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

Not Applicable

Recruiting

• Conditions: Knee Injuries

• Registration Number: NCT06770153
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-11
• Status Verified: 2025-01
• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-07
• Last Update Submitted: 2025-01-07
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13
• Primary Completion: 2026-08
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
radiographical images	at baseline, after 3 months, after 6 months anfer 12 months	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)

Secondary Outcome Measures

Name	Time	Method
Hip-Knee-Anke Angle	at baseline, after 3 months, after 6 months anfer 12 months	Hip-Knee-Anke Angle (HKA) on orthostatic panoramic radiographs of the pre- and post-operative lower limbs of the knee.
Visual Analogue Scale	at baseline, after 3 months, after 6 months anfer 12 months	Visual Analogue Scale (VAS) for pain: a scale from 0 to 10 where 0 is no pain and 10 is the worst pain ever

Trial Locations

Locations (1)

IRCCS Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy