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Clinical investigation of septic and aseptic Joint prostetic failure - percutaneus punch biopsy as a novel way of diagnosis confirmation

Clinical investigation of septic and aseptic Joint prostetic failure - percutaneus punch biopsy as a novel way of diagnosis confirmation - SHARP

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00022931
Enrollment
132
Registered
2020-08-21
Start date
2020-08-24
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

T84.5 T84.0 T84.8

Interventions

Group 1: Joint tap and aspiration of synovial fluid Group 2: Punch biopsy of a prostetic joint and extraction of 5-7 biopsies from the synovial membrane

Sponsors

Department für Bewegungschirurgie - Vivantes Humboldt-Klinikum
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Preceding implantation of a shoulder, hip or knee endoprosthesis - Acute or chronic pain in the joint - Periprosthetic fracture - Instability of the endoprosthesis - Indications of wear / insufficiency of the enclosed plastic spacers - Indications of metal abrasion - Primary misalignment of the implant

Exclusion criteria

Exclusion criteria: - Confirmed periprosthetic infection - Proven allergy to fast-acting local anesthetics

Design outcomes

Primary

MeasureTime frame
Comparison of the respective examination results of the punch biopsies, the synovial fluid, pre-interventional blood analysis and the samples taken during the endoprosthesis replacement operation, in particular the sonicate of the prosthesis and the periprosthetic membrane (gold standard for infection diagnostics)

Secondary

MeasureTime frame
Analysis and comparison of the results of pathomorphological examinations of the punch biopsies and the samples taken during the replacement operation with regard to wear particles

Countries

Germany

Contacts

Public ContactRafal Jerzy Borucki

Klinik für Endoprothetik, Unfallchirurgie und Orthopädie, Vivantes Humboldt Klinikum

rafal.borucki@vivantes.de+4915129211687

Outcome results

None listed

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