Signature* Personalized Patient Care in Total Knee Arthroplasty;Comparing preoperatively planned alignment with postoperative achieved alignment;A prospective shape-matching study

Signature* Personalized Patient Care in Total Knee Arthroplasty;Comparing preoperatively planned alignment with postoperative achieved alignment;A prospective shape-matching study - Grating postoperative alignment TKA

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36146

Enrollment

Registered

2011-03-28

Start date

2011-06-28

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

gonarthrosis knee wear

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients scheduled to undergo primary total knee replacement with any of the following indications Painful and disabled knee joint resulting from osteoarthritis. One or more compartments are involved, as assessed by X-ray. High need to obtain pain relief and improve function, Above 18 years old (full skeletal maturity) 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 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 and CT-scan

Design outcomes

Primary

Measure	Time frame
To compare the preoperatively planned, computer-based Signature* alignment plan with the actual achieved alignment in the frontal, coronal and sagittal plane in vivo postoperatively of both the femur and tibia components of the total knee arthroplasty.	—

Secondary

Measure	Time frame
To determine the occurrence (and percentage) of outliers in alignment in the frontal, sagittal and horizontal plane of femoral and tibial components. To determine the occurrence (and percentage) of outliers in alignment of the mechanical axis of the leg. Verify the fit, form and practical use of the Signature* alignment guides. Verify to what extend the thickness of the in vivo inserted polyethylene corresponds with the pre-operatively calculated thickness of this insert.	—

Measure

Time frame

To determine the occurrence (and percentage) of outliers in alignment in the frontal, sagittal and horizontal plane of femoral and tibial components. To determine the occurrence (and percentage) of outliers in alignment of the mechanical axis of the leg. Verify the fit, form and practical use of the Signature* alignment guides. Verify to what extend the thickness of the in vivo inserted polyethylene corresponds with the pre-operatively calculated thickness of this insert.

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Countries

Netherlands

Outcome results