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

May 20, 2025 updated by: TIPMED Medical Device Manufacturing Ltd. Co.

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Altıeylül
      • Balıkesir, Altıeylül, Turkey, 10100
        • Republic of Turkey Ministry of Health Balıkesir Provincial Health Directorate Ataturk City Hospital
    • Bornova
      • Izmir, Bornova, Turkey, 35100
        • Ege University Hospital
    • Buca
      • Izmir, Buca, Turkey, 35390
        • Republic of Turkey Ministry of Health Izmir Provincial Health Directorate Buca Seyfi Demirsoy Training And Research Hospital
    • Burhaniye
      • Balıkesir, Burhaniye, Turkey, 10700
        • Republic of Turkey Ministry of Health Balıkesir Provincial Health Directorate Burhaniye Public Hospital
    • Menemen
      • Izmir, Menemen, Turkey, 35660
        • Republic of Turkey Ministry of Health Izmir Provincial Health Directorate Menemen Public Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All eligible patients, who agree to participate in the study, treated with TIPMED TPM08 Primary Total or Revision Knee Prosthesis Systems will be included.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety data
Time Frame: 12 months
Assessment of safety data during 12 months after surgery.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TIPMED Medical Device Manufacturing Ltd. Co.

Investigators

  • Study Director: Salih Kemal Aktuglu, Ege University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2022

Primary Completion (Actual)

April 2, 2024

Study Completion (Actual)

April 2, 2024

Study Registration Dates

First Submitted

May 27, 2022

First Submitted That Met QC Criteria

May 27, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Actual)

May 25, 2025

Last Update Submitted That Met QC Criteria

May 20, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • INFO TPM08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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