Can we improve the prophylactic profile of antibiotic treatment in shoulder prosthesis surgery? - A clinical microdialysis study assessing antibiotic concentrations in deadspace, bone, and soft tissue following weight-based cefuroxime dosage in both anatomic and reverse shoulder prosthesis surgery.

The RAS-study A reverse and anatomical prosthesis shoulder study Can we improve the prophylactic profile of antibiotic treatment in shoulder prosthesis surgery? - A clinical microdialysis study assessing antibiotic concentrations in deadspace, bone, and soft tissue following weight-based cefuroxime dosage in both anatomic and reverse shoulder prosthesis surgery. - RAS

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003078-36-DK

Enrollment

Registered

2020-07-13

Start date

2020-09-14

Completion date

Unknown

Last updated

2020-09-28

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

Conditions

Orthopedic infections MedDRA version: 21.0 Level: LLT Classification code 10021799 Term: Infection and inflammatory reaction due to other internal orthopedic device, implant, and graft System Organ Class: 100000004862

Interventions

Trade Name: Cefuroxime Pharmaceutical Form: Powder and solvent for concentrate for solution for infusion INN or Proposed INN: cefuroxime CAS Number: 55268-75-2 Other descriptive name: CEFUROXIME Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Signed informed consent. - Age minimum 18 years. - Elektiv RSA or ASA at the Department of Orthopedic Surgery, Aarhus University Hospital. - Normal kidney numbers prior to surgery(eGFR and kreatinin). - Fertile women have to use safe contraception prior to surgery, or a negative pregnancy-test on the day of surgery. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - Allergy towards cefuroxime. - Treatment with cefuroxime or meropeneme 4 days prior to the surgery.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this clinical cohort study is to determine local tissue concentrations of cefuroxime in deadspace, bone, muscle and subcutaneous tissue using micro dialysis in patients having either anatomic (ASA) or reverse (RSA) shoulder prosthesis surgery at Aarhus University Hospital. Approximate 30 min. prior to surgery, a weight-based dose of cefuroxime (20 mg / kg) is administered as a bolus infusion over 10 min intravenously. At the end of surgery micro dialysis catheters are placed in the deadspace, in the coracoid bone process, in the deltoid muscle and in subcutaneous tissue. The second cefuroxime dose is administered 8 hours after the first dose. Deadspace: At RSA, one catheter is placed in the large deadspace above the joint. At ASA, one catheter is placed in the prosthetic joint (intra-articular) and one above the rotator cuff (subacromial). In total, 4 catheters per patient in group 1 (RSA), and 5 catheters per patient in group 2 (ASA). ;Secondary Objective: - To use the pharmacokinetic results to evaluate current guidelines for perioperative dosing of cefuroxime. - To investigate local ischemic markers (lactate, glycerol, pyruvate and glucose) and inflammation-specific proteins in the examined compartments.;Primary end point(s): The Primary End Point is the time for which the cefuroxime concentration is maintained above the minimal inhibitory concentration, T>MIC, measured during the two dosing intervals in plasma, deadspace, bone, muscle and subcutaneous tissue;Timepoint(s) of evaluation of this end point: End Points will be evaluated at the end of the study.	—

Measure

Time frame

Main Objective: The main objective of this clinical cohort study is to determine local tissue concentrations of cefuroxime in deadspace, bone, muscle and subcutaneous tissue using micro dialysis in patients having either anatomic (ASA) or reverse (RSA) shoulder prosthesis surgery at Aarhus University Hospital. Approximate 30 min. prior to surgery, a weight-based dose of cefuroxime (20 mg / kg) is administered as a bolus infusion over 10 min intravenously. At the end of surgery micro dialysis catheters are placed in the deadspace, in the coracoid bone process, in the deltoid muscle and in subcutaneous tissue. The second cefuroxime dose is administered 8 hours after the first dose. Deadspace: At RSA, one catheter is placed in the large deadspace above the joint. At ASA, one catheter is placed in the prosthetic joint (intra-articular) and one above the rotator cuff (subacromial). In total, 4 catheters per patient in group 1 (RSA), and 5 catheters per patient in group 2 (ASA). ;Secondary Objective: - To use the pharmacokinetic results to evaluate current guidelines for perioperative dosing of cefuroxime. - To investigate local ischemic markers (lactate, glycerol, pyruvate and glucose) and inflammation-specific proteins in the examined compartments.;Primary end point(s): The Primary End Point is the time for which the cefuroxime concentration is maintained above the minimal inhibitory concentration, T>MIC, measured during the two dosing intervals in plasma, deadspace, bone, muscle and subcutaneous tissue;Timepoint(s) of evaluation of this end point: End Points will be evaluated at the end of the study.

—

Secondary

Measure	Time frame
Secondary end point(s): - Standard pharmacokinetic parametres in plasma, deadspace, bone, muscle and subcutaneous tissue. - Ischemic markers: lactate, glycerol, pyruvate and glucose in muscle, bone and subcutaneous tissue. - Specific proteins of inflammation.;Timepoint(s) of evaluation of this end point: End Points will be evaluated at the end of the study.	—

Countries

Denmark

Contacts

Public ContactSara Kousgaard Tøstesen

Aarhus University Hospital

201510204@post.au.dk004542202469

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026