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Validation of a New Technique for the Evaluation of the Patello-femoral Joint Kinematics

Validation of a New Technique for the Evaluation of the Patello-femoral Joint Kinematics

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03448198
Acronym
CINE-FEMORO
Enrollment
20
Registered
2018-02-28
Start date
2012-11-16
Completion date
2014-11-16
Last updated
2018-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

total knee arthroplasty, patellar resurfacing, patellar tracking, patello-femoral joint kinematics, surgical navigation, computer-aided surgery

Brief summary

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.

Detailed description

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.

Interventions

PROCEDURETotal knee replacement

Primary knee gonarthrosis treated with navigated total knee replacement and computer-assisted patellar replacement.

Sponsors

Istituto Ortopedico Rizzoli
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

open label

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients with unilateral primary knee arthrosis indicated for total knee replacement. * Patients able to understand the protocol and to sign the informed consent.

Exclusion criteria

* Patients with indications for revision surgery. * Patients with patellectomy. * Child-bearing female.

Design outcomes

Primary

MeasureTime frameDescription
Knee prosthesis rotational alignmentAt time of surgeryRotational (in deg) positioning of femur, tibia and patella prosthesis components.
Knee prosthesis translational alignmentAt time of surgeryTranslational (in mm) positioning of femur, tibia and patella prosthesis components.

Secondary

MeasureTime frameDescription
Intra-operative knee joint rotationsAt time of surgeryAssessed rotations (in deg): tibio-femoral flexion-extension, ad-abduction and internal-external rotation; patello-femoral flexion-extension, medio-lateral rotation and tilt.
Intra-operative knee joint translationsAt time of surgeryAssessed translations (in mm): tibio-femoral and patello-femoral anterio-posterior, medial-lateral and proximal-distal translations.
Post-operative knee joint rotations24 monthsAssessed rotations (in deg): tibio-femoral flexion-extension, ad-abduction and internal-external rotation; patello-femoral flexion-extension, medio-lateral rotation and tilt.
Post-operative knee joint translations24 monthsAssessed translations (in mm): tibio-femoral and patello-femoral anterio-posterior, medial-lateral and proximal-distal translations.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026