Comparing two techniques for knee prosthesis surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of a tensioner device versus standard surgical techniques in balancing ligaments during total knee arthroplasty. Patients undergoing primary cemented total knee prosthesis will be divided into two groups, with one receiving the standard technique and the other utilizing the tensioner. Post-operative laxity will be assessed through stress radiographs and clinical scores to determine which method yields better outcomes. The study will take place at specialized centers with a focus on the Attune PS mobile plate model.

Why it matters

Who can join: the full rules

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

Where it's running

• IRCCS Istituto Ortopedico Rizzoli
  Bologna, Italy Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.