Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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New saw blade

Group Type ACTIVE_COMPARATOR

New saw blade

Intervention Type PROCEDURE

Reprocessed saw blade

Group Type ACTIVE_COMPARATOR

Reprocessed saw blade

Intervention Type PROCEDURE

Interventions

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New saw blade

Intervention Type PROCEDURE

Reprocessed saw blade

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No