search
Back to results

Prospective Randomized Trial of Navigated and Conventional TKA

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Implantation of a Total Knee Arthroplasty
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Total Knee Arthroplasty, Navigation

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • University Hospital Dresden, Orthopaedic Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

navigated TKA

conventional TKA

Arm Description

Outcomes

Primary Outcome Measures

rotational component position

Secondary Outcome Measures

leg axis
kinematics
clinical outcome

Full Information

First Posted
November 30, 2009
Last Updated
December 17, 2009
Sponsor
Technische Universität Dresden
search

1. Study Identification

Unique Protocol Identification Number
NCT01022099
Brief Title
Prospective Randomized Trial of Navigated and Conventional TKA
Official Title
Prospective Randomized Trial of Navigated and Conventional TKA With Radiographic and CT Evaluations
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Technische Universität Dresden

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluation of the component position and kinematics after navigated and conventional Total Knee Arthroplasty.
Detailed Description
Component position, kinematics After skin closure lateral x-rays were done in different flexion angles in order to evaluate the kinematic behaviour of the TKA. A full-length standing and a lateral radiograph as well as CT scans of the hip, knee and ankle joint were performed 5 to 7 days postoperatively before discharge. clinical outcome Patient sociodemographic and anamnestic data were collected. The written interview was complemented by the EuroQol questionnaire (release EQ-5D) and the assessment of the patients' functional status (Knee Society Score) one week before surgery and 18 to 24 month after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
Total Knee Arthroplasty, Navigation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
navigated TKA
Arm Type
Active Comparator
Arm Title
conventional TKA
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Implantation of a Total Knee Arthroplasty
Other Intervention Name(s)
ScorpioTM PCS, Stryker Navigation System, Stryker Knee Navigation Software V3.1
Intervention Description
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.
Primary Outcome Measure Information:
Title
rotational component position
Time Frame
postoperatively
Secondary Outcome Measure Information:
Title
leg axis
Time Frame
postoperatively
Title
kinematics
Time Frame
postoperatively
Title
clinical outcome
Time Frame
18 to 24 month postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary or secondary osteoarthritis of the knee indication to TKA a mechanical axis between 20° varus and 5° valgus signed informed consent Exclusion Criteria: previous hemi- or total arthroplasty severe instability that could not be treated with an unconstrained, cruciate-retaining TKA
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus-Peter Günther, MD, PhD
Organizational Affiliation
Orthopaedic Department, University Hospital Dresden
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Dresden, Orthopaedic Department
City
Dresden
ZIP/Postal Code
01307
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
18669959
Citation
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.
Results Reference
result
PubMed Identifier
34407776
Citation
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.
Results Reference
derived
PubMed Identifier
23088451
Citation
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.
Results Reference
derived
PubMed Identifier
20338042
Citation
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.
Results Reference
derived

Learn more about this trial

Prospective Randomized Trial of Navigated and Conventional TKA

We'll reach out to this number within 24 hrs