Abbreviated Protocol for Two-Stage Exchange | NCT04662632

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	Local antibiotic irrigation via the VT-X7 (Vancomycin and Tobramycin Exchanged over 7 Days) Treatment System adjuvant to two-stage exchange arthroplasty per standard of care.	Combination Product: VT-X7 Treatment System with Tobramycin Sulfate Procedure: Two-stage exchange arthroplasty Combination Product: VT-X7 Treatment System with Vancomycin Hydrochloride
Control	Active Comparator	Standard of care for treatment of chronic PJI - two-stage exchange arthroplasty: surgical removal of the infected implant, aggressive debridement, and exchange arthroplasty with administration of adjuvant systemic antibiotics and temporary antibiotic-impregnated cement spacer.	Drug: Standard of Care Procedure: Two-stage exchange arthroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VT-X7 Treatment System with Tobramycin Sulfate	Combination Product	Seven-day local antibiotic irrigation with tobramycin sulfate via the VT-X7 Knee or Hip Spacer.	Experimental

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite Endpoint of Overall Success at 90 Days	Composite endpoint of Overall Success at 90 days consisting of: Stage 2 revision prosthesis implanted; Absence of PJI* post-Stage 2; Absence of reoperation*** of the affected joint pre- or post- Stage 2; and Absence of mortality. If clinical evidence of infection is present post-Stage 2 surgery, use the International Consensus Meeting on Musculoskeletal Infection 2018 guidelines for definitive PJI confirmation. Reoperation includes only procedures to irrigate, debride, and remove or replace the Stage 1 spacer or any Stage 2 implant component.	90 days

Secondary Outcomes

Measure	Description	Time Frame
Composite Endpoint of Overall Success at 180 Days	Composite endpoint of Overall Success at 180 days consisting of: Stage 2 revision prosthesis implanted; Absence of PJI* post-Stage 2; Absence of continued antibiotic therapy for treatment or prophylaxis of PJI ; Absence of reoperation* of the affected joint pre- and post-Stage 2; and Absence of mortality. If clinical evidence of infection is present post-Stage 2 surgery, use International Consensus Meeting on Musculoskeletal Infection 2018 guidelines for definitive PJI confirmation. Continued antibiotic therapy includes antibiotic therapy at 180 days or beyond 12 weeks post-Stage 2 surgery, excluding antibiotics for documented pre-procedural prophylaxis or infection other than PJI. Reoperation includes only procedures to irrigate, debride, remove or replace the Stage 1 spacer or any Stage 2 implant component.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Scheduled for two-stage exchange arthroplasty due to hip or knee PJI
Signed informed consent
22 to 84 years of age (inclusive)
Medical clearance for surgery
Preoperative diagnosis of PJI of the hip or knee per the International Consensus Meeting of Musculoskeletal Infection 2018 definition of Periprosthetic Hip and Knee Infection

Exclusion Criteria:

Patients with 2 or more prior one-stage or two-stage exchange arthroplasties of the infected joint;
Patients with acute PJI, defined as total joint arthroplasty surgery within 4 weeks prior to enrollment (Stage 1) in this study;
Patients with bacteremia or positive bacterial blood culture in the last 30 days;
Patients with concurrent PJI of more than one joint;
Patients with ongoing active infection of an intravenous site;
Patients who require long-term anticoagulation or antiplatelet therapy, and for whom bridging or withholding therapy is not recommended based on the individual's clinical condition;
Patients with advanced renal insufficiency (chronic kidney disease Stage 4 or greater or glomerular filtration rate <30 mL/min);
Patients on chemotherapy for malignant disease;
Patients on systemic glucocorticoid therapy (prednisone >10 mg/day or equivalent);
Patients with immunodeficiency (e.g., splenectomy, sickle cell anemia, Stage 3 human immunodeficiency virus infection, primary immunodeficiency disease, except immunodeficiency due to immunosuppressive therapy).
Patients who have an allergy to vancomycin hydrochloride or tobramycin sulfate (Note: prior history of red man syndrome is not considered an allergy);
Patients who have an allergy to titanium, titanium alloys, polymethylmethacrylate or polyurethane.
Patients who are pregnant or planning to become pregnant in the next 12 months;
Patients in whom negative pressure wound therapy is contraindicated;
Patients with a fungal PJI;
Patients who have a skeletal defect greater than 150 mm in length in the tibia or femur of the infected joint;
Patients who have a planned surgical procedure within 6 months of enrollment that can impact the conduct of the study;
Patients who are breastfeeding at the screening visit;
Patients who are incarcerated or are facing impending incarceration;
Patients who have been in treatment or referred for treatment for substance abuse within the past year;
Patients with any medical condition, including schizophrenia or another psychiatric disorder with hallucinations and/or delusions, that would interfere with the interpretation of the study results, the conduct of the study, or patient participation would not be in the best interest of the patient in the opinion of the Study Site Principal Investigator;
Patients who will participate in another clinical study of an investigational drug or investigational device or have participated in another clinical study of an investigational drug or investigational device within the past 30 days that would interfere with the interpretation of the study results or conduct of the study;
Patients who are judged by the Investigator to be unsuitable for the study.
Patients receiving immunosuppressive drug therapy for bone marrow or another transplant;
Patients currently or previously enrolled in this study;
Patients who receive therapy including any of the following biologic agents, which will not be withheld for a period beginning at least one dosing cycle (minimum 7 days) prior to Stage 1 surgery and ending at least 14 days following Stage 2 surgery:

Adalimumab (Humira) Tocilizumab (Actemra) Etanercept (Enbrel) Anakinra (Kineret) Golimumab (Simponi) Secukinumab (Cosentyx) Infliximab (Remicade) Ustekinumab (Stelara) Abatacept (Orencia) Rituximab (Rituxan) Certolizumab (Cimzia) Tofacitinib (Xeljanz) Belimumab (Benlysta)

Name	Affiliation	Role
Bryan Springer, MD	Ortho Carolina	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Arizona, Phoenix		Phoenix	Arizona	85004	United States
Harbor-UCLA Medical Center

PubMed Identifier	Type	Citation	Retractions
38604274	Derived	Springer BD, Higuera-Rueda CA, de Beaubien BC, Warner KD, Glassman AH, Parvataneni HK, Piuzzi NS. Safety Profile of Seven-Day Intra-articular Antibiotic Irrigation for the Treatment of Chronic Periprosthetic Joint Infection: A Prospective Randomized Phase II Comparative Study. J Arthroplasty. 2024 Sep;39(9 Suppl 1):S229-S235.e1. doi: 10.1016/j.arth.2024.03.069. Epub 2024 Apr 9.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	VT-X7	Local antibiotic irrigation via VT-X7 Treatment (Vancomycin and Tobramycin Exchanged over 7 Days) adjuvant to two-stage exchange arthroplasty per standard of care. VT-X7 Treatment with Tobramycin Sulfate: Seven-day local antibiotic irrigation with tobramycin sulfate via the VT-X7 Knee or Hip Spacer. VT-X7 Treatment with Vancomycin Hydrochloride: Seven-day local antibiotic irrigation with vancomycin hydrochloride via the VT-X7 Knee or Hip Spacer. Two-stage exchange arthroplasty: Stage 1 consists of surgical removal of the infected prosthesis, debridement, and implantation of a temporary spacer. Stage 2 surgery consists of explantation of the temporary spacer, debridement, and implantation of a permanent prosthesis, followed by systemic administration of postoperative antibiotics for 42 days (inclusive) to 90 days (inclusive).

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_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 17, 2022

Arm/Group Information

ID	Title	Description
BG000	VT-X7	Local antibiotic irrigation via the VT-X7 (Vancomycin and Tobramycin Exchanged over 7 Days) Treatment System adjuvant to two-stage exchange arthroplasty per standard of care. VT-X7 Treatment System with Tobramycin Sulfate: Seven-day local antibiotic irrigation with tobramycin sulfate via the VT-X7 Knee or Hip Spacer. Two-stage exchange arthroplasty: Stage 1 consists of surgical removal of the infected prosthesis, debridement, and implantation of a temporary spacer. Stage 2 surgery consists of explantation of the temporary spacer, debridement, and implantation of a permanent prosthesis, followed by systemic administration of postoperative antibiotics for 42 days (inclusive) to 90 days (inclusive). VT-X7 Treatment System with Vancomycin Hydrochloride: Seven-day local antibiotic irrigation with vancomycin hydrochloride via the VT-X7 Knee or Hip Spacer.
BG001	Standard of Care	Standard of care for treatment of chronic PJI - two-stage exchange arthroplasty: surgical removal of the infected implant, aggressive debridement, and exchange arthroplasty with administration of adjuvant systemic antibiotics and temporary antibiotic-impregnated cement spacer. Standard of Care: Forty-two days (minimum) systemic antibiotic administration adjuvant to two-stage exchange arthroplasty with temporary antibiotic-impregnated cement spacer per standard of care. Antibiotics will be selected by treatment provider and administered in accordance with national and local treatment guidelines. Two-stage exchange arthroplasty: Stage 1 consists of surgical removal of the infected prosthesis, debridement, and implantation of a temporary spacer. Stage 2 surgery consists of explantation of the temporary spacer, debridement, and implantation of a permanent prosthesis, followed by systemic administration of postoperative antibiotics for 42 days (inclusive) to 90 days (inclusive).
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00037 BG00139 BG00276

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

Composite Endpoint of Overall Success at 90 Days

Composite endpoint of Overall Success at 90 days consisting of:

Stage 2 revision prosthesis implanted;
Absence of PJI* post-Stage 2;
Absence of reoperation*** of the affected joint pre- or post- Stage 2; and
Absence of mortality.
- If clinical evidence of infection is present post-Stage 2 surgery, use the International Consensus Meeting on Musculoskeletal Infection 2018 guidelines for definitive PJI confirmation.
  - Reoperation includes only procedures to irrigate, debride, and remove or replace the Stage 1 spacer or any Stage 2 implant component.

Posted

Count of Participants

Participants

90 days

ID	Title	Description
OG000	VT-X7	Local antibiotic irrigation via VT-X7 Treatment (Vancomycin and Tobramycin Exchanged over 7 Days) adjuvant to two-stage exchange arthroplasty per standard of care. VT-X7 Treatment with Tobramycin Sulfate: Seven-day local antibiotic irrigation with tobramycin sulfate via the VT-X7 Knee or Hip Spacer. VT-X7 Treatment with Vancomycin Hydrochloride: Seven-day local antibiotic irrigation with vancomycin hydrochloride via the VT-X7 Knee or Hip Spacer. Two-stage exchange arthroplasty: Stage 1 consists of surgical removal of the infected prosthesis, debridement, and implantation of a temporary spacer. Stage 2 surgery consists of explantation of the temporary spacer, debridement, and implantation of a permanent prosthesis, followed by systemic administration of postoperative antibiotics for 42 days (inclusive) to 90 days (inclusive).
OG001	Standard of Care	Standard of care for treatment of chronic PJI - two-stage exchange arthroplasty: surgical removal of the infected implant, aggressive debridement, and exchange arthroplasty with administration of adjuvant systemic antibiotics and temporary antibiotic-impregnated cement spacer. Standard of Care: Forty-two days (minimum) systemic antibiotic administration adjuvant to two-stage exchange arthroplasty with temporary antibiotic-impregnated cement spacer per standard of care. Antibiotics will be selected by treatment provider and administered in accordance with national and local treatment guidelines. Two-stage exchange arthroplasty: Stage 1 consists of surgical removal of the infected prosthesis, debridement, and implantation of a temporary spacer. Stage 2 surgery consists of explantation of the temporary spacer, debridement, and implantation of a permanent prosthesis, followed by systemic administration of postoperative antibiotics for 42 days (inclusive) to 90 days (inclusive).

Units	Counts
Participants	OG00037 OG00139

Title

Denominators

Categories

Title	Measurements
	OG00033 OG00111

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		two-sided z-test for proportions		<0.0001														Superiority

Secondary

Composite Endpoint of Overall Success at 180 Days

Composite endpoint of Overall Success at 180 days consisting of:

Stage 2 revision prosthesis implanted;
Absence of PJI* post-Stage 2;
Absence of continued antibiotic therapy for treatment or prophylaxis of PJI **;
Absence of reoperation*** of the affected joint pre- and post-Stage 2; and
Absence of mortality.
- If clinical evidence of infection is present post-Stage 2 surgery, use International Consensus Meeting on Musculoskeletal Infection 2018 guidelines for definitive PJI confirmation.
  - Continued antibiotic therapy includes antibiotic therapy at 180 days or beyond 12 weeks post-Stage 2 surgery, excluding antibiotics for documented pre-procedural prophylaxis or infection other than PJI.
    - Reoperation includes only procedures to irrigate, debride, remove or replace the Stage 1 spacer or any Stage 2 implant component.

Posted

Count of Participants

Participants

180 days

ID	Title	Description
OG000	VT-X7	Local antibiotic irrigation via VT-X7 Treatment (Vancomycin and Tobramycin Exchanged over 7 Days) adjuvant to two-stage exchange arthroplasty per standard of care. VT-X7 Treatment with Tobramycin Sulfate: Seven-day local antibiotic irrigation with tobramycin sulfate via the VT-X7 Knee or Hip Spacer. VT-X7 Treatment with Vancomycin Hydrochloride: Seven-day local antibiotic irrigation with vancomycin hydrochloride via the VT-X7 Knee or Hip Spacer. Two-stage exchange arthroplasty: Stage 1 consists of surgical removal of the infected prosthesis, debridement, and implantation of a temporary spacer. Stage 2 surgery consists of explantation of the temporary spacer, debridement, and implantation of a permanent prosthesis, followed by systemic administration of postoperative antibiotics for 42 days (inclusive) to 90 days (inclusive).

Secondary

Composite Endpoint of Overall Success at 365 Days Consisting of:

Composite endpoint of Overall Success at 365 days consisting of:

Stage 2 revision prosthesis implanted;
Absence of PJI* post-Stage 2;
Absence of continued antibiotic therapy for treatment or prophylaxis of PJI **;
Absence of reoperation*** of the affected joint pre- and post-Stage 2; and
Absence of mortality.
- If clinical evidence of infection is present post-Stage 2 surgery, use International Consensus Meeting on Musculoskeletal Infection 2018 guidelines for definitive PJI confirmation.
  - Continued antibiotic therapy includes antibiotic therapy at 365 days or beyond 12 weeks post-Stage 2 surgery, excluding antibiotics for documented pre-procedural prophylaxis or infection other than PJI.
    - Reoperation includes only procedures to irrigate, debride, remove or replace the Stage 1 spacer or any Stage 2 implant component.

Posted

Count of Participants

Participants

365 days

ID	Title	Description
OG000	VT-X7	Local antibiotic irrigation via VT-X7 Treatment (Vancomycin and Tobramycin Exchanged over 7 Days) adjuvant to two-stage exchange arthroplasty per standard of care. VT-X7 Treatment with Tobramycin Sulfate: Seven-day local antibiotic irrigation with tobramycin sulfate via the VT-X7 Knee or Hip Spacer. VT-X7 Treatment with Vancomycin Hydrochloride: Seven-day local antibiotic irrigation with vancomycin hydrochloride via the VT-X7 Knee or Hip Spacer. Two-stage exchange arthroplasty: Stage 1 consists of surgical removal of the infected prosthesis, debridement, and implantation of a temporary spacer. Stage 2 surgery consists of explantation of the temporary spacer, debridement, and implantation of a permanent prosthesis, followed by systemic administration of postoperative antibiotics for 42 days (inclusive) to 90 days (inclusive).

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	VT-X7	Local antibiotic irrigation via the VT-X7 (Vancomycin and Tobramycin Exchanged over 7 Days) Treatment System adjuvant to two-stage exchange arthroplasty per standard of care. VT-X7 Treatment System with Tobramycin Sulfate: Seven-day local antibiotic irrigation with tobramycin sulfate via the VT-X7 Knee or Hip Spacer. Two-stage exchange arthroplasty: Stage 1 consists of surgical removal of the infected prosthesis, debridement, and implantation of a temporary spacer. Stage 2 surgery consists of explantation of the temporary spacer, debridement, and implantation of a permanent prosthesis, followed by systemic administration of postoperative antibiotics for 42 days (inclusive) to 90 days (inclusive). VT-X7 Treatment System with Vancomycin Hydrochloride: Seven-day local antibiotic irrigation with vancomycin hydrochloride via the VT-X7 Knee or Hip Spacer.	2	36	18	36	36	36
EG001	Standard of Care	Standard of care for treatment of chronic PJI - two-stage exchange arthroplasty: surgical removal of the infected implant, aggressive debridement, and exchange arthroplasty with administration of adjuvant systemic antibiotics and temporary antibiotic-impregnated cement spacer. Standard of Care: Forty-two days (minimum) systemic antibiotic administration adjuvant to two-stage exchange arthroplasty with temporary antibiotic-impregnated cement spacer per standard of care. Antibiotics will be selected by treatment provider and administered in accordance with national and local treatment guidelines. Two-stage exchange arthroplasty: Stage 1 consists of surgical removal of the infected prosthesis, debridement, and implantation of a temporary spacer. Stage 2 surgery consists of explantation of the temporary spacer, debridement, and implantation of a permanent prosthesis, followed by systemic administration of postoperative antibiotics for 42 days (inclusive) to 90 days (inclusive).	4	40	21	40	40	40

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Wound dehiscence/haemorrhage/erosion	Injury, poisoning and procedural complications	Systematic Assessment	EG0003 events3 affected36 at risk EG0013 events2 affected40 at risk
Joint dislocation/fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected36 at risk EG0013 events3 affected40 at risk
Musculoskeletal foreign body	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected40 at risk
Post-operative haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected40 at risk
Post-operative anaemia	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected40 at risk
Non-study drug toxicity	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected40 at risk
Device-related infection	Infections and infestations	Systematic Assessment	EG0004 events4 affected36 at risk EG0013 events3 affected40 at risk
Diverticulitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected40 at risk
Soft tissue infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected40 at risk
Bacterial sepsis	Infections and infestations	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected40 at risk
Clostridium difficile infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected40 at risk
Device dislocation	Product Issues	Systematic Assessment	EG0001 events1 affected36 at risk EG0018 events4 affected40 at risk
Device occlusion	Product Issues	Systematic Assessment	EG0002 events2 affected36 at risk EG0010 events0 affected40 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected36 at risk EG0011 events1 affected40 at risk
Joint instability	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected40 at risk
Facet joint syndrome	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected40 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected36 at risk EG0011 events1 affected40 at risk
Deep vein thrombosis	Vascular disorders	Systematic Assessment	EG0001 events1 affected36 at risk EG0011 events1 affected40 at risk
Haematoma	Vascular disorders	Systematic Assessment	EG0000 events0 affected36 at risk EG0012 events2 affected40 at risk
Shock	Vascular disorders	Systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected40 at risk
Pulmonary embolism/oedema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected36 at risk EG0012 events2 affected40 at risk
Respiratory failure/distress	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected36 at risk EG0011 events1 affected40 at risk
Congestive cardiac failure	Cardiac disorders	Systematic Assessment	EG0002 events2 affected36 at risk EG0011 events1 affected40 at risk
Cardiac arrest	Cardiac disorders	Systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected40 at risk
Blood loss anemia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected40 at risk
Aplasia pure red cell	Blood and lymphatic system disorders	Systematic Assessment	EG0003 events1 affected36 at risk EG0010 events0 affected40 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected40 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected40 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected40 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected40 at risk
Acute kidney injury	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected40 at risk
Nephropathy toxic	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected40 at risk
Toxic encedphalopathy	Nervous system disorders	Systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected40 at risk
Cerebrovascular accident	Nervous system disorders	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected40 at risk
Impaired wound healing	General disorders	Systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected40 at risk
Malnutrition	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected40 at risk
ST-T segment abnormal	Investigations	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected40 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected40 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Post-operative pain	Injury, poisoning and procedural complications	Systematic Assessment	EG00018 events15 affected36 at risk EG00125 events20 affected40 at risk
Post-operative anaemia	Injury, poisoning and procedural complications	Systematic Assessment	EG00020 events18 affected36 at risk EG00121 events15 affected40 at risk
Post-operative swelling	Injury, poisoning and procedural complications	Systematic Assessment	EG00014 events12 affected36 at risk EG00111 events10 affected40 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0009 events8 affected36 at risk EG00114 events11 affected40 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0003 events3 affected36 at risk EG0019 events8 affected40 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0008 events7 affected36 at risk EG0014 events4 affected40 at risk
Hypoaesthesia	Nervous system disorders	Systematic Assessment	EG0009 events6 affected36 at risk EG0014 events4 affected40 at risk
Joint noise (clicking, crepitus)	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00010 events5 affected36 at risk EG0018 events5 affected40 at risk
Urinary retention	Renal and urinary disorders	Systematic Assessment	EG0005 events5 affected36 at risk EG0014 events4 affected40 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0004 events3 affected36 at risk EG0015 events5 affected40 at risk
Anaemia/Blood loss anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG00011 events9 affected36 at risk EG0015 events5 affected40 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0006 events6 affected36 at risk EG0012 events1 affected40 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0003 events3 affected36 at risk EG0014 events4 affected40 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0003 events2 affected36 at risk EG0016 events4 affected40 at risk
COVID-19	Infections and infestations	Systematic Assessment	EG0003 events3 affected36 at risk EG0013 events3 affected40 at risk
Oedema peripheral	General disorders	Systematic Assessment	EG0003 events2 affected36 at risk EG0014 events4 affected40 at risk
Pruritis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 events2 affected36 at risk EG0014 events4 affected40 at risk
Dyspepsia/heartburn	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected36 at risk EG0014 events4 affected40 at risk
Haematocrit decreased	Investigations	Systematic Assessment	EG0001 events1 affected36 at risk EG0014 events4 affected40 at risk
Haemoglobin decreased	Investigations	Systematic Assessment	EG0001 events1 affected36 at risk EG0014 events4 affected40 at risk
Hyperkalemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected36 at risk EG0013 events3 affected40 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected36 at risk EG0017 events4 affected40 at risk
Paraesthesia	Nervous system disorders	Systematic Assessment	EG0006 events4 affected36 at risk EG0012 events1 affected40 at risk
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0003 events3 affected36 at risk EG0012 events2 affected40 at risk
Acute kidney injury	Renal and urinary disorders	Systematic Assessment	EG0004 events4 affected36 at risk EG0010 events0 affected40 at risk
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0003 events3 affected36 at risk EG0011 events1 affected40 at risk
Gait disturbance	General disorders	Systematic Assessment	EG0003 events3 affected36 at risk EG0011 events1 affected40 at risk
Hypokalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected36 at risk EG0012 events2 affected40 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0001 events1 affected36 at risk EG0013 events3 affected40 at risk
Joint Warmth	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected36 at risk EG0012 events2 affected40 at risk
Leukopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected36 at risk EG0013 events3 affected40 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected36 at risk EG0012 events2 affected40 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0002 events2 affected36 at risk EG0014 events3 affected40 at risk
PICC line occlusion	General disorders	Systematic Assessment	EG0001 events1 affected36 at risk EG0013 events3 affected40 at risk
White blood cell count increased	Investigations	Systematic Assessment	EG0001 events1 affected36 at risk EG0014 events3 affected40 at risk
Wound secretion	Injury, poisoning and procedural complications	Systematic Assessment	EG0005 events3 affected36 at risk EG0011 events1 affected40 at risk

ID	Term
D009328	Nebramycin
D007612	Kanamycin
D000617	Aminoglycosides
D006027	Glycosides
D002241	Carbohydrates
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation
D006020	Glycopeptides
D006001	Glycoconjugates
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins