Recruiting NCT06770153
Comparison Between the Use of the Tensioner and Standard Surgical Technique for Ligament Balancing of Total Knee Prostheses
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tensor, standard.
- Who it may be relevant to
- Registry conditions: Knee Injuries. Basic parameters: 50 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Procedure Tensor
balancing will be carried out using the TEMIS DePuy tensioner and carrying out any releases according to the gap-balancing technique - Procedure standard
primary TKA implantation with ligament balancing without use of the tensioner
Primary outcome measures
- radiographical images [Time frame: at baseline, after 3 months, after 6 months anfer 12 months]
Secondary outcome measures (2)
- Hip-Knee-Anke Angle [Time frame: at baseline, after 3 months, after 6 months anfer 12 months]
- Visual Analogue Scale [Time frame: at baseline, after 3 months, after 6 months anfer 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- IRCCS Istituto Ortopedico Rizzoli — Bologna
Identifiers
NCT: NCT06770153 · TKA-BALANCE