Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration

Not Applicable

Withdrawn

• Conditions: Osteoarthritis
• Interventions: Procedure: New saw blade; Procedure: Reprocessed saw blade

• Registration Number: NCT01772589
• Lead Sponsor: Glen Richardson

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-17
• Study First Submitted QC: 2013-01-18
• Study First Posted: 2013-01-21
• Study Start: 2015-02
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-05
• Last Update Posted: 2018-02-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New saw blade	New saw blade	New saw blade
Reprocessed saw blade	Reprocessed saw blade	Reprocessed saw blade

Primary Outcome Measures

Name	Time	Method
Implant migration	2 years	Implant migration assessed with RSA

Secondary Outcome Measures

Name	Time	Method
Economics	1 year	Cost comparison of saw blades

Trial Locations

Locations (1)

Capital District Health Authority; 🇨🇦 Halifax, Nova Scotia, Canada