Status:
COMPLETED
Evaluation of the TruMatch® System in Knee Prosthetic Surgery
Lead Sponsor:
University of Milan
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
Patient specific instrumentation is an alternative to conventional intra- and extra-medullary guides to perform the femoral and tibial cuts in total knee replacement (TKR). This instrumentation could...
Detailed Description
Good alignment after a TKR leads to faster rehabilitation, better clinical outcomes and lower revision rate. A correct rotational (axial) alignment reduces patellofemoral complications, polyethylene w...
Eligibility Criteria
Inclusion
- Age \> 40, \<80
- Indication for TKR
- Surgical indication for Attune®, posterior stabilized, fixed bearing TKR
- Patients signed written informed consent
Exclusion
- Age \> 80, \< 40
- TKR revision surgery
- Metal devices within 8 cm from knee articular surfaces
- Fixed knee deformities greater than 15° in varus, valgus, flexion or tibial slope.
- Knee ankylosis
- Previous tibial osteotomy surgery
- Informed consent not accepted
- Serious comorbidity
- Active infections
- Pregnant or breastfeeding women
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2017
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01876654
Start Date
June 1 2013
End Date
April 30 2017
Last Update
May 12 2017
Active Locations (1)
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1
Unità Operativa Ortopedia II, Policlinico San Donato (Istituto di Ricovero e Cura a Carattere Scientifico)
San Donato Milanese, MI, Italy, 20097