NCT01022099

Brief Summary

Evaluation of the component position and kinematics after navigated and conventional Total Knee Arthroplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable

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

January 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
Last Updated

December 18, 2009

Status Verified

December 1, 2009

Enrollment Period

1.2 years

First QC Date

November 30, 2009

Last Update Submit

December 17, 2009

Conditions

Osteoarthritis of the Knee

Keywords

Total Knee ArthroplastyNavigation

Outcome Measures

Primary Outcomes (1)

  • rotational component position

    postoperatively

Secondary Outcomes (3)

  • leg axis

    postoperatively

  • kinematics

    postoperatively

  • clinical outcome

    18 to 24 month postoperatively

Study Arms (2)

navigated TKA

ACTIVE COMPARATOR
Procedure: Implantation of a Total Knee Arthroplasty

conventional TKA

OTHER
Procedure: Implantation of a Total Knee Arthroplasty

Interventions

Implantation of a Total Knee ArthroplastyPROCEDURE

In all patients a cemented, unconstrained, cruciate-retaining TKA with a rotating platform (ScorpioTM PCS, Stryker Orthopaedics, Mahwah, NJ) was implanted. No patellar resurfacing was performed. A medial parapatellar approach with a femur-first preparation was done in all cases. The Stryker Navigation System, Knee Navigation Software V3.1 (Stryker Orthopaedics, Mahwah, NJ) was used for computer-assisted implantation. The conventional implantation was performed with femoral intramedullary and tibial extramedullary standard alignment guides.

Also known as: ScorpioTM PCS, Stryker Navigation System, Stryker Knee Navigation Software V3.1
conventional TKAnavigated TKA

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary or secondary osteoarthritis of the knee
  • indication to TKA
  • a mechanical axis between 20° varus and 5° valgus
  • signed informed consent

You may not qualify if:

  • previous hemi- or total arthroplasty
  • severe instability that could not be treated with an unconstrained, cruciate-retaining TKA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Dresden, Orthopaedic Department

Dresden, 01307, Germany

Location

Related Publications (4)

  • Lutzner J, Krummenauer F, Wolf C, Gunther KP, Kirschner S. Computer-assisted and conventional total knee replacement: a comparative, prospective, randomised study with radiological and CT evaluation. J Bone Joint Surg Br. 2008 Aug;90(8):1039-44. doi: 10.1302/0301-620X.90B8.20553.

    PMID: 18669959RESULT

  • Beyer F, Pape A, Lutzner C, Kirschner S, Lutzner J. Similar outcomes in computer-assisted and conventional total knee arthroplasty: ten-year results of a prospective randomized study. BMC Musculoskelet Disord. 2021 Aug 18;22(1):707. doi: 10.1186/s12891-021-04556-3.

    PMID: 34407776DERIVED

  • Harman MK, Banks SA, Kirschner S, Lutzner J. Prosthesis alignment affects axial rotation motion after total knee replacement: a prospective in vivo study combining computed tomography and fluoroscopic evaluations. BMC Musculoskelet Disord. 2012 Oct 23;13:206. doi: 10.1186/1471-2474-13-206.

    PMID: 23088451DERIVED

  • Lutzner J, Krummenauer F, Gunther KP, Kirschner S. Rotational alignment of the tibial component in total knee arthroplasty is better at the medial third of tibial tuberosity than at the medial border. BMC Musculoskelet Disord. 2010 Mar 25;11:57. doi: 10.1186/1471-2474-11-57.

    PMID: 20338042DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Klaus-Peter Günther, MD, PhD

    Orthopaedic Department, University Hospital Dresden

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 30, 2009

First Posted

December 1, 2009

Study Start

January 1, 2006

Primary Completion

April 1, 2007

Study Completion

December 1, 2008

Last Updated

December 18, 2009

Record last verified: 2009-12

Locations

DE(1)