IRCCS Istituto Ortopedico Rizzoli
Bologna, 40136, Italy
Location status: Recruiting
NCT Number: NCT06770153
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
Interested in participating?
Request Info50 year–85 year
All sexes
Interventional
Not applicable
Bologna, 40136, Italy
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
balancing will be carried out using the TEMIS DePuy tensioner and carrying out any releases according to the gap-balancing technique
primary TKA implantation with ligament balancing without use of the tensioner
Time frame: 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)
Time frame: 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.
Time frame: 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
Istituto Ortopedico Rizzoli
Other
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