Clinical trial NCT01022099: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of the Knee
Keywords: Total Knee Arthroplasty
Navigation
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2009-12-01
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 1. 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.
2. 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.

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

Primary outcomes:
measure: rotational component position
timeFrame: postoperatively
Secondary outcomes:
measure: leg axis
timeFrame: postoperatively
measure: kinematics
timeFrame: postoperatively
measure: clinical outcome
timeFrame: 18 to 24 month postoperatively
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Hospital Dresden, Orthopaedic Department
Study officials:
affiliation: Orthopaedic Department, University Hospital Dresden
name: Klaus-Peter Günther, MD, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.