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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05400447

Enrollment

190

Registered

2022-06-01

Start date

2022-04-22

Completion date

2024-04-02

Last updated

2025-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Arthroplasty

Keywords

Knee Prosthesis, Total Knee Arthroplasty, Revision Knee Arthroplasty

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Turkey (Türkiye)

Outcome results