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

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

Study Overview

• Status: Recruiting
• Conditions: Knee Injuries
• Intervention / Treatment: Procedure: standard; Procedure: Tensor

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Recruiting
    • IRCCS Istituto Ortopedico Rizzoli
    • Contact: Giulio Maria Marcheggiani Muccioli, MD, PhD; Phone Number: +39 051 6366509; Email: marcheggianimuccioli@me.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard	Procedure: standard; primary TKA implantation with ligament balancing without use of the tensioner
Experimental: Tensor	Procedure: Tensor; balancing will be carried out using the TEMIS DePuy tensioner and carrying out any releases according to the gap-balancing technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	at baseline, after 3 months, after 6 months anfer 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hip-Knee-Anke Angle	Hip-Knee-Anke Angle (HKA) on orthostatic panoramic radiographs of the pre- and post-operative lower limbs of the knee.	at baseline, after 3 months, after 6 months anfer 12 months
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	at baseline, after 3 months, after 6 months anfer 12 months

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): January 13, 2025

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: knee; prosthesis; Knee prosthesis
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Diagnostic Techniques, Neurological; Neuroimaging; Magnetic Resonance Imaging; Diffusion Magnetic Resonance Imaging; Diffusion Tensor Imaging
• Other Study ID Numbers: TKA-BALANCE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No