NCT05400447

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 27, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2024

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

1.9 years

First QC Date

May 27, 2022

Last Update Submit

May 20, 2025

Conditions

Knee Arthroplasty

Keywords

Knee ProsthesisTotal Knee ArthroplastyRevision Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Safety data

    Assessment of safety data during 12 months after surgery.

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • \- Subjects in another interventional clinical trial will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Republic of Turkey Ministry of Health Balıkesir Provincial Health Directorate Ataturk City Hospital

Balıkesir, Altıeylül, 10100, Turkey (Türkiye)

Location

Ege University Hospital

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

Republic of Turkey Ministry of Health Izmir Provincial Health Directorate Buca Seyfi Demirsoy Training And Research Hospital

Izmir, Buca, 35390, Turkey (Türkiye)

Location

Republic of Turkey Ministry of Health Balıkesir Provincial Health Directorate Burhaniye Public Hospital

Balıkesir, Burhaniye, 10700, Turkey (Türkiye)

Location

Republic of Turkey Ministry of Health Izmir Provincial Health Directorate Menemen Public Hospital

Izmir, Menemen, 35660, Turkey (Türkiye)

Location

Study Officials

  • Salih Kemal Aktuglu

    Ege University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2022

First Posted

June 1, 2022

Study Start

April 22, 2022

Primary Completion

April 2, 2024

Study Completion

April 2, 2024

Last Updated

May 25, 2025

Record last verified: 2025-05

Locations

TU(5)