Prospective randomized multicenter clinical observationan of a novel cement spacer implants for for knee implant-two stage exchange after septic implant loosening

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00004357

Enrollment

100

Registered

2012-09-12

Start date

2012-07-04

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

T84.5

Interventions

Group 1: control-arm: Patients are included with septic loosening of the primary knee implant and indications for knee-replacement and patients with a temporary spacer implantat consist of an long -te

Eligibility

Sex/Gender

All

Age

50 Years to 80 Years

Inclusion criteria

Inclusion criteria: • aged 50 to 80 years • diagnosis of septic loosening of knee prostheses with a primary indication for two-stage exchange • The ability to understand the scope and significance of the study and the willingness and the ability to take part in the following necessary follow-up examinations. • existence of a written consent form

Exclusion criteria

Exclusion criteria: • presence of a tumor disease • Known allergy to materials used • Participation in other studies • nursing and pregnant women and those women planning to become pregnant during the study period • non-availability for the duration of the study • Inadequate knowledge of German (questionnaires)

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is the infection control after one year postoperatively determined by the existence of a stable revision prosthesis without clinical, laboratory and radiological signs of persistent or re-infection. There are no reliable data for this specific clinical scenario, especially in the German-speaking countries, the study is hypothesis-created. Within the hip replacement standardized tissue samples are taken for the microbiology and pathology. The explanted prothesis is examined microbiologically. After a six-week interval a minimally-invasive sampling (biopsy) of peri-implant tissues is performed. The joint fluid and the tissue sample are examined microbiologically and the tissue sample is examined histologically. Within the spacer explantation standardized tissue samples are taken for the microbiology and pathology. The spacer is examined microbiologically. The quality of life are evaluated by questionnaires (WOMAC, EQ-5D, SF-36) before the intervention and after 3 and 12 months follow-up.	—

Measure

Time frame

The primary outcome measure is the infection control after one year postoperatively determined by the existence of a stable revision prosthesis without clinical, laboratory and radiological signs of persistent or re-infection. There are no reliable data for this specific clinical scenario, especially in the German-speaking countries, the study is hypothesis-created. Within the hip replacement standardized tissue samples are taken for the microbiology and pathology. The explanted prothesis is examined microbiologically. After a six-week interval a minimally-invasive sampling (biopsy) of peri-implant tissues is performed. The joint fluid and the tissue sample are examined microbiologically and the tissue sample is examined histologically. Within the spacer explantation standardized tissue samples are taken for the microbiology and pathology. The spacer is examined microbiologically. The quality of life are evaluated by questionnaires (WOMAC, EQ-5D, SF-36) before the intervention and after 3 and 12 months follow-up.

—

Secondary

Measure	Time frame
1.Time until the infection recurrence or treatment failure (calculated using Kaplan-Meier analysis, if needed, a multivariate Cox regression) at follow-up 2.Allocation of resources (material costs, hospitalization, number of necessary interventions) 3.Function (measured using the Western Ontario and McMaster Osteoarthritis Index (WOMAC score) and Harris Hip Score) and quality of life (using the EuroQol and SF-36 scores) at follow-up 4.Radiological signs of aseptic or septic loosening of the implant revision during follow-up	—

Measure

Time frame

1.Time until the infection recurrence or treatment failure (calculated using Kaplan-Meier analysis, if needed, a multivariate Cox regression) at follow-up 2.Allocation of resources (material costs, hospitalization, number of necessary interventions) 3.Function (measured using the Western Ontario and McMaster Osteoarthritis Index (WOMAC score) and Harris Hip Score) and quality of life (using the EuroQol and SF-36 scores) at follow-up 4.Radiological signs of aseptic or septic loosening of the implant revision during follow-up

—

Countries

Germany

Contacts

Public ContactSarah Zaatreh

Forschungslabor für Biomechanik und Implantattechnologie Orthopädische Klinik und Poliklinik, Universitätsmedizin Rostock

sarah.zaatreh@med.uni-rostock.de03814949374

Outcome results

None listed

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