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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

190 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-22

Study Completion Date

2024-04-02

Brief Summary

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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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Detailed Description

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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.

Conditions

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Knee Arthroplasty

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.