Trial document
This trial has been registered retrospectively.
DRKS00016927
Trial Description
Title
Two-stage Revision shoulder arthroplasty after deep infection of the shoulder: functional outcome, complications ans prognoses
Trial Acronym
[---]*
URL of the Trial
[---]*
Brief Summary in Lay Language
[---]*
Brief Summary in Scientific Language
The incidence of infections after primary shoulder arthroplasty is between 1 – 5% in literature, with even higher rates after reverse shoulder arthroplasty. The shoulder infection can be treated by surgical debridement with one stage or two stage exchange of the prosthesis or resection arthroplasty. The best outcomes for eradication of the infection has been reported by one or two stage revision and the resection arthroplasty. In this study we follow patients with deep infections of the shoulder after arthroplasties, rotator cuff surgery or fracture fixation that were treated with two stage revision arthroplasty. The patients have to be over 18 years old. One year after arthroplasty we check the functional outcome, complications like reinfection or dislocation and the general satisfaction of the patients.
Do you plan to share individual participant data with other researchers?
No
Description IPD sharing plan:
[---]*
Organizational Data
- DRKS00016927
- 2019/03/19
- [---]*
- yes
- Approved
- 2018-13493, Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
Secondary IDs
- [---]*
Health Condition or Problem studied
- T84.5 - Infection and inflammatory reaction due to internal joint prosthesis
- T84.6 - Infection and inflammatory reaction due to internal fixation device [any site]
- M00.91 - [generalization M00.9: Pyogenic arthritis, unspecified]
Interventions/Observational Groups
-
Patients, aged 18 or older, which had a deep infection of the shoulder and a two stage Revision shoulder arthroplasty
Follow-up one year after arthroplasty: clinical examination, anaysis of questionnaires and the patients health record
Characteristics
- Non-interventional
- Other
- Single arm study
- Open (masking not used)
- [---]*
- Uncontrolled/Single arm
- Prognosis
- Single (group)
- N/A
- N/A
Primary Outcome
- DASH (Disabilities of the arm, the shoulder and the Hand) score one year after arthroplasty
- Constant Shoulder Score one year after arthroplasty
Secondary Outcome
- Satisfaction of the patients one year after arthroplasty, acquisition by standardised questionnaire
- Reinfection- and dislocationrate one year after arthroplasty, acquisition by anamnesis and the patients health record
Countries of Recruitment
- Germany
Locations of Recruitment
- Medical Center
Recruitment
- Actual
- 2019/01/01
- 20
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
- Patients aged older than 18
- Deep infection of the shoulder after surgery
- two-stage revision shoulderarthroplasty
Exclusion Criteria
Patients younger than 18 years.
Addresses
-
start of 1:1-Block address primary-sponsor
- BG Klinik Ludwigshafen
- Ms. Sandra Hornung
- Ludwig-Guttmann-Str. 13
- 67071 Ludwigshafen
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- 0621.6810.8818
- [---]*
- sandra.hornung at bgu-ludwigshafen.de
- [---]*
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- BG Klinik Ludwigshafen
- Ms. Sandra Hornung
- Ludwig-Guttmann-Str. 13
- 67071 Ludwigshafen
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0621.6810.8818
- [---]*
- sandra.hornung at bgu-ludwigshafen.de
- [---]*
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- BG Klinik Ludwigshafen
- Ms. Sandra Hornung
- Ludwig-Guttmann-Str. 13
- 67071 Ludwigshafen
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 0621.6810.8818
- [---]*
- sandra.hornung at bgu-ludwigshafen.de
- [---]*
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- BG Klinik Ludwigshafen
- Ms. Sandra Hornung
- Ludwig-Guttmann-Str. 13
- 67071 Ludwigshafen
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- 0621.6810.8818
- [---]*
- sandra.hornung at bgu-ludwigshafen.de
- [---]*
end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up complete
- [---]*
- [---]*
- 2019/12/31
- 24
- 24
Trial Publications, Results and other Documents
- [---]*