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

Knee Osteoarthritis Clinical Trial

Official title:

Comparison of Customized Cutting Block (Visionaire™) and Conventional Total Knee Arthroplasty: A Prospective Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02128464
• Other study ID #: OrthoTu-02
• Secondary ID: OrthoTu-02
• Status: Completed
• Phase: Phase 4
• First received: November 25, 2013
• Last updated: July 28, 2016
• Start date: October 2012
• Est. completion date: May 2014

Study information

• Verified date: July 2016
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Thailand	Thammasat University Hospital.	Pathumthani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	WOMAC Score		2 years	No
Primary	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	3 Months Post-operative	No
Secondary	Intraoperative Bleeding		Intra-operative	No
Secondary	Operative time		During the procedure	No
Secondary	Blood volume in suction drain		Post-operative Day 2	No
Secondary	Hemoglobin level		Post-operative day1, 2, 3	No
Secondary	WOMAC score		6 weeks	No
Secondary	WOMAC score		3 Months	No
Secondary	WOMAC score		6 Months	No
Secondary	WOMAC score		1 year	No