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

Phase 4

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Procedure: Standard knee cutting guides; Procedure: Patient specific cutting guides

• Registration Number: NCT02128464
• Lead Sponsor: Thammasat University

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-11-25
• Study First Submitted QC: 2014-04-29
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Study First Posted: 2014-05-01
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-28
• Last Update Posted: 2016-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard knee cutting guides	Standard knee cutting guides	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.
Patient specific cutting guides	Patient specific cutting guides	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.

Primary Outcome Measures

Name	Time	Method
Mechanical Axis Alignment (Absolute Value Measured in Degrees) Using 3 Feet Long Leg Films	3 Months Post-operative	Femoral Valgus Angle, Tibial varus angle, Tibial slope, Femoral Flexsion/Extension angle, Implant Rotation

Secondary Outcome Measures

Name	Time	Method
Blood volume in suction drain	Post-operative Day 2
Operative time	During the procedure
Hemoglobin level	Post-operative day1, 2, 3
WOMAC score	1 year
Intraoperative Bleeding	Intra-operative

Trial Locations

Locations (1)

Thammasat University Hospital.; 🇹🇭 Pathumthani, Thailand