M75.0 T84.9
Conditions
Interventions
Group 1: Baseline (day 14 to 1 before TAPE): MRI, clinical examination, questionnaires, blood sampling, biopsy if necessary.
TAPE (day 0)
Follow-up 6 weeks (clinical examination, questionnaires)
Fo
Sponsors
Klinikum der Universität München, Campus Großhadern
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Clinical indication for surgery or TAPE in subsequent refractory (> 3 months (*), > 6 months (**), > 12 months (***)) to conservative measures (drug therapy, physiotherapy, intra-articular steroid injections). Subgroups: AC (*), PJI (***), others (bursitis subacromialis/ subdeltoidea/ subscapularis (*), tendinitis of the long biceps tendon (*), epicondylitis humeri radialis/ ulnaris (*), painful osteoarthritis (**)), and age = 18 years as well as regular coagulation parameters (platelets > 50. 000/mm3 or 50 GPt/l, INR/PTT <1.5 times upper normal value) and kidney function normal for age (serum creatinine/GFR) as well as signed informed consent.
Exclusion criteria
Exclusion criteria: Lack of consent and/or lack of capacity to consent to the study as well as contraindications for the performance of a tissue biopsy, in particular severe blood coagulation disorder, renal insufficiency, allergies to local anesthetics, contraindications for MRI (only in the case of an MRI-guided biopsy) as well as previous arthroscopic or open surgical operations on the diseased joint (except in the case of the painful endoprosthesis) and, in the case of the endoprosthesis, mechanically associated pain, e.g. in the case of (aseptic component loosening or a material fracture) as well as systemic infection/sepsis. in case of (aseptic) component loosening or material fracture as well as systemic infection/ sepsis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain scale (VAS) and range of motion (ROM) at 12 months in patients with positive/negative local microbiome (C. acnes detection in tissue biopsy) in AC or change in pain scale (VAS) at 12 months in patients with positive/negative local microbiome (C. acnes detection in tissue biopsy) in PJI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable. | — |
Countries
Germany
Contacts
Public ContactSophia Goller
Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern
Outcome results
None listed