Outcome of TKA Using Customized Cutting Block Compared With Conventional Intramedullary Cutting Guide

Thammasat University

Status and phase: Completed; Phase 4

Conditions: Knee Osteoarthritis

Treatments: Procedure: Standard knee cutting guides; Procedure: Patient specific cutting guides

Study type: Interventional

Funder types: Other

Identifiers

NCT02128464

OrthoTu-02 (Other Identifier)

Details and patient eligibility

About

Customized cutting block and conventional cutting guide are both effective in improving accuracy and function of OA knee patients.

Full description

Customized cutting block and conventional cutting guide are both effective in improving accuracy and function of osteoarthritic knee patients.

Enrollment: 108 patients

Sex: All

Ages: 60 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 60-90
• Diagnosis of osteoarthritis or rheumatoid arthritis of the knee and qualify for surgery, as indicated by one of the following:
• Painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved;
• Correction of varus or valgus.
• Willing to participate and return for follow-up study visits.

Exclusion criteria

• Vascular insufficiency
• Previous deep vein thrombosis and pulmonary embolism
• Previous osteotomy
• Previous patella fracture or surgery
• Previous healed tibia or femur fractures
• Previous joint replacement surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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108 participants in 2 patient groups

Standard knee cutting guides

Active Comparator group

Description:

Standard cutting guides use traditional instrumentation to determine knee implant positions. During surgery, a rod is placed in the leg bone and the cutting guide is attached to that rod.

Treatment:

Procedure: Standard knee cutting guides

Patient specific cutting guides

Active Comparator group

Description:

Patient specific cutting guides are custom-made for each patient based on Magnetic Resonance Imaging (MRI). Before surgery, MRI of the knee is done and used to create a cutting guide that is formed to the exact shape of the knee. The patient specific cutting guides have platforms that can be attached to the bone, so the rod does not need to be placed in the leg bone.

Treatment:

Procedure: Patient specific cutting guides