Status:
RECRUITING
Comparison of Custom and Standard Total Knee Replacements
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40-70 years
Phase:
NA
Brief Summary
Total knee arthroplasty (TKA) is the most common surgery in North America and the second most common in Europe. One of the most critical issues for stability and durability of the interventional is th...
Eligibility Criteria
Inclusion
- Male and female subjects older than 40 years and younger than 70 years (≥ 40 age ≤ 70 years) candidates for primary cemented total knee replacement.
- Consenting patients and able to complete scheduled study procedures and follow-up evaluations.
- Patients who have signed the "informed consent" approved by the Ethics Committee.
Exclusion
- Social conditions (homeless patients, with restrictions on personal freedom)
- ASA 3
- Deep venous insufficiency Lower limbs
- History of Erisipelas lower limbs
- Neurological or psychocognitive disorders
- Neurological diseases
- Post-traumatic arthritis
- Axial deformities of the knee \>10°
- Personal or family history of DVT or EP
- Prosthetic and/or arthrodesis surgeries at another joint of the lower extremities lower limb except that candidate for knee prosthesis
- Pregnant women
- Patients with rheumatic diseases
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06122727
Start Date
March 1 2023
End Date
April 30 2026
Last Update
July 30 2025
Active Locations (1)
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1
IRCCS Istituto Ortopedico Rizzoli
Bologna, Italy, 40136