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

NCT ID: NCT06770153

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-11
• Study Completion Date: 2026-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard

Group Type: ACTIVE_COMPARATOR

standard

Intervention Type: PROCEDURE

primary TKA implantation with ligament balancing without use of the tensioner

Tensor

Group Type: EXPERIMENTAL

Tensor

Intervention Type: PROCEDURE

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

Interventions

Tensor

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

Intervention Type: PROCEDURE

standard

primary TKA implantation with ligament balancing without use of the tensioner

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Giulio Maria Marcheggiani Muccioli, MD, PhD

Role: primary

marcheggianimuccioli@me.com

+39 051 6366509

Other Identifiers

TKA-BALANCE

Identifier Type: -

Identifier Source: org_study_id