OsteoarthritisNCT01772589
Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration
A study testing New saw blade and Reprocessed saw blade in people with Osteoarthritis, run by Glen Richardson at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- New saw blade and Reprocessed saw blade
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2015to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic osteoarthritis of the knee indicating surgical intervention
- Between the ages of 21 and 80 inclusive
- Ability to give informed consent
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration. A Randomized Controlled Study With Radiostereometric Analysis
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.
- Conditions
- Osteoarthritis
- Being tested
- New saw blade, Reprocessed saw blade
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New saw bladeProcedure or surgery
Reprocessed saw bladeProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| New saw blade | Active comparator | New saw blade Receives: Procedure: New saw blade |
| Reprocessed saw blade | Active comparator | Reprocessed saw blade Receives: Procedure: Reprocessed saw blade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant migration
Implant migration assessed with RSA
Measured: 2 years
Secondary outcomes (1)
Economics
Cost comparison of saw blades
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startFeb 2015
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: Comparator sawblade no longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glen Richardson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Glen Richardson, Nova Scotia Health Authority
- Investigators
- Glen Richardson, MD, Principal investigator, Capital Health, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772589
- Sponsor's protocol ID
- SAW BLD
- Status last verified
- Feb 2018
- First submitted
- 17 Jan 2013
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration. A Randomized Controlled Study With Radiostereometric Analysis
- ClinicalTrials.gov ID
- NCT01772589
- Acronym / sponsor ID
- SAW BLD
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Comparator sawblade no longer available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Glen RichardsonUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 21 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New saw blade | Active comparator | Procedure: New saw bladeNew saw blade |
| Reprocessed saw blade | Active comparator | Procedure: Reprocessed saw bladeReprocessed saw blade |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic osteoarthritis of the knee indicating surgical intervention
- Between the ages of 21 and 80 inclusive
- Ability to give informed consent
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New saw blade | Procedure or surgery | New saw blade |
| Reprocessed saw blade | Procedure or surgery | Reprocessed saw blade |
Primary outcome
Implant migration
Time frame: 2 years
Implant migration assessed with RSA
1 secondary outcome
Economics
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glen Richardson, MD principal investigator
Capital Health, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New saw blade and Reprocessed saw blade in people with Osteoarthritis, run by Glen Richardson at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant migration (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2018.