PMCF Study to Evaluate Safety of TIPMED TPM08 Total Knee Prosthesis Systems and TPM Revision Knee Prosthesis Systems

Knee Arthroplasty Clinical Trial

Official title:

Multicenter, Prospective, Observational Post Market Clinical Follow-up Study to Evaluate Safety of TIPMED TPM08 Total Knee Prosthesis Systems and TPM Revision Knee Prosthesis Systems

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05400447
• Other study ID #: INFO TPM08
• Status: Recruiting
• Start date: December 21, 2021
• Est. completion date: December 20, 2023

Study information

• Verified date: February 2022
• Source: TIPMED Medical Device Manufacturing Ltd. Co.
• Contact: Yasemin Onel
• Phone: +9(0)2324793322
• Email: yaseminonel[@]tipmed.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 arthroplasty.

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 completed at each control visit of the participants by investigator in order to assess safety of the TIPMED Knee Prosthesis Systems by success of operation, occurrence of adverse events during procedure or as the effects in 12 months period resulting from TIPMED Knee Prosthesis Systems. CRF will also include questions related to performance and effectiveness of TIPMED Knee Prosthesis Systems.

Participants should be treated according to instructions-for-use of the implants and accessories and according to clinical routine. The devices must have been used exclusively by physicians who are experienced in knee arthroplasty techniques and who are experienced in using the products in operations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: December 20, 2023
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• Subjects in another interventional clinical trial will be excluded.

Related Conditions & MeSH terms

• Knee Arthroplasty

Locations

Country	Name	City	State
Turkey	Republic of Turkey Ministry of Health Balikesir Provincial Health Directorate Ataturk City Hospital	Balikesir	Altieylül
Turkey	Republic of Turkey Ministry of Health Balikesir Provincial Health Directorate Burhaniye Public Hospital	Balikesir	Burhaniye
Turkey	Ege University Hospital	Izmir	Bornova
Turkey	Republic of Turkey Ministry of Health Izmir Provincial Health Directorate Buca Seyfi Demirsoy Training And Research Hospital	Izmir	Buca
Turkey	Republic of Turkey Ministry of Health Izmir Provincial Health Directorate Menemen Public Hospital	Izmir	Menemen

Sponsors (1)

Lead Sponsor	Collaborator
TIPMED Medical Device Manufacturing Ltd. Co.

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety data	Assessment of safety data during 12 months after surgery.	12 months