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

NCT ID: NCT03448198

Last Updated: 2018-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-16

Study Completion Date

2014-11-16

Brief Summary

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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

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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.

Conditions

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Knee Osteoarthritis

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

open label

Study Groups

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Knee arthritis

Total knee replacement

Group Type OTHER

Total knee replacement

Intervention Type PROCEDURE

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

Interventions

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Total knee replacement

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Claudio Belvedere

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Ensini, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Ortopedico Rizzoli

Locations

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Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 9117525 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12931800 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17431587 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15534514 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12770636 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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39521/2012

Identifier Type: -

Identifier Source: org_study_id