Actively Recruiting

Phase Not Applicable
Age: 50Years - 85Years
All Genders
NCT06770153

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

Led by Istituto Ortopedico Rizzoli · Updated on 2026-01-26

200

Participants Needed

1

Research Sites

102 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 50Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female candidates for primary cemented total knee prosthesis model Attune PS mobile plate DePuy
  • Must have the physical and mental ability to undergo surgery and all postoperative radiological and clinical follow-ups
  • Must have signed informed consent approved by the Ethics Committee
  • Age between 50 and 85 years
Not Eligible

You will not qualify if you...

  • Social conditions preventing participation throughout the study (e.g., homelessness, restrictions on personal freedom)
  • History or presence of deep venous insufficiency, deep venous thrombosis, or pulmonary embolism in the lower limbs
  • History of erysipelas in the lower extremities
  • Neurological or psycho-cognitive disorders
  • Post-traumatic arthrosis
  • Previous prosthetic surgery or arthrodesis of a lower limb joint
  • Axial knee deformity greater than 15 degrees
  • Pregnant women
  • Rheumatic diseases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

IRCCS Istituto Ortopedico Rizzoli

Bologna, Italy, 40136

Actively Recruiting

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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