Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration

G

Glen Richardson

Status

Withdrawn

Conditions

Osteoarthritis

Treatments

Procedure: Reprocessed saw blade
Procedure: New saw blade

Study type

Interventional

Funder types

Other

Identifiers

NCT01772589
SAW BLD

Details and patient eligibility

About

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.

Sex

All

Ages

21 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Symptomatic osteoarthritis of the knee indicating surgical intervention
  • Between the ages of 21 and 80 inclusive
  • Ability to give informed consent

Exclusion criteria

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

0 participants in 2 patient groups

New saw blade
Active Comparator group
Description:
New saw blade
Treatment:
Procedure: New saw blade
Reprocessed saw blade
Active Comparator group
Description:
Reprocessed saw blade
Treatment:
Procedure: Reprocessed saw blade

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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