Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration

Glen Richardson

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Conditions

Osteoarthritis

Interventions

New saw bladePROCEDURE

Reprocessed saw bladePROCEDURE

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Capital District Health Authority

Halifax, Nova Scotia, Canada

Outcomes

Primary Outcomes

Implant migration

Implant migration assessed with RSA

Time frame: 2 years

Secondary Outcomes

Economics

Cost comparison of saw blades

Time frame: 1 year

Data from ClinicalTrials.gov

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