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Clinical Trials/NCT01781598
NCT01781598
Completed
Not Applicable

Patient-specific Instruments as a Standard Procedure in Total Knee Arthroplasty: Logistics, Learning Curve, and Postoperative Radiological Results in 70 Patients

Orthopedic Clinic Gersthof1 site in 1 country73 target enrollmentSeptember 2011
ConditionsAlignment

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alignment
Sponsor
Orthopedic Clinic Gersthof
Enrollment
73
Locations
1
Primary Endpoint
Alignment
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

Description of logistics, learning curve and radiological results in 70 patients treated with patient specific instrumentation in total knee arthroplasty as a standard procedure

Detailed Description

The Orthopaedic Clinic Gersthof is a teaching hospital, where the entire spectrum of joint replacements with emphasis on hips and knees is performed. Twenty surgeons perform TKAs at our institution, with approximately 400 TKAs implanted per year. The PSI system of Smith \&Nephew® (Patient-Matched Cutting Blocks \[PMCB\]; the VISIONAIRE® technology) is applied. The preoperative image modality is based on a long leg standing X-ray as well as an MRI of the knee. The Genesis II® Endoprosthesis (Smith \& Nephew®) is used as the TKA implant. This study is a observational monocentric prospective study. Estimated enrollment: 70 Enrollment time: September 2011-October 2012 Primary outcome: Alignment The postoperative X-rays (AP, lateral view, and long leg standing), taken 7-to-10 days after surgery are evaluated in terms of component position and restoration of the mechanical alignment. X-rays are routinely monitor-guided but not calibrated at our institution. As a secondary outcome the learning curve is evaluated using the following parameters collected during surgery: the fit of the cutting blocks, changes of the implant size, bony recuts, soft tissue releases, and changes in inlay size. Gap balancing was subjectively judged by the operating surgeon. Operation time, number of blood transfusions, and early postoperative complications were recorded within the first 14 days after surgery.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
October 2012
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Orthopedic Clinic Gersthof
Responsible Party
Principal Investigator
Principal Investigator

Dominik Drnek

Dr. med. univ.

Orthopedic Clinic Gersthof

Eligibility Criteria

Inclusion Criteria

  • Indication for TKA
  • Genesis II endoprosthesis
  • Operated using patient specific instruments (VISIONAIRE)

Exclusion Criteria

  • contraindication for MRI
  • varus/ valgus deformity \>15 degrees

Outcomes

Primary Outcomes

Alignment

Time Frame: Postoperative x-ray (7-10 days after surgery)

Alignment measured on monitor-guided x-rays: Mechanical Alignment: Hip-Knee-Ankle angle in degrees \[°\] Alignment of the tibial and femoral component in the sagittal and coronal plane \[°\]

Secondary Outcomes

  • Learning curve(Intraoperative and early postoperative period (up to 14 days after surgery))

Study Sites (1)

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