Status:
COMPLETED
PMCF Study to Evaluate Safety of TIPMED TPM08 Total Knee Prosthesis Systems and TPM Revision Knee Prosthesis Systems
Lead Sponsor:
TIPMED Medical Device Manufacturing Ltd. Co.
Conditions:
Knee Arthroplasty
Eligibility:
All Genders
18+ years
Brief Summary
This is a observational multicenter study to assess the safety of TIPMED TPM08 Total Knee Prosthesis Systems and TPM Revision Knee Prosthesis Systems used for total knee arthroplasty or revision knee ...
Detailed Description
In this study, short term (12 months) safety data of TIPMED TPM08 Total Knee Prosthesis System and TPM Revision Knee Prosthesis System will be evaluated using Case Report Forms (CRF). A CRF should be ...
Eligibility Criteria
Inclusion
- Male and female subjects aged older than 18 years of age,
- The subjects with appropriate indication for primary total or revision knee arthroplasty,
- The subjects who used TIPMED TPM08 Primary Total or Revision Knee Prosthesis System in their surgery,
- Subjects not under legal disability,
- Subjects or guardian who is willing and able to sign the informed consent form.
Exclusion
- \- Subjects in another interventional clinical trial will be excluded.
Key Trial Info
Start Date :
April 22 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 2 2024
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT05400447
Start Date
April 22 2022
End Date
April 2 2024
Last Update
May 25 2025
Active Locations (5)
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1
Republic of Turkey Ministry of Health Balıkesir Provincial Health Directorate Ataturk City Hospital
Balıkesir, Altıeylül, Turkey (Türkiye), 10100
2
Ege University Hospital
Izmir, Bornova, Turkey (Türkiye), 35100
3
Republic of Turkey Ministry of Health Izmir Provincial Health Directorate Buca Seyfi Demirsoy Training And Research Hospital
Izmir, Buca, Turkey (Türkiye), 35390
4
Republic of Turkey Ministry of Health Balıkesir Provincial Health Directorate Burhaniye Public Hospital
Balıkesir, Burhaniye, Turkey (Türkiye), 10700