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

Launched by ISTITUTO ORTOPEDICO RIZZOLI · Jan 7, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at two different methods for balancing ligaments during total knee replacement surgery. The goal is to see if using a special device called a tensioner leads to better stability and outcomes compared to the standard surgical technique. Researchers will compare the results by taking special X-rays and assessing how patients feel after their surgery.

To participate in this study, patients must be between 50 and 85 years old and be candidates for a specific type of knee prosthesis. They should be able to attend follow-up visits and have signed consent to take part in the trial. Participants can expect to have their knee function and stability evaluated over time, helping to improve future treatment options for knee injuries. It’s important to note that certain health conditions, like previous knee surgeries or specific vascular issues, may exclude individuals from participating.

Gender

ALL

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