About this trial
the objective of the present study is to compare the post-operative laxity using stress radiographs and clinical scores in two groups of patients undergoing primary PS TKA with identical prosthetic model performed in two specialized centers, of which one group implanted with standard technique and one group through the intraoperative use of the tensioner
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female subjects candidates for primary cemented total knee prosthesis model Attune PS mobile plate DePuy.
Patients who possess all the psychophysical capabilities to be able to undergo the operation and all the check-ups with radiological tests included (e.g. all patients who are not willing to go to the institute for all the scheduled follow-up visits will be excluded) .
Patients who have signed the "informed consent" approved by the Ethics Committee.
Patients who are aged between 50-85.
Disqualifiers
Social conditions that prevent participation in the study in all its phases (homeless patients, with restrictions on personal freedom, etc.)
Patients suffering from deep venous insufficiency of the lower extremities or with a personal or family history of deep venous thrombosis or pulmonary embolism
Patients with a history of erysipelas in the lower extremities
Patients suffering from neurological or psycho-cognitive disorders
Trial design
Parallel
Treatments tested in this trial
Tensor
Procedure/Surgerybalancing will be carried out using the TEMIS DePuy tensioner and carrying out any releases according to the gap-balancing technique
standard
Procedure/Surgeryprimary TKA implantation with ligament balancing without use of the tensioner
Treatment groups
Trial outcomes
Primary outcomes
radiographical images
take stress x-rays (150 N) of the knee using TELOS to objectively and reproducibly analyze the lift-off (distance between the prosthetic component femoral and the tibial prosthetic component measured in mm)
Secondary outcomes
Hip-Knee-Anke Angle
Hip-Knee-Anke Angle (HKA) on orthostatic panoramic radiographs of the pre- and post-operative lower limbs of the knee.
Visual Analogue Scale
Visual Analogue Scale (VAS) for pain: a scale from 0 to 10 where 0 is no pain and 10 is the worst pain ever
Sponsors and contacts
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