An observational study in Prosthesis Durability, sponsored by Istituto Ortopedico Rizzoli. Recruiting at 1 site in Italy. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Istituto Ortopedico Rizzoli · Observational
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;
119 studies on the registry are indexed under Prosthesis Failure; 35 are open to participants now.
This study's planned enrollment of 40 is below the median of 119 across 49 observational studies indexed under Prosthesis Failure.
Browse Prosthesis Failure studies →Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 103 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients candidates to TKA surgery
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Knee arthroplasty
Knee arthroplasty surgery with perseus orthokey alignment device
Knee Society Score
Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100
Time frame: at baseline (day 0)
Knee Society Score
Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100
Time frame: 6 months
Knee Society Score
Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100
Time frame: 12 months
Knee Society Score
Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100
Time frame: 24 months
Western Ontario and McMaster Universities Arthritis Index
The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96
Time frame: at baseline (day 0)
Western Ontario and McMaster Universities Arthritis Index
The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96
Time frame: 6 months
Western Ontario and McMaster Universities Arthritis Index
The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96
Time frame: 12 months
Western Ontario and McMaster Universities Arthritis Index
The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96
Time frame: 24 months
Knee injury and Osteoarthritis Outcome Score
The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). the score goes from 0 to 100
Time frame: at baseline (day 0)
Knee injury and Osteoarthritis Outcome Score
The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). the score goes from 0 to 100
Time frame: 6 months
Knee injury and Osteoarthritis Outcome Score
The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). the score goes from 0 to 100
Time frame: 12 months
Knee injury and Osteoarthritis Outcome Score
The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). the score goes from 0 to 100
Time frame: 24 months
36-Item Short Form Health Survey
is a valid and reliable tool for measuring health outcomes in patients with musculoskeletal pain, but its sensitivity to clinical changes in patients with specific disorders may be limited, rated on a scale of 0 to 100, with 0 and 100 being minimum and maximum possible scores.
Time frame: at baseline (day 0)
36-Item Short Form Health Survey
is a valid and reliable tool for measuring health outcomes in patients with musculoskeletal pain, but its sensitivity to clinical changes in patients with specific disorders may be limited, rated on a scale of 0 to 100, with 0 and 100 being minimum and maximum possible scores.
Time frame: 6 months
36-Item Short Form Health Survey
is a valid and reliable tool for measuring health outcomes in patients with musculoskeletal pain, but its sensitivity to clinical changes in patients with specific disorders may be limited, rated on a scale of 0 to 100, with 0 and 100 being minimum and maximum possible scores.
Time frame: 12 months
36-Item Short Form Health Survey
is a valid and reliable tool for measuring health outcomes in patients with musculoskeletal pain, but its sensitivity to clinical changes in patients with specific disorders may be limited, rated on a scale of 0 to 100, with 0 and 100 being minimum and maximum possible scores.
Time frame: 24 months
Forgotten joint score
a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint
Time frame: at baseline (day 0)
Forgotten joint score
a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint
Time frame: 6 months
Forgotten joint score
a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint
Time frame: 12 months
Forgotten joint score
a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint
Time frame: 24 months
Radiographic evaluation of prosthetic femoral component positioning
measurement of prosthetic femoral component alignment according to femoral mechanical axis
Time frame: 5 days after index surgery
Started Jan 2023 (actual). Primary completion is estimated for Jan 2027, 48 months after the start.
Of 28 observational studies under Prosthesis Failure, half reached primary completion within 181 months of starting (the median), counting those still running; a quarter within 57 and three quarters within 184. This study's planned 48 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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