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

Completed

• Conditions: Knee Arthroplasty

• Registration Number: NCT05400447
• Lead Sponsor: TIPMED Medical Device Manufacturing Ltd. Co.

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 arthroplasty.

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 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.

Study Timeline

• Study Start: 2022-04-22
• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-05-27
• Study First Posted: 2022-06-01
• Primary Completion: 2024-04-02
• Study Completion: 2024-04-02
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety data	12 months	Assessment of safety data during 12 months after surgery.

Trial Locations

Locations (5)

Republic of Turkey Ministry of Health Balıkesir Provincial Health Directorate Ataturk City Hospital; 🇹🇷 Balıkesir, Altıeylül, 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 Balıkesir Provincial Health Directorate Burhaniye Public Hospital; 🇹🇷 Balıkesir, Burhaniye, Turkey

Republic of Turkey Ministry of Health Izmir Provincial Health Directorate Menemen Public Hospital; 🇹🇷 Izmir, Menemen, Turkey