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

NCT02128464 | Completed Phase 4 DMC

• 1 other identifier: OrthoTu-02
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Total Knee Arthroplasty; Customized Cutting Block; Conventional Intramedullary Cutting Guide

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Intraoperative Bleeding

  Intra-operative

• Operative time

  During the procedure

• Blood volume in suction drain

  Post-operative Day 2

• Hemoglobin level

  Post-operative day1, 2, 3

• WOMAC score

  6 weeks

Other Outcomes (1)

• WOMAC Score

  2 years

Study Arms (2)

Standard knee cutting guides

ACTIVE COMPARATOR

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.

Procedure: Standard knee cutting guides

Patient specific cutting guides

ACTIVE COMPARATOR

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.

Procedure: Patient specific cutting guides

Interventions

Patient specific cutting guides PROCEDURE

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.

Patient specific cutting guides

Standard knee cutting guides PROCEDURE

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.

Standard knee cutting guides

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Thammasat University: lead

Study Sites (1)

Thammasat University Hospital.

Pathum Thani, Changwat Pathum Thani, 12120, Thailand

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Phonthakorn Panichkul, MD

  Thammasat University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phonthakorn Panichkul

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: May 1, 2014
• Study Start: October 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 29, 2016

Record last verified: 2016-07

Locations

TH (1)