Radiological evaluation of CT based vs MRI based Signature* for total knee arthroplasty

Radiological evaluation of CT based vs MRI based Signature* for total knee arthroplasty - CT vs MRI based Signature* for TKA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40504

Enrollment

140

Registered

2014-02-27

Start date

2014-04-08

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

knee wear osteoarthritis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Patients scheduled to undergo primary TKA replacement with any of the following indications *Painful and disabled knee joint resulting from osteoarthritis. *High need to obtain pain relief and improve function, -Body-mass-index (BMI)

Exclusion criteria

Exclusion criteria: -Active infection in knee -General infection -Distant foci of infections which may spread to the implant site -Failure of previous knee joint replacement -Pregnancy -Previous major knee surgery, except for arthroscopic meniscectomy. -Metal near knee joint (MRI-scan not possible) -Not able or willing to undergo MRI-scan or CT-scan -Reumatoid arthritis -Non-correctable varus axis

Design outcomes

Primary

Measure	Time frame
Outliers in alignment of the femoral and tibial prosthesis in the frontal plane, measured on radographs made 6 weeks after operation and compared between the CT-based Signature* procedure and the standard MRI-based Signature* Occurrence (and percentage) of outliers in alignment in the frontal, sagittal and horizontal plane of femoral and tibial components. Occurrence (and percentage) of outliers in alignment of the mechanical axis of the leg. Difference in thickness of the in vivo inserted polyethylene compared to pre-operatively calculated thickness of this insert. Accuracy of the guides	—

Measure

Time frame

Outliers in alignment of the femoral and tibial prosthesis in the frontal plane, measured on radographs made 6 weeks after operation and compared between the CT-based Signature* procedure and the standard MRI-based Signature* Occurrence (and percentage) of outliers in alignment in the frontal, sagittal and horizontal plane of femoral and tibial components. Occurrence (and percentage) of outliers in alignment of the mechanical axis of the leg. Difference in thickness of the in vivo inserted polyethylene compared to pre-operatively calculated thickness of this insert. Accuracy of the guides

—

Secondary

Measure	Time frame
Operation time Fit, form and practical use of the Signature* alignment guides. Needed change of plans per-operative: change of size of prosthesis, conversion Signature procedure to conventional procedure for any reason	—

Countries

Netherlands

Outcome results