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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00014738

Enrollment

Registered

2020-04-29

Start date

2019-04-08

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

T84.7

Interventions

Group 1: Patients in this group, whose knee endoprosthesis needs to be temporarily removed due to a periprosthetic infection, receive a static spacer for about 6-10 weeks. Group 2: Patients in this gr

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Improvement of the ROM (Range of Motion) of> / = 10 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

Measure	Time frame
Different functionality of the knee test or quality-of-life scores: -VAS pain based on the visual pain scale -Knee Society Score (KKS) -WOMAC -SF36 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 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.	—

Measure

Time frame

Different functionality of the knee test or quality-of-life scores: -VAS pain based on the visual pain scale -Knee Society Score (KKS) -WOMAC -SF36 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 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.

—

Countries

Germany

Contacts

Public ContactYvonne Noll

Orthopädische Klinik der Medizinischen Hochschule Hannover im Diakovere Annastift, Leitung Klinisches Studienmanagement

yvonne.noll@diakovere.de0511-5354-649

Outcome results

None listed

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