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

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Procedure: Total knee replacement

• Registration Number: NCT03448198
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Study Timeline

• Study Start: 2012-11-16
• Primary Completion: 2014-05-16
• Study Completion: 2014-11-16
• Status Verified: 2018-02
• Study First Submitted: 2018-02-09
• Study First Submitted QC: 2018-02-21
• Last Update Submitted: 2018-02-21
• Study First Posted: 2018-02-28
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Knee arthritis	Total knee replacement	Total knee replacement

Primary Outcome Measures

Name	Time	Method
Knee prosthesis translational alignment	At time of surgery	Translational (in mm) positioning of femur, tibia and patella prosthesis components.
Knee prosthesis rotational alignment	At time of surgery	Rotational (in deg) positioning of femur, tibia and patella prosthesis components.

Secondary Outcome Measures

Name	Time	Method
Post-operative knee joint translations	24 months	Assessed translations (in mm): tibio-femoral and patello-femoral anterio-posterior, medial-lateral and proximal-distal translations.
Post-operative knee joint rotations	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.
Intra-operative knee joint translations	At time of surgery	Assessed translations (in mm): tibio-femoral and patello-femoral anterio-posterior, medial-lateral and proximal-distal translations.
Intra-operative knee joint rotations	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.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy