Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration

February 5, 2018 updated by: Glen Richardson

Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration. A Randomized Controlled Study With Radiostereometric Analysis

There have been considerable efforts to control rising health care costs. One of the more recent developments is the practice of reprocessing single use medical devices. This practice has been shown to provide considerable savings for health care payers. Medical devices have been reprocessed in a number of different medical fields including Orthopaedic Surgery. One of the devices that has been reprocessed are the Precision Saw Blades from Stryker Inc. These saw blades are used during Total Knee Arthroplasty (TKA) surgery. The reprocessed Precision saw blades are Health Canada approved and are available at Capital Health.

Beyond the benefits to the environment and cost savings, the investigators do not know if the reprocessed saw blades work better, work worse or the same as non reprocessed saw blades. This study is designed to determine if the reprocessed saw blades used during a TKA work as well as a new saw blade.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Capital District Health Authority

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Symptomatic osteoarthritis of the knee indicating surgical intervention
  2. Between the ages of 21 and 80 inclusive
  3. Ability to give informed consent

Exclusion Criteria:

  1. Significant co-morbidity affecting ability to ambulate
  2. Flexion contracture greater than 15°
  3. Extension lag greater than 10°
  4. Tibial subluxation greater than 10 mm on standing AP radiograph
  5. Prior arthroplasty, patellectomy or osteotomy with the affected knee
  6. Lateral or medial collateral ligament instability (> 10° varus/valgus)
  7. Leg length discrepancy greater than 10 mm
  8. Bone quality precluding uncemented fixation
  9. Pregnancy
  10. Active or prior infection
  11. Morbid Obesity (BMI > 40)
  12. Medical condition precluding major surgery
  13. Severe osteoporosis or osteopenia
  14. Neuromuscular impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: New saw blade
Procedure: New saw blade
Active Comparator: Reprocessed saw blade
Procedure: Reprocessed saw blade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant migration
Time Frame: 2 years
Implant migration assessed with RSA
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Economics
Time Frame: 1 year
Cost comparison of saw blades
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glen Richardson

Investigators

  • Principal Investigator: Glen Richardson, MD, Capital Health, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

January 17, 2013

First Submitted That Met QC Criteria

January 18, 2013

First Posted (Estimate)

January 21, 2013

Study Record Updates

Last Update Posted (Actual)

February 6, 2018

Last Update Submitted That Met QC Criteria

February 5, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAW BLD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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