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 range50 Years – 85 Years

SexALL

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

Knee injury and Osteoarthritis Outcome Score

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 range50 Years – 85 Years

SexALL

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

Knee injury and Osteoarthritis Outcome Score