An interventional study of Tensor and standard in Knee Injuries, 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 2026-01-26.
Sponsored by Istituto Ortopedico Rizzoli · Not applicable, Interventional, and Treatment
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
249 studies on the registry are indexed under Knee Injuries; 48 are open to participants now.
This study's planned enrollment of 200 is above the median of 50 across 160 interventional studies indexed under Knee Injuries.
Browse Knee Injuries studies →Istituto Ortopedico Rizzoli is the lead sponsor of 298 studies on the registry; 102 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: standard
Procedure: Tensor
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
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)
Time frame: at baseline, after 3 months, after 6 months anfer 12 months
Hip-Knee-Anke Angle
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
Visual Analogue Scale (VAS) for pain: a scale from 0 to 10 where 0 is no pain and 10 is the worst pain ever
Time frame: at baseline, after 3 months, after 6 months anfer 12 months
Plan to share: Undecided
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Istituto Ortopedico Rizzoli