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
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two surgical techniques for ligament balancing in patients receiving primary posterior-stabilized total knee arthroplasty (TKA) using the same prosthetic model. The study aims to evaluate post-operative joint laxity using stress radiographs and clinical scores in two patient groups, one treated with the standard technique and the other with the intraoperative use of a tensioner. This comparison is conducted across two specialized centers to assess differences in outcomes. The study involves two groups: one undergoing standard TKA implantation with ligament balancing performed without a tensioner, and the other using the TEMIS DePuy tensioner to assist with balancing following the gap-balancing technique. Both groups receive the same cemented Attune PS mobile plate prosthesis model. The trial is randomized and does not involve blinding. Participants will have radiographic images taken at baseline, and again at 3, 6, and 12 months after surgery to measure post-operative laxity. Additional assessments include measuring the Hip-Knee-Ankle angle and using a visual analogue scale at the same time points. Patients must attend all scheduled follow-up visits for these evaluations. The total participation duration spans at least 12 months after surgery, allowing researchers to monitor recovery and knee function over time.
CONDITIONS
Brief 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 subjects candidates for primary cemented total knee prosthesis model Attune PS mobile plate DePuy
- Patients who have the psychophysical ability to undergo the operation and all scheduled check-ups including radiological tests
- Patients who have signed the informed consent approved by the Ethics Committee
- Patients aged between 50 and 85 years
You will not qualify if you...
- Social conditions preventing participation in all study phases (e.g., homelessness, restrictions on personal freedom)
- Deep venous insufficiency of the lower extremities or personal/family history of deep venous thrombosis or pulmonary embolism
- History of erysipelas in the lower extremities
- Neurological or psycho-cognitive disorders
- Post-traumatic arthrosis
- Prior prosthetic surgery or arthrodesis on a lower limb joint
- Axial knee deformities greater than 15 degrees
- Pregnant female patients
- Rheumatic diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week or until discharge
Participants undergo total knee prosthesis surgery using either the tensioner or standard surgical technique for ligament balancing, followed by immediate post-operative care.
1 surgical visit and daily post-operative visits during hospital stay
Duration - 12 months
Participants attend scheduled follow-up visits for clinical assessments and radiographical imaging to monitor recovery and outcomes after surgery.
Visits at baseline, 3 months, 6 months, and 12 months post-surgery
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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