Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
IRCCS Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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