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Completed

NCT Number: NCT05400447

PMCF 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Republic of Turkey Ministry of Health Balıkesir Provincial Health Directorate Ataturk City Hospital, Balıkesir, Altıeylül, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Safety data

    Time frame: 12 months

    Assessment of safety data during 12 months after surgery.

Sponsors and collaborators

Lead sponsor

TIPMED Medical Device Manufacturing Ltd. Co.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 1, 2022
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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