Closed Supracondylar Fracture of FemurWtBrFemFxNCT03167099
Immediate Weight Bearing Versus Protected Weight Bearing in Supracondylar Distal Femur Fractures
A study testing Full Weight Bearing in people with Closed Supracondylar Fracture of Femur, run by West Virginia University at 1 site in United States.
Trial summary
This study is designed to examine if immediate weight bearing on a distal femur fracture fixed with a primary locking plate, either a distal condylar locking plate or a LISS (less invasive stabilization system), is safe and promotes more rapid fracture healing than partial weight bearing, which is standard of care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Closed Supracondylar Fracture of Femur
- What is being tested?
- Full Weight Bearing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged > 18 yo
- distal supracondylar femur fracture (Supracondylar distal femur fractures treated with a locked plate, either a distal condylar locking plate or a LISS (less invasive stabilization system), including peri-prosthetic fractures)
- both male and female
Who cannot join
- Patients with an intracondylar split,
- polytrauma patients with associated trauma that will inhibit their ability to weight bear,
- metastatic disease,
- incomplete follow up,
- subjects with questionable ability to bear weight (ie advanced dementia),
- open fractures with bone loss.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University
Morgantown, West Virginia, 26506
About this study
Official title: Immediate Weight Bearing as Tolerated Versus Protected Weight Bearing in Supracondylar Distal Femur Fractures; a Prospective, Randomized Study
This study is designed to examine if immediate weight bearing on a distal femur fracture fixed with a primary locking plate, either a distal condylar locking plate or a LISS (less invasive stabilization system), is safe and promotes more rapid fracture healing than partial weight bearing, which is standard of care.
Read the detailed description
This study is designed to examine if immediate weight bearing on a distal femur fracture fixed with a primary locking plate, either a distal condylar locking plate or a LISS (less invasive stabilization system), is safe and promotes more rapid fracture healing than partial weight bearing, which is standard of care. Historically and currently patients are kept partial weight bearing after fixation of these fractures for 6-12 weeks until callous formation is observed on radiographs. The hypothesis is that participants allowed to bear weight immediately will heal at least as quickly as those who have weight bearing status protected with the added benefits from early mobilization. Fracture healing will be monitored closely by follow up appointments and complications will be documented.
- Conditions
- Closed Supracondylar Fracture of Femur
- Being tested
- Full Weight Bearing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full Weight BearingProcedure or surgery
full weight bearing after fixation of a distal femur fracture
| Study group | Role | What they receive |
|---|---|---|
| Full Weight Bearing | Experimental | Participants assigned to full weight bearing after fixation of distal femur fracture. Receives: Procedure: Full Weight Bearing |
| Partial Weight Bearing | No intervention | Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Distal Femur Fracture Healing by Radiographic Evidence
Radiographs were analyzed postoperatively to determine bridging of 3 or 4 cortices per standard of care during follow-up office visits.
Measured: up to 12 weeks
Secondary outcomes (2)
Time to Ambulation
Investigators measure time to ambulation
Measured: up to 24 weeks
Time of Participation in Physical Therapy
Investigators measure the length of time of physical therapy participation
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study startApr 2015
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Closed Supracondylar Fracture of FemurStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Hubbard, MD, West Virginia University
- Investigators
- David F Hubbard, MD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167099
- Sponsor's protocol ID
- 1408401969A
- Acronym
- WtBrFemFx
- Status last verified
- Jun 2022
- First submitted
- 8 Apr 2015
- Last updated
- 5 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: No individual participant data will be shared with other researchers. Shared group data will be presented at Orthopaedic conferences and through manuscript submission.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Weight Bearing as Tolerated Versus Protected Weight Bearing in Supracondylar Distal Femur Fractures; a Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT03167099
- Acronym / sponsor ID
- WtBrFemFx / 1408401969A
- Conditions
- Closed Supracondylar Fracture of Femur
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 25 May 2017 (actual)
- Results
- Posted 5 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to examine if immediate weight bearing on a distal femur fracture fixed with a primary locking plate, either a distal condylar locking plate or a LISS (less invasive stabilization system), is safe and promotes more rapid fracture healing than partial weight bearing, which is standard of care.
Detailed description
This study is designed to examine if immediate weight bearing on a distal femur fracture fixed with a primary locking plate, either a distal condylar locking plate or a LISS (less invasive stabilization system), is safe and promotes more rapid fracture healing than partial weight bearing, which is standard of care. Historically and currently patients are kept partial weight bearing after fixation of these fractures for 6-12 weeks until callous formation is observed on radiographs. The hypothesis is that participants allowed to bear weight immediately will heal at least as quickly as those who have weight bearing status protected with the added benefits from early mobilization. Fracture healing will be monitored closely by follow up appointments and complications will be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full Weight Bearing | Experimental | Procedure: Full Weight BearingParticipants assigned to full weight bearing after fixation of distal femur fracture. |
| Partial Weight Bearing | No intervention | –Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged > 18 yo
- distal supracondylar femur fracture (Supracondylar distal femur fractures treated with a locked plate, either a distal condylar locking plate or a LISS (less invasive stabilization system), including peri-prosthetic fractures)
- both male and female
Key exclusion criteria (6 listed)
- Patients with an intracondylar split,
- polytrauma patients with associated trauma that will inhibit their ability to weight bear,
- metastatic disease,
- incomplete follow up,
- subjects with questionable ability to bear weight (ie advanced dementia),
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 |
|---|---|---|
| Full Weight Bearingfull weight bearing after fixation of a distal femur fracture | Procedure or surgery | Full Weight Bearing |
Primary outcome
Time to Distal Femur Fracture Healing by Radiographic Evidence
Time frame: up to 12 weeks
Radiographs were analyzed postoperatively to determine bridging of 3 or 4 cortices per standard of care during follow-up office visits.
2 secondary outcomes
Time to Ambulation
Time frame: up to 24 weeks
Time of Participation in Physical Therapy
Time frame: up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No individual participant data will be shared with other researchers. Shared group data will be presented at Orthopaedic conferences and through manuscript submission.
Related trials for Closed Supracondylar Fracture of Femur
Recruiting
Robot-Assisted Closed Reduction and Internal Fixation for Distal Femoral Fractures
Supracondylar Femoral Fractures, Femoral Fractures
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.
David F Hubbard, MD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full Weight Bearing in people with Closed Supracondylar Fracture of Femur, run by West Virginia University at 1 site in United States.
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 5 Aug 2022. 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 United States. 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?
Yes. Results are posted in the registry (first posted 5 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Distal Femur Fracture Healing by Radiographic Evidence (time frame: up to 12 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 5 Aug 2022.