Comparison Between the Use of the Tensioner and Standard Surgical Technique for Ligament Balancing of Total Knee Prostheses

ConditionKnee Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorIstituto Ortopedico Rizzoli

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Tensor

    Procedure/Surgery

    balancing will be carried out using the TEMIS DePuy tensioner and carrying out any releases according to the gap-balancing technique

  • standard

    Procedure/Surgery

    primary TKA implantation with ligament balancing without use of the tensioner

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: StandardActive comparator 1 intervention
Group B: TensorExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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

Other outcomes

Sponsors and contacts

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