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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Total knee replacement
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring total knee arthroplasty, patellar resurfacing, patellar tracking, patello-femoral joint kinematics, surgical navigation, computer-aided surgery

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Istituto Ortopedico Rizzoli

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Knee arthritis

Arm Description

Total knee replacement

Outcomes

Primary Outcome Measures

Knee prosthesis rotational alignment
Rotational (in deg) positioning of femur, tibia and patella prosthesis components.
Knee prosthesis translational alignment
Translational (in mm) positioning of femur, tibia and patella prosthesis components.

Secondary Outcome Measures

Intra-operative knee joint rotations
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
Assessed translations (in mm): tibio-femoral and patello-femoral anterio-posterior, medial-lateral and proximal-distal translations.
Post-operative knee joint rotations
Assessed 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 translations
Assessed translations (in mm): tibio-femoral and patello-femoral anterio-posterior, medial-lateral and proximal-distal translations.

Full Information

First Posted
February 9, 2018
Last Updated
February 21, 2018
Sponsor
Istituto Ortopedico Rizzoli
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1. Study Identification

Unique Protocol Identification Number
NCT03448198
Brief Title
Validation of a New Technique for the Evaluation of the Patello-femoral Joint Kinematics
Acronym
CINE-FEMORO
Official Title
Validation of a New Technique for the Evaluation of the Patello-femoral Joint Kinematics
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 16, 2012 (Actual)
Primary Completion Date
May 16, 2014 (Actual)
Study Completion Date
November 16, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
total knee arthroplasty, patellar resurfacing, patellar tracking, patello-femoral joint kinematics, surgical navigation, computer-aided surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
open label
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Knee arthritis
Arm Type
Other
Arm Description
Total knee replacement
Intervention Type
Procedure
Intervention Name(s)
Total knee replacement
Intervention Description
Primary knee gonarthrosis treated with navigated total knee replacement and computer-assisted patellar replacement.
Primary Outcome Measure Information:
Title
Knee prosthesis rotational alignment
Description
Rotational (in deg) positioning of femur, tibia and patella prosthesis components.
Time Frame
At time of surgery
Title
Knee prosthesis translational alignment
Description
Translational (in mm) positioning of femur, tibia and patella prosthesis components.
Time Frame
At time of surgery
Secondary Outcome Measure Information:
Title
Intra-operative knee joint rotations
Description
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
Title
Intra-operative knee joint translations
Description
Assessed translations (in mm): tibio-femoral and patello-femoral anterio-posterior, medial-lateral and proximal-distal translations.
Time Frame
At time of surgery
Title
Post-operative knee joint rotations
Description
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
Title
Post-operative knee joint translations
Description
Assessed translations (in mm): tibio-femoral and patello-femoral anterio-posterior, medial-lateral and proximal-distal translations.
Time Frame
24 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Ensini, MD
Organizational Affiliation
Istituto Ortopedico Rizzoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
9117525
Citation
Cutbill JW, Ladly KO, Bray RC, Thorne P, Verhoef M. Anterior knee pain: a review. Clin J Sport Med. 1997 Jan;7(1):40-5. doi: 10.1097/00042752-199701000-00008.
Results Reference
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PubMed Identifier
12931800
Citation
Sparmann M, Wolke B, Czupalla H, Banzer D, Zink A. Positioning of total knee arthroplasty with and without navigation support. A prospective, randomised study. J Bone Joint Surg Br. 2003 Aug;85(6):830-5.
Results Reference
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PubMed Identifier
17431587
Citation
Belvedere C, Catani F, Ensini A, Moctezuma de la Barrera JL, Leardini A. Patellar tracking during total knee arthroplasty: an in vitro feasibility study. Knee Surg Sports Traumatol Arthrosc. 2007 Aug;15(8):985-93. doi: 10.1007/s00167-007-0320-1. Epub 2007 Apr 13.
Results Reference
background
PubMed Identifier
15534514
Citation
Burnett RS, Haydon CM, Rorabeck CH, Bourne RB. Patella resurfacing versus nonresurfacing in total knee arthroplasty: results of a randomized controlled clinical trial at a minimum of 10 years' followup. Clin Orthop Relat Res. 2004 Nov;(428):12-25.
Results Reference
background
PubMed Identifier
12770636
Citation
Fantozzi S, Benedetti MG, Leardini A, Banks SA, Cappello A, Assirelli D, Catani F. Fluoroscopic and gait analysis of the functional performance in stair ascent of two total knee replacement designs. Gait Posture. 2003 Jun;17(3):225-34. doi: 10.1016/s0966-6362(02)00096-6.
Results Reference
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Validation of a New Technique for the Evaluation of the Patello-femoral Joint Kinematics

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