Accuracy of MRI-based Patients Matched Instruments vs Jig-based Instruments in Total Knee Arthroplasty (TKA)

Accuracy of MRI-based Patients Matched Instruments and Jig-based Instruments in Total Knee Arthroplasty

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01449474

Enrollment

Registered

2011-10-10

Start date

2011-04-30

Completion date

2011-10-31

Last updated

2013-02-22

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

Conditions

Osteoarthritis of Knee

Brief summary

Total knee arthroplasty (TKA) is the common and effective procedure for treatment of end-staged knee osteoarthritis. Postoperative alignment of TKA is one of the important factors which effects on survival of prosthesis. High percentage of misalignment has been reported in conventional technique with using the jig based instruments. Several methods and devices were established to solve this problem. Customized or patient matched instruments were the novel technology that made from magnetic resonance imaging (MRI) of lower limb. With using special software to calculate the alignment axis, it was thought that accurate alignment can be achieved by using this instruments. Therefore, the study aimed to compare the accuracy of MRI based patient matched instruments and jig based instruments in TKA.

Interventions

DEVICEPatient matched instruments

The patients undergo TKA with using patient matched instruments

DEVICEJig based instruments

The patients undergo TKA with using jig based instruments

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Patients diagnosed primary osteoarthritis of knee and planned to undergo total knee arthroplasty

Exclusion criteria

* Previous complex surgery of the affected knee * Metalic implant in the affected lower limb * Patients who unable or contraindicated to perform MRI * Extra-articular deformities of the affected lower limb * Extensive bone loss of distal femur or/and proximal tibia * More than 30 degrees of knee flexion contracture * Unable to perform TKA within 12 weeks after MRI

Design outcomes

Primary

Measure	Time frame
The alignment of mechanical axis after TKA	Within 1 month after operation

Secondary

Measure	Time frame
The alignment of femoral and tibial components after TKA	Within 1 month after operation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026