Clinical trial NCT05400447: PMCF Study to Evaluate Safety of TIPMED TPM08 Total Knee Prosthesis Systems and TPM Revision Knee Prosthesis Systems
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Arthroplasty
Keywords: Knee Prosthesis
Total Knee Arthroplasty
Revision Knee Arthroplasty
Lead sponsor: TIPMED Medical Device Manufacturing Ltd. Co.
Sponsor class: INDUSTRY
First posted: 2022-06-01
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety data
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Balıkesir
country: Turkey
facility: Republic of Turkey Ministry of Health Balıkesir Provincial Health Directorate Ataturk City Hospital
state: Altıeylül
city: Izmir
country: Turkey
facility: Ege University Hospital
state: Bornova
city: Izmir
country: Turkey
facility: Republic of Turkey Ministry of Health Izmir Provincial Health Directorate Buca Seyfi Demirsoy Training And Research Hospital
state: Buca
city: Balıkesir
country: Turkey
facility: Republic of Turkey Ministry of Health Balıkesir Provincial Health Directorate Burhaniye Public Hospital
state: Burhaniye
city: Izmir
country: Turkey
facility: Republic of Turkey Ministry of Health Izmir Provincial Health Directorate Menemen Public Hospital
state: Menemen
Study officials:
affiliation: Ege University Hospital
name: Salih Kemal Aktuglu
role: STUDY_DIRECTOR
References: