Comparing two techniques for knee prosthesis surgery
Comparison Between the Use of the Tensioner and Standard Surgical Technique for Ligament Balancing of Total Knee Prostheses
NA · Istituto Ortopedico Rizzoli · NCT06770153
This study is testing whether using a special tensioner device during knee replacement surgery helps patients have better results compared to the standard surgery method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli (other) |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06770153 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a tensioner device versus standard surgical techniques in balancing ligaments during total knee arthroplasty. Patients undergoing primary cemented total knee prosthesis will be divided into two groups, with one receiving the standard technique and the other utilizing the tensioner. Post-operative laxity will be assessed through stress radiographs and clinical scores to determine which method yields better outcomes. The study will take place at specialized centers with a focus on the Attune PS mobile plate model.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 50-85 who are scheduled for primary cemented total knee prosthesis surgery.
Not a fit: Patients with social conditions preventing participation, or those with specific medical histories such as deep venous insufficiency or neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced post-operative complications for patients receiving knee prostheses.
How similar studies have performed: While this approach is being tested, similar studies have shown varying degrees of success in improving surgical techniques for knee prostheses.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bologna
- IRCCS Istituto Ortopedico Rizzoli — Bologna, Italy (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Knee Injuries, Knee prosthesis, prosthesis, knee