Knee Injuries
Conditions
Keywords
Knee prosthesis, prosthesis, knee
Brief summary
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
Interventions
PROCEDURETensor
balancing will be carried out using the TEMIS DePuy tensioner and carrying out any releases according to the gap-balancing technique
PROCEDUREstandard
primary TKA implantation with ligament balancing without use of the tensioner
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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 * Patients suffering from post-traumatic arthrosis * Patients who have already undergone prosthetic surgery and/or arthrodesis at the level of a lower limb joint * Patients with axial knee deformities \>15° * Pregnant female patients * Patients with rheumatic diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| radiographical images | at baseline, after 3 months, after 6 months anfer 12 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Hip-Knee-Anke Angle | at baseline, after 3 months, after 6 months anfer 12 months | Hip-Knee-Anke Angle (HKA) on orthostatic panoramic radiographs of the pre- and post-operative lower limbs of the knee. |
| Visual Analogue Scale | at baseline, after 3 months, after 6 months anfer 12 months | Visual Analogue Scale (VAS) for pain: a scale from 0 to 10 where 0 is no pain and 10 is the worst pain ever |
Countries
Italy
Outcome results
None listed