Validation of a New Technique for the Evaluation of the Patello-femoral Joint Kinematics (CINE-FEMORO)

February 21, 2018 updated by: Claudio Belvedere, Istituto Ortopedico Rizzoli
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Knee arthritis
Total knee replacement
Procedure: Total knee replacement
Primary knee gonarthrosis treated with navigated total knee replacement and computer-assisted patellar replacement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee prosthesis rotational alignment
Time Frame: At time of surgery
Rotational (in deg) positioning of femur, tibia and patella prosthesis components.
At time of surgery
Knee prosthesis translational alignment
Time Frame: At time of surgery
Translational (in mm) positioning of femur, tibia and patella prosthesis components.
At time of surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Investigators

  • Principal Investigator: Andrea Ensini, MD, Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2012

Primary Completion (Actual)

May 16, 2014

Study Completion (Actual)

November 16, 2014

Study Registration Dates

First Submitted

February 9, 2018

First Submitted That Met QC Criteria

February 21, 2018

First Posted (Actual)

February 28, 2018

Study Record Updates

Last Update Posted (Actual)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 21, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 39521/2012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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