Istituto Ortopedico Rizzoli
Bologna, 40136, Italy
NCT Number: NCT03448198
The objective of this study is to validate a new technique for intraoperative quantification of the patello-femoral joint kinematics in patients undergoing total knee replacement, and for postoperative quantification of implanted knee and general lower limb activity, along with relevant muscle dynamics.
Looking for future studies?
Notify MeAll sexes
Interventional
Not applicable
Bologna, 40136, Italy
In total knee replacement with patellar resurfacing, the patellar bone preparation and relevant component positioning, including relevant motion assessments, are still not navigated, and only femoral/tibial component positioning is supported by computer-assistance. After surgery, anterior knee pain is generally reported and this may due to prosthesis component mal-positioning, including the patella, and, ultimately, this may result in revision arthroplasty. Within computer-assisted surgery, surgical navigated system have been introduced to monitor femur and tibia prosthesis implantation and to assess tibio-femoral joint kinematics. In this context, the patella is still disregarded or limitedly considered, whereas it is still debated if the patella should be resurfaced in total knee replacement. Recently, new navigation-based procedures have been tested to allow the intra-operative monitoring of patellar-based data for more proper patellar resurfacing; at follow-up under active conditions, video-fluoroscopy, so far used to assess general tibio-femoral kinematics, offers the potentials for patellar motion tracking.
The possibility in vivo to perform intra-operative evaluations of the patello-femoral joint data, i.e. including patellar bone morphology and motion, via computer assisted procedures during surgery would allow the surgeon to have a more complete comprehension of the knee functioning in patients undergoing total knee replacement; these procedures, along with derived data, can act as a support in for the most critical surgical actions in terms of femoral/tibial prosthesis component implantation and related patellar resurfacing. Furthermore, at post-operative follow-ups via fluoroscopic acquisitions and gait analysis, it is possible to evaluate how the implant is able to recover, or not, the normative physiological motion at both tibio-femoral and patello-femoral joint.
The goal of this study is to validate a new technique for intra-operative quantification of the patello-femoral joint kinematics in patients undergoing total knee replacement, and for postoperative quantification of implanted knee and general lower limb activity, along with relevant muscle dynamics.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Primary knee gonarthrosis treated with navigated total knee replacement and computer-assisted patellar replacement.
Time frame: At time of surgery
Rotational (in deg) positioning of femur, tibia and patella prosthesis components.
Time frame: At time of surgery
Translational (in mm) positioning of femur, tibia and patella prosthesis components.
Time frame: At time of surgery
Assessed rotations (in deg): tibio-femoral flexion-extension, ad-abduction and internal-external rotation; patello-femoral flexion-extension, medio-lateral rotation and tilt.
Time frame: At time of surgery
Assessed translations (in mm): tibio-femoral and patello-femoral anterio-posterior, medial-lateral and proximal-distal translations.
Time frame: 24 months
Assessed rotations (in deg): tibio-femoral flexion-extension, ad-abduction and internal-external rotation; patello-femoral flexion-extension, medio-lateral rotation and tilt.
Time frame: 24 months
Assessed translations (in mm): tibio-femoral and patello-femoral anterio-posterior, medial-lateral and proximal-distal translations.
Istituto Ortopedico Rizzoli
Other
Acronym: CINE-FEMORO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07327190
Arthritis, Joint Diseases
Kütahya, Turkey (Türkiye)
View Trial DetailsNCT04492670
Arthritis, Joint Diseases
Hong Kong
View Trial DetailsNCT04653896
Arthritis, Joint Diseases
The Bronx, New York, United States
View Trial DetailsNCT07717957
Arthritis, Joint Diseases
Kuantan, Pahang, Malaysia
View Trial Details