Periprosthetic FracturesNCT01973712
Periprosthetic Distal Femur Fracture
A study testing Locked Compression Plating and Retrograde Intramedullary Nailing (RIMN) in people with Periprosthetic Fractures and Distal Femur Fractures, run by Unity Health Toronto at 1 site in Canada.
Trial summary
A periprosthetic distal femur fracture is a fracture close to a knee implant. This type of fracture is often difficult to fix because of the close proximity of the two surgical implants which can sometimes interfere with proper bone healing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periprosthetic Fractures, Distal Femur Fractures
- What is being tested?
- Locked Compression Plating and Retrograde Intramedullary Nailing (RIMN)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to Jan 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and older Displaced periprosthetic fracture of the distal femur Fracture amenable to both treatment groups, in the opinion of the investigator Knee prosthesis is well-fixed and non-stemmed Open box femoral component Provision of written informed consent
Who cannot join
- Presence of an active infection around the fracture (soft tissue or bone) Open fracture Injury Severity Score (ISS) > 15 or any associated major injuries of the lower extremities Medical contraindication to surgery Pregnant women Likely problems, in the judgment of the investigators, with maintaining follow-up
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital, Department of Orthopaedic Surgery
Toronto, Ontario, M5C 1R6
Milena Vicente, RN, CCRP, 416-864-6060 ext. 2608, vicentem@smh.ca
Emil Schemitsch, MD, FRCAC
About this study
Official title: Treatment of Periprosthetic Distal Femur Fractures: A Randomized Controlled Trial of Locking Plate Osteosynthesis Versus Retrograde Nailing
A periprosthetic distal femur fracture is a fracture close to a knee implant. This type of fracture is often difficult to fix because of the close proximity of the two surgical implants which can sometimes interfere with proper bone healing. Improper healing can cause significant impairment and sometimes requires additional surgeries to correct the problem. Despite considerable interest and research put into developing techniques to repair this fracture surgeons do not know which is the best way to treat this type of fracture.
Our multicentre orthopaedic study group is conducting this study to compare two standard, but different treatments for periprosthetic distal femur fractures. One treatment consists of open surgery and the placement of a plate and screws along the side of the femur. The other consists of implanting an intramedullary nail in the femur.
The goal of this study is to directly compare the two treatments to see if one treatment results in better patient outcomes than the other.
- Conditions
- Periprosthetic Fractures, Distal Femur Fractures
- Being tested
- Locked Compression Plating, Retrograde Intramedullary Nailing (RIMN)
- Medical subject headings
- Periprosthetic Fractures, Femoral Fractures, Distal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locked Compression PlatingProcedure or surgery
Retrograde Intramedullary Nailing (RIMN)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Locked Compression Plating | Experimental | A direct lateral approach to the distal femur will be employed utilizing minimally invasive and indirect reduction techniques. After fracture reduction is achieved with the use of intra-operative fluoroscopy, a locking plate will be provisionally implanted. Following confirmation of placement, definitive fixation will follow with multiple locking screws in the distal fragment and bicortical screw fixation proximally. A standard layered closure will follow Receives: Procedure: Locked Compression Plating |
| Retrograde Intramedullary Nailing (RIMN) | Experimental | The previous midline knee incision will be employed to access to the knee joint, allowing exposure of the femoral start point via the open box in the femoral component. Following reaming of the canal, an appropriately sized retrograde nail will be inserted. Intra-operative fluoroscopy will be used to confirm reduction. Both proximal and distal locking screws will be used to transfix the nail. A standard layered closure will follow. Receives: Procedure: Retrograde Intramedullary Nailing (RIMN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go (TUG) test
The TUG is a very simple timed test that was introduced in 1991 to measure mobility in the elderly. It involves documenting the time, in seconds, taken for subjects to rise from a standard arm chair, walk to a line on the floor 3 meters away, turn, return, and sit down again
Measured: 3 months
Secondary outcomes (1)
Rates of re-operation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startMay 2014
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periprosthetic 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron Nauth, MD, FRCSC, Principal investigator, Unity Health TorontoEmil Schemitsch, MD, FRCSC, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973712
- Sponsor's protocol ID
- PPDF
- Status last verified
- Jun 2021
- First submitted
- 25 Oct 2013
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Claireaux HA, Searle HKC, Parsons NR, Griffin XL. Interventions for treating fractures of the distal femur in adults. Cochrane Database Syst Rev. 2022 Oct 5;10(10):CD010606. doi: 10.1002/14651858.CD010606.pub3.
PubMed 36197809
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
- Treatment of Periprosthetic Distal Femur Fractures: A Randomized Controlled Trial of Locking Plate Osteosynthesis Versus Retrograde Nailing
- ClinicalTrials.gov ID
- NCT01973712
- Acronym / sponsor ID
- PPDF
- Conditions
- Periprosthetic Fractures, Distal Femur Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 31 Oct 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.
A periprosthetic distal femur fracture is a fracture close to a knee implant. This type of fracture is often difficult to fix because of the close proximity of the two surgical implants which can sometimes interfere with proper bone healing. Improper healing can cause significant impairment and sometimes requires additional surgeries to correct the problem. Despite considerable interest and research put into developing techniques to repair this fracture surgeons do not know which is the best way to treat this type of fracture.
Our multicentre orthopaedic study group is conducting this study to compare two standard, but different treatments for periprosthetic distal femur fractures. One treatment consists of open surgery and the placement of a plate and screws along the side of the femur. The other consists of implanting an intramedullary nail in the femur.
The goal of this study is to directly compare the two treatments to see if one treatment results in better patient outcomes than the other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Locked Compression Plating | Experimental | Procedure: Locked Compression PlatingA direct lateral approach to the distal femur will be employed utilizing minimally invasive and indirect reduction techniques. After fracture reduction is achieved with the use of intra-operative fluoroscopy, a locking plate will be provisionally implanted. Following confirmation of placement, definitive fixation will follow with multiple locking screws in the distal fragment and bicortical screw fixation proximally. A standard layered closure will follow |
| Retrograde Intramedullary Nailing (RIMN) | Experimental | Procedure: Retrograde Intramedullary Nailing (RIMN)The previous midline knee incision will be employed to access to the knee joint, allowing exposure of the femoral start point via the open box in the femoral component. Following reaming of the canal, an appropriately sized retrograde nail will be inserted. Intra-operative fluoroscopy will be used to confirm reduction. Both proximal and distal locking screws will be used to transfix the nail. A standard layered closure will follow. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 years and older Displaced periprosthetic fracture of the distal femur Fracture amenable to both treatment groups, in the opinion of the investigator Knee prosthesis is well-fixed and non-stemmed Open box femoral component Provision of written informed consent
Key exclusion criteria (1 listed)
- Presence of an active infection around the fracture (soft tissue or bone) Open fracture Injury Severity Score (ISS) > 15 or any associated major injuries of the lower extremities Medical contraindication to surgery Pregnant women Likely problems, in the judgment of the investigators, with maintaining follow-up
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 |
|---|---|---|
| Locked Compression Plating | Procedure or surgery | Locked Compression Plating |
| Retrograde Intramedullary Nailing (RIMN) | Procedure or surgery | Retrograde Intramedullary Nailing (RIMN) |
Primary outcome
Timed Up and Go (TUG) test
Time frame: 3 months
The TUG is a very simple timed test that was introduced in 1991 to measure mobility in the elderly. It involves documenting the time, in seconds, taken for subjects to rise from a standard arm chair, walk to a line on the floor 3 meters away, turn, return, and sit down again
1 secondary outcome
Rates of re-operation
Time frame: 12 months
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.
- Derived from this study: PubMed 36197809Claireaux HA, Searle HKC, Parsons NR, Griffin XL. Interventions for treating fractures of the distal femur in adults. Cochrane Database Syst Rev. 2022 Oct 5;10(10):CD010606. doi: 10.1002/14651858.CD010606.pub3.
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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.
Aaron Nauth, MD, FRCSC principal investigator
Unity Health Toronto
Emil Schemitsch, 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 Locked Compression Plating and Retrograde Intramedullary Nailing (RIMN) in people with Periprosthetic Fractures and Distal 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 1 inclusion and 1 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 Milena Vicente, RN, CCRP (416-864-6060 ext. 2608, vicentem@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (TUG) test (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01973712, which also lists 1 linked publication.
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.