Assessment of the extent of movement (ROM) after two-stage revision of a total knee prosthesis due to periprosthetic infection with a static versus mobile spacer: Controlled randomized study

Not Applicable

Recruiting

• Conditions: T84.7; Infection and inflammatory reaction due to other internal orthopaedic prosthetic devices, implants and grafts

• Registration Number: DRKS00014738
• Lead Sponsor: Orthopädische Klinik der Medizinischen Hochschule Hannover im Diakovere Annastift

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Infect-related knee arthroplasty removal with temporary spacer installation
-Age. 18-80 years
-Gender: Male, Female
-uncomplicated intraoperative course (e.g. no massive blood loss, no broken bones)

Exclusion Criteria

-BMI> 35
- known mental illness
- known disease of the cardiovascular system, which lead to restrictions in resilience
- known dementia
- known drug abuse
intraoperative or postoperative complications that restrict function or resilience (e.g. hemodynamically relevant bleeding, circulatory or respiratory complications)
-previous operative infection inspection with spacer implantation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of the ROM (Range of Motion) of> / = 10<br>Measurement takes place 1. before explantation of the total knee prosthesis, 2. after spacer installation, 3. day of admission before reimplantation of the total knee prosthesis, 4. discharge after reimplantation, 5. follow-up after 3 months

Secondary Outcome Measures

Name	Time	Method
Different functionality of the knee test or quality-of-life scores:<br>-VAS pain based on the visual pain scale<br>-Knee Society Score (KKS)<br>-WOMAC<br>-SF36<br><br>Data is queried 1. before explantation of the total knee prosthesis, 2. day of admission before reimplantation of the total knee prosthesis, 3. follow-up after 3 months<br>The SF36 is collected in the spacer period (6-10 weeks) between explantation and reimplantation of the total knee prosthesis in the form of a patient diary.