NCT03448198

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2014

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

1.5 years

First QC Date

February 9, 2018

Last Update Submit

February 21, 2018

Conditions

Knee Osteoarthritis

Keywords

total knee arthroplastypatellar resurfacingpatellar trackingpatello-femoral joint kinematicssurgical navigationcomputer-aided surgery

Outcome Measures

Primary Outcomes (2)

  • Knee prosthesis rotational alignment

    Rotational (in deg) positioning of femur, tibia and patella prosthesis components.

    At time of surgery

  • Knee prosthesis translational alignment

    Translational (in mm) positioning of femur, tibia and patella prosthesis components.

    At time of surgery

Secondary Outcomes (4)

  • Intra-operative knee joint rotations

    At time of surgery

  • Intra-operative knee joint translations

    At time of surgery

  • Post-operative knee joint rotations

    24 months

  • Post-operative knee joint translations

    24 months

Study Arms (1)

Knee arthritis

OTHER

Total knee replacement

Procedure: Total knee replacement

Interventions

Total knee replacementPROCEDURE

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

Knee arthritis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (5)

  • 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.

    PMID: 9117525BACKGROUND

  • 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.

    PMID: 12931800BACKGROUND

  • 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.

    PMID: 17431587BACKGROUND

  • 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.

    PMID: 15534514BACKGROUND

  • 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.

    PMID: 12770636BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Andrea Ensini, MD

    Istituto Ortopedico Rizzoli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
open label
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 9, 2018

First Posted

February 28, 2018

Study Start

November 16, 2012

Primary Completion

May 16, 2014

Study Completion

November 16, 2014

Last Updated

February 28, 2018

Record last verified: 2018-02

Locations

IT(1)