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

NCT06770153 | Recruiting

• 1 other identifier: TKA-BALANCE
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Knee Injuries

Keywords

Knee prosthesis; prosthesis; knee

Outcome Measures

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)

  at baseline, after 3 months, after 6 months anfer 12 months

Secondary Outcomes (2)

• Hip-Knee-Anke Angle

  at baseline, after 3 months, after 6 months anfer 12 months

• Visual Analogue Scale

  at baseline, after 3 months, after 6 months anfer 12 months

Study Arms (2)

Standard

ACTIVE COMPARATOR

Procedure: standard

Tensor

EXPERIMENTAL

Procedure: Tensor

Interventions

Tensor PROCEDURE

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

Tensor

standard PROCEDURE

primary TKA implantation with ligament balancing without use of the tensioner

Standard

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

MeSH Terms

Conditions

Knee Injuries

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 13, 2025
• Study Start: October 11, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

IT (1)