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Completed

NCT Number: NCT02128464

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

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

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Thammasat University Hospital.

Pathum Thani, Changwat Pathum Thani, 12120, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 3 Months Post-operative

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

Secondary outcomes

  1. Intraoperative Bleeding

    Time frame: Intra-operative

  2. Operative time

    Time frame: During the procedure

  3. Blood volume in suction drain

    Time frame: Post-operative Day 2

  4. Hemoglobin level

    Time frame: Post-operative day1, 2, 3

  5. WOMAC score

    Time frame: 6 weeks

  6. WOMAC score

    Time frame: 3 Months

  7. WOMAC score

    Time frame: 6 Months

  8. WOMAC score

    Time frame: 1 year

Other outcomes

  1. WOMAC Score

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 1, 2014
Registry last updated
Jul 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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