Trial document

PLEASE NOTE:
This trial has been registered retrospectively.

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DRKS-ID: DRKS00016927

Trial Description

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Title

Two-stage Revision shoulder arthroplasty after deep infection of the shoulder: functional outcome, complications ans prognoses

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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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.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

DRKS-ID: DRKS00016927
Date of Registration in DRKS: 2019/03/19
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 2018-13493, Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz

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Secondary IDs

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Health Condition or Problem studied

ICD10: T84.5 - Infection and inflammatory reaction due to internal joint prosthesis
ICD10: T84.6 - Infection and inflammatory reaction due to internal fixation device [any site]
ICD10: M00.91 - [generalization M00.9: Pyogenic arthritis, unspecified]

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Interventions/Observational Groups

Arm 1: 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

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Characteristics

Study Type: Non-interventional
Study Type Non-Interventional: Other
Allocation: Single arm study
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Uncontrolled/Single arm
Purpose: Prognosis
Assignment: Single (group)
Phase: N/A
Off-label Drug use: N/A

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Primary Outcome

- DASH (Disabilities of the arm, the shoulder and the Hand) score one year after arthroplasty
- Constant Shoulder Score one year after arthroplasty

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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

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Countries of Recruitment

DE: Germany

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Locations of Recruitment

Medical Center BG Klinik Ludwigshafen, Ludwigshafen am Rhein

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2019/01/01
Target Sample Size: 20
Monocenter/Multicenter trial: Monocenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: no maximum age

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Additional Inclusion Criteria

- Patients aged older than 18
- Deep infection of the shoulder after surgery
- two-stage revision shoulderarthroplasty

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Exclusion Criteria

Patients younger than 18 years.

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Addresses

Primary Sponsor
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- BG Klinik Ludwigshafen
- Ms. Sandra Hornung
- Ludwig-Guttmann-Str. 13
- 67071 Ludwigshafen
- Germany
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- Telephone: 0621.6810.8818
- Fax: [---]*
- E-mail: sandra.hornung at bgu-ludwigshafen.de
- URL: [---]*
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Contact for Scientific Queries
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- BG Klinik Ludwigshafen
- Ms. Sandra Hornung
- Ludwig-Guttmann-Str. 13
- 67071 Ludwigshafen
- Germany
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- Telephone: 0621.6810.8818
- Fax: [---]*
- E-mail: sandra.hornung at bgu-ludwigshafen.de
- URL: [---]*
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Contact for Public Queries
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- BG Klinik Ludwigshafen
- Ms. Sandra Hornung
- Ludwig-Guttmann-Str. 13
- 67071 Ludwigshafen
- Germany
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- Telephone: 0621.6810.8818
- Fax: [---]*
- E-mail: sandra.hornung at bgu-ludwigshafen.de
- URL: [---]*
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Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)
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- BG Klinik Ludwigshafen
- Ms. Sandra Hornung
- Ludwig-Guttmann-Str. 13
- 67071 Ludwigshafen
- Germany
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- Telephone: 0621.6810.8818
- Fax: [---]*
- E-mail: sandra.hornung at bgu-ludwigshafen.de
- URL: [---]*
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Status

Recruitment Status: Recruiting complete, follow-up complete
Reason, if "Recruitment stopped after recruiting started" or "Recruiting withdrawn before recruting started": [---]*
Reason, if Reason for Recruiting Stop "Other": [---]*
Study Closing (LPLV): 2019/12/31
Number of Participants in Germany after Recruiting complete: 24
Total Number of Participants (all Sites worldwide) after Recruiting complete: 24

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Trial Publications, Results and other Documents

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