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Prospective Randomized Trial of Navigated and Conventional TKA

Prospective Randomized Trial of Navigated and Conventional TKA With Radiographic and CT Evaluations

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01022099
Enrollment
80
Registered
2009-12-01
Start date
2006-01-31
Completion date
2008-12-31
Last updated
2009-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the Knee

Keywords

Total Knee Arthroplasty, Navigation

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.

Interventions

PROCEDUREImplantation of a Total Knee Arthroplasty

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.

Sponsors

Technische Universität Dresden
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
rotational component positionpostoperatively

Secondary

MeasureTime frame
leg axispostoperatively
kinematicspostoperatively
clinical outcome18 to 24 month postoperatively

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026