Femur FracturesNCT01354535
Types of Fixation of Vancouver B1 Periprosthetic Fractures
A study testing Isolated Locked Compression Plate and Cable Plating and Strut Allograft with Cerclage Wiring in people with Femur Fractures, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to compare two different but standard treatments for the fixation of Vancouver B1 periprosthetic. The investigators aim to compare open reduction internal fixation using a locked plating system versus plating and strut allograft with cerclage wiring to determine which treatment results in… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Femur Fractures
- What is being tested?
- Isolated Locked Compression Plate and Cable Plating and Strut Allograft with Cerclage Wiring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2013to Jun 2023
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: over 18, no upper limit
- Vancouver type B1 periprosthetic fracture
- Fracture is amenable to either treatment group
- Prosthesis is well fixed
- Provision of informed consent
Who cannot join
- Presence of an active infection around the fracture (soft tissue or bone)
- Loose prosthesis
- Trauma patients with an ISS > 16 or associated major injuries of the lower extremities
- Known substance abuse
- Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e., patients with no fixed address, report a plan to move out of town, or intellectually challenged patients without adequate family support)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. michael's Hospital
Toronto, Ontario, M5C 1R1
Milena Vicente, RN, CCRP, 416-864-6060 ext. 2608, vicentem@smh.ca
Emil Schemitsch, MD, FRCS(C)
About this study
Official title: Isolated Locked Compression Plating Versus Cable Plating and Strut Allografts With Cerclage Wiring for Vancouver B1 Periprosthetic Femoral Fractures: A Randomized Controlled Trial
The purpose of this study is to compare two different but standard treatments for the fixation of Vancouver B1 periprosthetic. The investigators aim to compare open reduction internal fixation using a locked plating system versus plating and strut allograft with cerclage wiring to determine which treatment results in a faster return to function as measured by the TUG test at 6 weeks post-op.
- Conditions
- Femur Fractures
- Being tested
- Isolated Locked Compression Plate, Cable Plating and Strut Allograft with Cerclage Wiring
- Keywords
- periprosthetic, femur fractures, Vancouver B1
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolated Locked Compression PlateProcedure or surgery
A lateral thigh incision will be used to expose the fracture site. Surgeons will attempt to minimize devascularization of the bone by meticulous dissection and indirect reduction techniques. An appropriate sized plate will be applied to the lateral aspect of the femur. Fracture reduction will be achieved with the use of intra-operative fluoroscopy and the plate will be secured with locking screws.
Cable Plating and Strut Allograft with Cerclage WiringProcedure or surgery
The plate will be placed laterally with the allograft strut placed on the anterior cortex. Screw fixation will be used distal to the stem and cables and screws will be used proximal to the stem tip. Cerclage cables or wires will be used to secure the strut.
| Study group | Role | What they receive |
|---|---|---|
| Cable plating with strut | Active comparator | The plate will be placed laterally with the allograft strut placed on the anterior cortex. Screw fixation will be used distal to the stem and cables and screws will be used proximal to the stem tip. Cerclage cables or wires will be used to secure the strut. Receives: Procedure: Cable Plating and Strut Allograft with Cerclage Wiring |
| isolated plating | Active comparator | A lateral thigh incision will be used to expose the fracture site. Surgeons will attempt to minimize devascularization of the bone by meticulous dissection and indirect reduction techniques. An appropriate sized plate will be applied to the lateral aspect of the femur. Fracture reduction will be achieved with the use of intra-operative fluoroscopy and the plate will be secured with locking screws. Receives: Procedure: Isolated Locked Compression Plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
TUG test score at 6 weeks post-op
We will administer the TUG test to each patient at 6 weeks to determine if there is a difference in functional status between both groups.
Measured: 6 weeks
Secondary outcomes (1)
Re-operation rates
We will measure rates of re-operationin each of the treatment groups on study specific case report forms.
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 posted17 May 2011 (estimated)
- Study startFeb 2013
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femur FracturesStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emil Schemitsch, MD, FRCS(C), Principal investigator, Unity Health TorontoAaron Nauth, MD, FRCSC, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354535
- Sponsor's protocol ID
- 13052011
- Status last verified
- Jun 2021
- First submitted
- 13 May 2011
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolated Locked Compression Plating Versus Cable Plating and Strut Allografts With Cerclage Wiring for Vancouver B1 Periprosthetic Femoral Fractures: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01354535
- Acronym / sponsor ID
- 13052011
- Conditions
- Femur Fractures
- Keywords
- periprosthetic, femur fractures, Vancouver B1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 89 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 17 May 2011 (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.
The purpose of this study is to compare two different but standard treatments for the fixation of Vancouver B1 periprosthetic. The investigators aim to compare open reduction internal fixation using a locked plating system versus plating and strut allograft with cerclage wiring to determine which treatment results in a faster return to function as measured by the TUG test at 6 weeks post-op.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cable plating with strut | Active comparator | Procedure: Cable Plating and Strut Allograft with Cerclage WiringThe plate will be placed laterally with the allograft strut placed on the anterior cortex. Screw fixation will be used distal to the stem and cables and screws will be used proximal to the stem tip. Cerclage cables or wires will be used to secure the strut. |
| isolated plating | Active comparator | Procedure: Isolated Locked Compression PlateA lateral thigh incision will be used to expose the fracture site. Surgeons will attempt to minimize devascularization of the bone by meticulous dissection and indirect reduction techniques. An appropriate sized plate will be applied to the lateral aspect of the femur. Fracture reduction will be achieved with the use of intra-operative fluoroscopy and the plate will be secured with locking screws. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: over 18, no upper limit
- Vancouver type B1 periprosthetic fracture
- Fracture is amenable to either treatment group
- Prosthesis is well fixed
- Provision of informed consent
Key exclusion criteria (5 listed)
- Presence of an active infection around the fracture (soft tissue or bone)
- Loose prosthesis
- Trauma patients with an ISS > 16 or associated major injuries of the lower extremities
- Known substance abuse
- Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e., patients with no fixed address, report a plan to move out of town, or intellectually challenged patients without adequate family support)
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 |
|---|---|---|
| Isolated Locked Compression PlateA lateral thigh incision will be used to expose the fracture site. Surgeons will attempt to minimize devascularization of the bone by meticulous dissection and indirect reduction techniques. An appropriate sized plate will be applied to the lateral aspect of the femur. Fracture reduction will be achieved with the use of intra-operative fluoroscopy and the plate will be secured with locking screws. | Procedure or surgery | isolated plating |
| Cable Plating and Strut Allograft with Cerclage WiringThe plate will be placed laterally with the allograft strut placed on the anterior cortex. Screw fixation will be used distal to the stem and cables and screws will be used proximal to the stem tip. Cerclage cables or wires will be used to secure the strut. | Procedure or surgery | Cable plating with strut |
Primary outcome
TUG test score at 6 weeks post-op
Time frame: 6 weeks
We will administer the TUG test to each patient at 6 weeks to determine if there is a difference in functional status between both groups.
1 secondary outcome
Re-operation rates
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
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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.
Emil Schemitsch, MD, FRCS(C) principal investigator
Unity Health Toronto
Aaron Nauth, MD, FRCSC principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isolated Locked Compression Plate and Cable Plating and Strut Allograft with Cerclage Wiring in people with Femur Fractures, run by Unity Health Toronto 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Jun 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emil Schemitsch, MD, FRCS(C) (416-864-6003, schemitsche@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TUG test score at 6 weeks post-op (time frame: 6 weeks). 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 18 Jun 2021.