Comparison of the Femoral Prothesis-rotation in Conventional X-ray, in Axial CT Slices and 3D-reconstructed CT

NCT02261038 | Completed DMC

• 2 other identifiers: Rad-2CT-3CT_001_MH332/13
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Femoral component rotation in total knee arthroplasty (TKA) has been considered an important factor for outcome. However, measurement of femoral component rotation is difficult to perform. Femoral TKA component rotation can be assessed on special radiographs (Kanekasu technique), axial CT slices and 3D reconstructed CT images. It was the hypothesis that measurements on radiographs are comparable to measurement on CT images. Measurements of femoral TKA rotation will be measured three times by three different observers and inter- and intraobserver reliability is calculated. The absolute values of each measurement method is noted in degrees.

Conditions

Osteoarthritis

Keywords

total knee arthroplasty; total knee prothesis; X-Ray; Kanekasu radiographs; femoral component rotation; effects

Outcome Measures

Primary Outcomes (1)

• Femoral TKA component rotation in degrees

  Femoral TKA component rotation in degrees is assessed on radiographs (Kanekasu), axial CT and 3D reconstructed CT images. All three measurement by each three observers are compared to each other.

  one year

Secondary Outcomes (1)

• Inter- and intraobserver reliability of TKA femoral component rotation

  one year

Study Arms (1)

Kanekasu radiographs

OTHER

No drugs or devices are used in this study. Commonly available radiological techniques such as radiographs and CT are used. All patients undergo a CT of the knee and a special radiograph (Kanekasu technique).

Other: Kanekasu radiographs

Interventions

Kanekasu radiographs OTHER

No interventions are performed here. All patients undergo CT and special radiographs of the knee to assess femoral TKA rotation.

Also known as: Femoral component rotation, total knee prothesis, X-ray, kanekasu-technic

Kanekasu radiographs

Eligibility Criteria

• Age: 55 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Total Knee prosthesis (primary)
• \>55 years

You may not qualify if:

• pregnancy
• lactating women

Sponsors & Collaborators

• Michael Tobias Hirschmann: lead

Study Sites (1)

Kantonsspital Baselland, Bruderholz

Bruderholz, Basel-Landschaft, 4101, Switzerland

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Michael T. Hirschmann, MD

  Dept. of Orthop. Surgery and Traumatology, Kantonsspital Baselland - Bruderholz, Unitverstity of Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: October 10, 2014
• Study Start: November 1, 2014
• Primary Completion: February 1, 2018
• Study Completion: February 28, 2018
• Last Updated: October 24, 2018

Record last verified: 2018-10

Locations

CH (1)