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

Thammasat University108 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

108

Conditions

Knee Osteoarthritis

Interventions

Patient specific cutting guidesPROCEDURE

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.

Standard knee cutting guidesPROCEDURE

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.

Eligibility

Sex: ALLMin age: 60 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Thammasat University Hospital.

Pathum Thani, Changwat Pathum Thani, Thailand

Outcomes

Primary Outcomes

Mechanical Axis Alignment (Absolute Value Measured in Degrees) Using 3 Feet Long Leg Films

Femoral Valgus Angle, Tibial varus angle, Tibial slope, Femoral Flexsion/Extension angle, Implant Rotation

Time frame: 3 Months Post-operative

Secondary Outcomes

Intraoperative Bleeding

Time frame: Intra-operative

Operative time

Time frame: During the procedure

Blood volume in suction drain

Time frame: Post-operative Day 2

Hemoglobin level

Time frame: Post-operative day1, 2, 3

WOMAC score

Time frame: 6 weeks

WOMAC score

Time frame: 3 Months

WOMAC score

Time frame: 6 Months

WOMAC score

Time frame: 1 year

Data from ClinicalTrials.gov

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