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NCT Number: NCT06770153

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

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location status: Recruiting

Location contact

Giulio Maria Marcheggiani Muccioli, MD, PhD

CONTACT

[email protected]

+39 051 6366509

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tensor

Procedure

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

standard

Procedure

primary TKA implantation with ligament balancing without use of the tensioner

Primary outcomes

  1. radiographical images

    Time frame: 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 outcomes

  1. Hip-Knee-Anke Angle

    Time frame: 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.

  2. Visual Analogue Scale

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2025
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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