RecruitingNot Applicable

Evaluation of the Clinical Outcomes of the Total Knee ps Prosthesis Implanted With the Use of Inertial Sensors

Italy40 participantsStarted 2023-01-13

Plain-language summary

evaluate the clinical outcome of the implantation of a specific primary TKA model implanted with the aid of inertial sensors for the execution of bone cuts through the administration of questionnaires for the calculation of clinical-functional scores;

Who can participate

Age range

50 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male and female subjects 50 years of age or older and less than 85 years of age (\>50 and \<85 years) who are candidates for primary cemented total knee replacement based on physical examination and medical history, including diagnosis of severe knee pain and disability due to at least one of the following causes:
. Patients consent and able to complete scheduled study procedures and follow-up assessments.
. Patients informed about the nature of the study who signed the "informed consent" approved by the ethics committee.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Knee Society Score

Timeframe: at baseline (day 0)

Knee Society Score

Timeframe: 6 months

Knee Society Score

Timeframe: 12 months

Knee Society Score

Timeframe: 24 months

Western Ontario and McMaster Universities Arthritis Index

Timeframe: at baseline (day 0)

Western Ontario and McMaster Universities Arthritis Index

Timeframe: 6 months

Western Ontario and McMaster Universities Arthritis Index

Timeframe: 12 months

Western Ontario and McMaster Universities Arthritis Index

Timeframe: 24 months

Trial details

NCT IDNCT06321042

SponsorIstituto Ortopedico Rizzoli

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-01

Contact for this trial

Stefano Zaffagnini, Prof

0516366075 stefano.zaffagnini@unibo.it

View on ClinicalTrials.gov More Prosthesis Durability trials

Who can participate

Age range

50 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male and female subjects 50 years of age or older and less than 85 years of age (\>50 and \<85 years) who are candidates for primary cemented total knee replacement based on physical examination and medical history, including diagnosis of severe knee pain and disability due to at least one of the following causes:
. Patients consent and able to complete scheduled study procedures and follow-up assessments.
. Patients informed about the nature of the study who signed the "informed consent" approved by the ethics committee.

What they're measuring

Knee Society Score

Timeframe: at baseline (day 0)

Knee Society Score

Timeframe: 6 months

Knee Society Score

Timeframe: 12 months

Knee Society Score

Timeframe: 24 months

Western Ontario and McMaster Universities Arthritis Index

Timeframe: at baseline (day 0)

Western Ontario and McMaster Universities Arthritis Index

Timeframe: 6 months

Western Ontario and McMaster Universities Arthritis Index

Timeframe: 12 months

Western Ontario and McMaster Universities Arthritis Index

Timeframe: 24 months