Femoral FracturesPhase 4NCT00552331
Evaluation of the Effects of Less Invasive Stabilization System (LISS) Plating Techniques in Distal Femoral Fractures
A Phase 4 study testing Plates to treat fractures of the distal femur and LISS in people with Femoral Fractures, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether the rate of fracture healing and fracture union, repaired with the LISS device, will be as good as or better than the usual fracture fixation systems. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Femoral Fractures
- What is being tested?
- Plates to treat fractures of the distal femur and LISS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2003to Jul 2009
- Phase
- Phase 4
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patient has read and agree to the consent
- Patient is 16 years or older (bones have finished growing)
- The injury happened in the last 14 days
Who cannot join
- The patient taking part in another study
- The patient has an infection at the operative site
- The patient has a health condition that affects bone healing or interferes with their ability to complete the study requirements (questionnaires, examinations), for example Paget's disease or osteomalacia
- The patient is taking medication that affects bone healing (such as systemic steroids)
- The patient has malignant (tumor) disease
- The patient is unable to attend follow-up clinic visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Clinical Study to Evaluate the Effects of Less Invasive Stabilization System (LISS) Plating Techniques in Distal Femoral Fractures
The purpose of this study is to determine whether the rate of fracture healing and fracture union, repaired with the LISS device, will be as good as or better than the usual fracture fixation systems.
- Conditions
- Femoral Fractures
- Being tested
- Plates to treat fractures of the distal femur, LISS
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plates to treat fractures of the distal femurDevice
use of dynamic condylar screws or locking condylar plates in the treatment of distal femur fractures
LISSDevice
treatment of distal femur fractures with less invasive stabilization systems
| Study group | Role | What they receive |
|---|---|---|
| LISS | Active comparator | Treatment of distal femur fracture with less invasive stabilization system Receives: Device: LISS |
| Standard Treatment | Active comparator | Treatment of distal femoral fractures using locking condylar plates or dynamic condylar screws Receives: Device: Plates to treat fractures of the distal femur |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed union or nonunion of the distal femur
Determined via radiographic analysis
Measured: 12 months post operative
Secondary outcomes (5)
Time to clinical healing
assessed by weight-bearing ability and pain
Measured: 12 months
Function as assessed by patient
Assessed using LEM, SMFA, and SF-36 questionnaires
Measured: 6 months, 12 months
Frequency of adverse events
Measured: 12 months
Range of motion
Measured: Post-op, 6 weeks, 3 months, 6 months, 12 months
Gait analysis
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 posted1 Nov 2007 (estimated)
- Study startMar 2003
- Primary completionJul 2009
- Study completionJul 2009
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 Femoral FracturesStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Synthes Canada, AO Research Fund
- Investigators
- Ross K Leighton, MD, FRCS(C), Principal investigator, Capital Health, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552331
- Sponsor's protocol ID
- CDHA-RL-003
- Status last verified
- May 2009
- First submitted
- 30 Oct 2007
- Last updated
- 28 Jun 2011
- 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 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Study to Evaluate the Effects of Less Invasive Stabilization System (LISS) Plating Techniques in Distal Femoral Fractures
- ClinicalTrials.gov ID
- NCT00552331
- Acronym / sponsor ID
- CDHA-RL-003
- Conditions
- Femoral Fractures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Synthes Canada, AO Research Fund
- Study start
- Mar 2003
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 1 Nov 2007 (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 determine whether the rate of fracture healing and fracture union, repaired with the LISS device, will be as good as or better than the usual fracture fixation systems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LISS | Active comparator | Device: LISSTreatment of distal femur fracture with less invasive stabilization system |
| Standard Treatment | Active comparator | Device: Plates to treat fractures of the distal femurTreatment of distal femoral fractures using locking condylar plates or dynamic condylar screws |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- The patient has read and agree to the consent
- Patient is 16 years or older (bones have finished growing)
- The injury happened in the last 14 days
Key exclusion criteria (6 listed)
- The patient taking part in another study
- The patient has an infection at the operative site
- The patient has a health condition that affects bone healing or interferes with their ability to complete the study requirements (questionnaires, examinations), for example Paget's disease or osteomalacia
- The patient is taking medication that affects bone healing (such as systemic steroids)
- The patient has malignant (tumor) disease
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 |
|---|---|---|
| Plates to treat fractures of the distal femuruse of dynamic condylar screws or locking condylar plates in the treatment of distal femur fractures | Device | Standard Treatment |
| LISStreatment of distal femur fractures with less invasive stabilization systems | Device | LISS |
Primary outcome
Delayed union or nonunion of the distal femur
Time frame: 12 months post operative
Determined via radiographic analysis
5 secondary outcomes
Time to clinical healing
Time frame: 12 months
Function as assessed by patient
Time frame: 6 months, 12 months
Frequency of adverse events
Time frame: 12 months
Range of motion
Time frame: Post-op, 6 weeks, 3 months, 6 months, 12 months
Gait analysis
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
- 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.
Related trials for Femoral Fractures
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
Not yet recruiting
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
Tibial Fracture, Femoral Fracture
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
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.
Ross K Leighton, MD, FRCS(C) 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 Phase 4 study testing Plates to treat fractures of the distal femur and LISS in people with Femoral Fractures, run by Nova Scotia Health Authority 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 6 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: finished, as of the sponsor's last update on 28 Jun 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Delayed union or nonunion of the distal femur (time frame: 12 months post operative). 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 NCT00552331, 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 28 Jun 2011.