Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01772589
• Other study ID #: SAW BLD
• Status: Withdrawn
• Phase: N/A
• First received: January 17, 2013
• Last updated: February 5, 2018
• Start date: February 2015
• Est. completion date: February 2015

Study information

• Verified date: February 2018
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• New saw blade

• Reprocessed saw blade

Locations

Country	Name	City	State
Canada	Capital District Health Authority	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Glen Richardson

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant migration	Implant migration assessed with RSA	2 years
Secondary	Economics	Cost comparison of saw blades	1 year