Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01772589

Enrollment

Registered

2013-01-21

Start date

2015-02-28

Completion date

2015-02-28

Last updated

2018-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

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.

Interventions

PROCEDURENew saw blade

PROCEDUREReprocessed saw blade

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Implant migration	2 years	Implant migration assessed with RSA

Secondary

Measure	Time frame	Description
Economics	1 year	Cost comparison of saw blades

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026