60 ml/min/1.73 m2)
OG003	GBCA Naive - Control Group With Impaired Renal Function

Secondary

Concentrations of Zinc in Trabecular Bone Tissue Samples

Concentrations of zinc in trabecular bone tissue samples determined by ICP-MS

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms/gram

Day 0 (visit 2, surgery); optional visit 6 (second surgery)

ID	Title	Description
OG000	GBCA Exposure Group - Normal Renal Function	Patients with normal renal function (eGFR > 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG001	GBCA Exposure Group - Impaired Renal Function	Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG002	GBCA Naive - Control Group With Normal Renal Function	GBCA naive patients with normal renal function (eGFR > 60 ml/min/1.73 m2)
OG003	GBCA Naive - Control Group With Impaired Renal Function

Secondary

Concentrations of Potassium in Trabecular Bone Tissue Samples

Concentrations of potassium in trabecular bone tissue samples determined by ICP-MS

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms/gram

Day 0 (visit 2, surgery); optional visit 6 (second surgery)

ID	Title	Description
OG000	GBCA Exposure Group - Normal Renal Function	Patients with normal renal function (eGFR > 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG001	GBCA Exposure Group - Impaired Renal Function	Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG002	GBCA Naive - Control Group With Normal Renal Function	GBCA naive patients with normal renal function (eGFR > 60 ml/min/1.73 m2)
OG003	GBCA Naive - Control Group With Impaired Renal Function

Secondary

Concentrations of Iron in Trabecular Bone Tissue Samples

Concentrations of iron in trabecular bone tissue samples determined by ICP-MS

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms/gram

Day 0 (visit 2, surgery); optional visit 6 (second surgery)

ID	Title	Description
OG000	GBCA Exposure Group - Normal Renal Function	Patients with normal renal function (eGFR > 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG001	GBCA Exposure Group - Impaired Renal Function	Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG002	GBCA Naive - Control Group With Normal Renal Function	GBCA naive patients with normal renal function (eGFR > 60 ml/min/1.73 m2)
OG003	GBCA Naive - Control Group With Impaired Renal Function

Secondary

Concentrations of Phosphorus in Skin Tissue Samples

Concentrations of phosphorus in skin tissue samples determined by ICP-MS

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms/gram

Day 0 (visit 2, surgery); optional visit 6 (second surgery)

ID	Title	Description
OG000	GBCA Exposure Group - Normal Renal Function	Patients with normal renal function (eGFR > 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG001	GBCA Exposure Group - Impaired Renal Function	Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG002	GBCA Naive - Control Group With Normal Renal Function	GBCA naive patients with normal renal function (eGFR > 60 ml/min/1.73 m2)
OG003	GBCA Naive - Control Group With Impaired Renal Function	GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)

Secondary

Concentrations of Sodium in Skin Tissue Samples

Concentrations of sodium in skin tissue samples determined by ICP-MS

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms/gram

Day 0 (visit 2, surgery); optional visit 6 (second surgery)

ID	Title	Description
OG000	GBCA Exposure Group - Normal Renal Function	Patients with normal renal function (eGFR > 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG001	GBCA Exposure Group - Impaired Renal Function	Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG002	GBCA Naive - Control Group With Normal Renal Function	GBCA naive patients with normal renal function (eGFR > 60 ml/min/1.73 m2)
OG003	GBCA Naive - Control Group With Impaired Renal Function	GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)

Secondary

Concentrations of Zinc in Skin Tissue Samples

Concentrations of zinc in skin tissue samples determined by ICP-MS

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms/gram

Day 0 (visit 2, surgery); optional visit 6 (second surgery)

ID	Title	Description
OG000	GBCA Exposure Group - Normal Renal Function	Patients with normal renal function (eGFR > 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG001	GBCA Exposure Group - Impaired Renal Function	Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG002	GBCA Naive - Control Group With Normal Renal Function	GBCA naive patients with normal renal function (eGFR > 60 ml/min/1.73 m2)
OG003	GBCA Naive - Control Group With Impaired Renal Function	GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)

Secondary

Concentration of Potassium in Skin Tissue Samples

Concentration of potassium in skin tissue samples determined by ICP-MS

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms/gram

Day 0 (visit 2, surgery); optional visit 6 (second surgery)

ID	Title	Description
OG000	GBCA Exposure Group - Normal Renal Function	Patients with normal renal function (eGFR > 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG001	GBCA Exposure Group - Impaired Renal Function	Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG002	GBCA Naive - Control Group With Normal Renal Function	GBCA naive patients with normal renal function (eGFR > 60 ml/min/1.73 m2)
OG003	GBCA Naive - Control Group With Impaired Renal Function	GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)

Secondary

Concentration of Iron in Skin Tissue Samples

Concentration of iron in skin tissue samples determined by ICP-MS

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms/gram

Day 0 (visit 2, surgery); optional visit 6 (second surgery)

ID	Title	Description
OG000	GBCA Exposure Group - Normal Renal Function	Patients with normal renal function (eGFR > 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG001	GBCA Exposure Group - Impaired Renal Function	Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
OG002	GBCA Naive - Control Group With Normal Renal Function	GBCA naive patients with normal renal function (eGFR > 60 ml/min/1.73 m2)
OG003	GBCA Naive - Control Group With Impaired Renal Function	GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Cardiac Failure Congestive	Cardiac disorders	MedDRA (17.1)	Systematic Assessment		EG0001 events1 affected74 at risk EG0010 events0 affected18 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA (17.1)	Systematic Assessment		EG0001 events1 affected74 at risk EG0010 events0 affected18 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Systematic Assessment		EG0001 events1 affected74 at risk EG0010 events0 affected18 at risk
Nephrogenic Systemic Fibrosis	Skin and subcutaneous tissue disorders	MedDRA (17.1)	Systematic Assessment	In one subject skin biopsy was assessed as "suspicious for NSF". However, there was no clinical evidence for NSF.	EG0000 events0 affected74 at risk EG0010 events0 affected18 at risk
Pneumonia	Infections and infestations	MedDRA (17.1)	Systematic Assessment		EG0000 events0 affected74 at risk EG0011 events1 affected18 at risk
Delirium	Psychiatric disorders	MedDRA (17.1)	Systematic Assessment		EG0000 events0 affected74 at risk EG0011 events1 affected18 at risk
Renal Failure	Renal and urinary disorders	MedDRA (17.1)	Systematic Assessment		EG0000 events0 affected74 at risk EG0011 events1 affected18 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac disorder	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0002 events1 affected74 at risk EG0011 events1 affected18 at risk
Gastrointestinal Disorders	Gastrointestinal disorders	MedDRA (17.1)	Systematic Assessment	EG00015 events13 affected74 at risk EG0012 events2 affected18 at risk
General Disorders And Administration	General disorders	MedDRA (17.1)	Systematic Assessment	EG00010 events8 affected74 at risk EG0011 events1 affected18 at risk
Infections And Infestations	Infections and infestations	MedDRA (17.1)	Systematic Assessment	EG0006 events5 affected74 at risk EG0012 events2 affected18 at risk
Injury, Poisoning And Procedural Complications	Injury, poisoning and procedural complications	MedDRA (17.1)	Systematic Assessment	EG00013 events12 affected74 at risk EG0014 events4 affected18 at risk
Investigations	Investigations	MedDRA (17.1)	Systematic Assessment	EG00020 events5 affected74 at risk EG0010 events0 affected18 at risk
Metabolism And Nutrition Disorders	Metabolism and nutrition disorders	MedDRA (17.1)	Systematic Assessment	EG0005 events4 affected74 at risk EG0010 events0 affected18 at risk
Musculoskeletal And Connective Tissue Disorders	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Systematic Assessment	EG00010 events9 affected74 at risk EG0010 events0 affected18 at risk
Nervous System Disorders	Nervous system disorders	MedDRA (17.1)	Systematic Assessment	EG0002 events2 affected74 at risk EG0011 events1 affected18 at risk
Psychiatric Disorders	Psychiatric disorders	MedDRA (17.1)	Systematic Assessment	EG00012 events11 affected74 at risk EG0013 events3 affected18 at risk
Renal And Urinary Disorders	Renal and urinary disorders	MedDRA (17.1)	Systematic Assessment	EG0002 events2 affected74 at risk EG0012 events2 affected18 at risk
Respiratory, Thoracic And Mediastinal Disorders	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Systematic Assessment	EG0003 events2 affected74 at risk EG0010 events0 affected18 at risk
Skin And Subcutaneous Tissue Disorders	Skin and subcutaneous tissue disorders	MedDRA (17.1)	Systematic Assessment	EG0005 events5 affected74 at risk EG0011 events1 affected18 at risk
Vascular Disorders	Vascular disorders	MedDRA (17.1)	Systematic Assessment	EG00014 events10 affected74 at risk EG0012 events2 affected18 at risk
Blood And Lymphatic System Disorders	Blood and lymphatic system disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected74 at risk EG0013 events2 affected18 at risk

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	GBCA Exposure Group	Patients who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.	2	74	3	74	35	74
EG001	GBCA Naive Control Group	GBCA naive patients	0	18	2	18	10	18