Femoral Shaft FractureNCT06160804
Evaluating Femoral Traction
A study testing Skeletal traction and Femoral shaft splinting in people with Femoral Shaft Fracture, run by University of Chicago at 1 site in United States.
Trial summary
The primary goal of this study is to test the hypothesis that skeletal traction allows for easier intraoperative reduction time by comparing the reduction time in patients that receive skeletal traction for femoral shaft fracture to those that do not. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Shaft Fracture
- What is being tested?
- Skeletal traction and Femoral shaft splinting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2024to 23 Sep 2025
- 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
- Any adult patient (ages 18 and over) with a femoral shaft fracture that is treated with intramedullary nailing within 24 hours of presentation
Who cannot join
- Patients younger than 18
- Polytraumatized patients
- Patients with pathological fractures
- Patients with femoral shaft fracture not amenable to intramedullary nailing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Skeletal Traction for Patients With Femoral Shaft Fractures Treated With Intramedullary Nailing Within 24 Hours of Presentation
The primary goal of this study is to test the hypothesis that skeletal traction allows for easier intraoperative reduction time by comparing the reduction time in patients that receive skeletal traction for femoral shaft fracture to those that do not. Secondary goals are to assess the claims of improved pain control and decreased blood loss in patients that receive skeletal traction for femoral shaft fracture to those that do not.
Read the detailed description
Traction is a practice dating back thousands of years, historically used for the definitive treatment of femoral shaft fractures. With advances in surgical care, traction is no longer regularly used for definitive treatment. However, traction is commonly used preoperatively with the claimed benefits of fracture stabilization allowing for improved pain control, restoration of limb length with easier operative reduction, and controlling bleeding by decreasing compartmental volume. However, studies have begun to question the utility of skeletal traction in patients with femoral shaft fractures.
While pre-hospital traction splints may provide added pain control for patients with femoral shaft fractures as they are transported to the hospital, skeletal traction may not provide the same pain control benefits in the inpatient setting. Dr. Bumpass and colleagues prospectively compared patients with femoral shaft fractures placed into distal femoral traction to those that were splinted. The authors demonstrated that while patients that were splinted reported higher pain scores during application, pain scores after immobilization were not different between the two groups.
Retrospective and prospective investigations of traction for femoral shaft fractures have failed to demonstrate easier operative reduction or decreased blood loss. Koerner et al retrospectively evaluated patients with femoral shaft fractures that underwent definitive intramedullary nailing within 24 hours of presentation. The authors demonstrated no difference in blood loss, transfusion requirement, or need for open reduction between patients placed in skeletal traction and patients placed in lower extremity splints. Similarly, in their randomized controlled trial Even et al demonstrated no difference in reduction time for patients with femoral shaft fractures fixed within 24 hours that received skeletal traction or skin traction preoperatively.
To the investigator's knowledge, no study has prospectively compared surgical time, pain control, and blood loss for patients that receive preoperative skeletal traction to splinting for femoral shaft fractures that receive intramedullary nailing within 24 hours of presentation.
Skeletal traction has a long history in orthopaedic surgery for the treatment of femoral shaft fractures, but may be unnecessary for patients that are surgically treated within 24 hours of presentation. The primary goal of this study is to test the hypothesis that skeletal traction allows for easier intraoperative reduction time by comparing the reduction time in patients that receive skeletal traction for femoral shaft fracture to those that do not. Secondary goals are to assess the claims of improved pain control and decreased blood loss in patients that receive skeletal traction for femoral shaft fracture to those that do not.
- Conditions
- Femoral Shaft Fracture
- Being tested
- Skeletal traction, Femoral shaft splinting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skeletal tractionProcedure or surgery
A pin through the bone with weights attached
Femoral shaft splintingProcedure or surgery
A splint of the broken thigh bone
| Study group | Role | What they receive |
|---|---|---|
| Local standard of care | Placebo comparator | Not described Receives: Procedure: Skeletal traction |
| Experimental change in care | Active comparator | Not described Receives: Procedure: Femoral shaft splinting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reduce a femoral shaft fracture
Time to reduce a femoral shaft fracture is decreased in patients that receive preoperative traction. Time measured in minutes. Short time means faster time to reduction.
Measured: Within 24 hours of presentation
Secondary outcomes (2)
Change in preoperative opiate requirement
To see if Patients that receive preoperative traction for a femoral shaft fracture have a change in preoperative opiate requirement as measured by morphine equivalents/kg/hr. More morphine means lower pain control.
Measured: 24 hours from presentation
Change in transfusion requirement
To determine if patients that receive preoperative traction for a femoral shaft fracture have a change in transfusion requirement. Measured by total liters of blood given to patient during surgery.
Measured: Within 24 hours of presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start19 Mar 2024
- Primary completion23 Sep 2025
- Study completion23 Sep 2025
Why it stopped: Enrolling subjects intro the trial was difficult. It would not have been possible to complete the study within a reasonable timeline based on the current enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Femoral Shaft FractureStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Model description
- Randomized controlled trial. Subgroups will be determined using equal block randomization. Block randomization will be used for this study. Blocks will be set to groups of 4 with each block of 4 comprising 2 traction and 2 splint opaque envelopes in random order. The envelope will be stored in the office of the principle investigator and opened following subject enrollment. This ensures subjects are blinded to their initial treatment modality. Standard of care will be followed for all clinical decisions beyond the type of stabilization procedure to be used.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Christiano, MD, Principal investigator, University of Chicago faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160804
- Sponsor's protocol ID
- IRB23-0183
- Status last verified
- May 2025
- First submitted
- 29 Nov 2023
- Last updated
- 16 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual patient data will be shared
Publications
Obey MR, Berkes MB, McAndrew CM, Miller AN. Lower-Extremity Skeletal Traction Following Orthopaedic Trauma: Indications, Techniques, and Evidence. JBJS Rev. 2019 Nov;7(11):e4. doi: 10.2106/JBJS.RVW.19.00032. No abstract available.
PubMed 31764196Even JL, Richards JE, Crosby CG, Kregor PJ, Mitchell EJ, Jahangir AA, Tressler MA, Obremskey WT. Preoperative skeletal versus cutaneous traction for femoral shaft fractures treated within 24 hours. J Orthop Trauma. 2012 Oct;26(10):e177-82. doi: 10.1097/BOT.0b013e31823a8dae.
PubMed 22430522
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Skeletal Traction for Patients With Femoral Shaft Fractures Treated With Intramedullary Nailing Within 24 Hours of Presentation
- ClinicalTrials.gov ID
- NCT06160804
- Acronym / sponsor ID
- IRB23-0183
- Conditions
- Femoral Shaft Fracture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrolling subjects intro the trial was difficult. It would not have been possible to complete the study within a reasonable timeline based on the current enrollment.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 23 Sep 2025 (actual)
- Study completion
- 23 Sep 2025 (actual)
- First posted
- 7 Dec 2023 (actual)
- 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 primary goal of this study is to test the hypothesis that skeletal traction allows for easier intraoperative reduction time by comparing the reduction time in patients that receive skeletal traction for femoral shaft fracture to those that do not. Secondary goals are to assess the claims of improved pain control and decreased blood loss in patients that receive skeletal traction for femoral shaft fracture to those that do not.
Detailed description
Traction is a practice dating back thousands of years, historically used for the definitive treatment of femoral shaft fractures. With advances in surgical care, traction is no longer regularly used for definitive treatment. However, traction is commonly used preoperatively with the claimed benefits of fracture stabilization allowing for improved pain control, restoration of limb length with easier operative reduction, and controlling bleeding by decreasing compartmental volume. However, studies have begun to question the utility of skeletal traction in patients with femoral shaft fractures.
While pre-hospital traction splints may provide added pain control for patients with femoral shaft fractures as they are transported to the hospital, skeletal traction may not provide the same pain control benefits in the inpatient setting. Dr. Bumpass and colleagues prospectively compared patients with femoral shaft fractures placed into distal femoral traction to those that were splinted. The authors demonstrated that while patients that were splinted reported higher pain scores during application, pain scores after immobilization were not different between the two groups.
Retrospective and prospective investigations of traction for femoral shaft fractures have failed to demonstrate easier operative reduction or decreased blood loss. Koerner et al retrospectively evaluated patients with femoral shaft fractures that underwent definitive intramedullary nailing within 24 hours of presentation. The authors demonstrated no difference in blood loss, transfusion requirement, or need for open reduction between patients placed in skeletal traction and patients placed in lower extremity splints. Similarly, in their randomized controlled trial Even et al demonstrated no difference in reduction time for patients with femoral shaft fractures fixed within 24 hours that received skeletal traction or skin traction preoperatively.
To the investigator's knowledge, no study has prospectively compared surgical time, pain control, and blood loss for patients that receive preoperative skeletal traction to splinting for femoral shaft fractures that receive intramedullary nailing within 24 hours of presentation.
Skeletal traction has a long history in orthopaedic surgery for the treatment of femoral shaft fractures, but may be unnecessary for patients that are surgically treated within 24 hours of presentation. The primary goal of this study is to test the hypothesis that skeletal traction allows for easier intraoperative reduction time by comparing the reduction time in patients that receive skeletal traction for femoral shaft fracture to those that do not. Secondary goals are to assess the claims of improved pain control and decreased blood loss in patients that receive skeletal traction for femoral shaft fracture to those that do not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial. Subgroups will be determined using equal block randomization. Block randomization will be used for this study. Blocks will be set to groups of 4 with each block of 4 comprising 2 traction and 2 splint opaque envelopes in random order. The envelope will be stored in the office of the principle investigator and opened following subject enrollment. This ensures subjects are blinded to their initial treatment modality. Standard of care will be followed for all clinical decisions beyond the type of stabilization procedure to be used.
| Arm | Type | Receives |
|---|---|---|
| Local standard of care | Placebo comparator | Procedure: Skeletal traction |
| Experimental change in care | Active comparator | Procedure: Femoral shaft splinting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any adult patient (ages 18 and over) with a femoral shaft fracture that is treated with intramedullary nailing within 24 hours of presentation
Key exclusion criteria (4 listed)
- Patients younger than 18
- Polytraumatized patients
- Patients with pathological fractures
- Patients with femoral shaft fracture not amenable to intramedullary nailing
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 |
|---|---|---|
| Skeletal tractionA pin through the bone with weights attached | Procedure or surgery | Local standard of care |
| Femoral shaft splintingA splint of the broken thigh bone | Procedure or surgery | Experimental change in care |
Primary outcome
Time to reduce a femoral shaft fracture
Time frame: Within 24 hours of presentation
Time to reduce a femoral shaft fracture is decreased in patients that receive preoperative traction. Time measured in minutes. Short time means faster time to reduction.
2 secondary outcomes
Change in preoperative opiate requirement
Time frame: 24 hours from presentation
Change in transfusion requirement
Time frame: Within 24 hours of presentation
Results and safety
The study was stopped early (reason given: Enrolling subjects intro the trial was difficult. It would not have been possible to complete the study within a reasonable timeline based on the current enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Background: PubMed 31764196Obey MR, Berkes MB, McAndrew CM, Miller AN. Lower-Extremity Skeletal Traction Following Orthopaedic Trauma: Indications, Techniques, and Evidence. JBJS Rev. 2019 Nov;7(11):e4. doi: 10.2106/JBJS.RVW.19.00032. No abstract available.
- Background: PubMed 22430522Even JL, Richards JE, Crosby CG, Kregor PJ, Mitchell EJ, Jahangir AA, Tressler MA, Obremskey WT. Preoperative skeletal versus cutaneous traction for femoral shaft fractures treated within 24 hours. J Orthop Trauma. 2012 Oct;26(10):e177-82. doi: 10.1097/BOT.0b013e31823a8dae.
- Individual participant dataSharing planned: No. No individual patient data will be shared
Related trials for Femoral Shaft Fracture
Not yet recruiting
Rehabilitation After Lower Extremity Nailing Trial
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Recruiting
Robot-Assisted Closed Reduction and Internal Fixation for Femoral Shaft Fractures
Femoral Shaft Fractures, Femur Fractures
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Feasibility of Structured Resistance Training After Lower Extremity Fracture
Lower Extremity Fractures
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Retrograde Femoral Nail-Advanced Outcomes for Fixation of Distal Femur and Femoral Shaft Fractures
Femoral Fracture
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Assessing Bone Fracture Healing Effect of Almonds
Femur Shaft Fracture, Tibia 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.
Anthony Christiano, MD principal investigator
University of Chicago faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skeletal traction and Femoral shaft splinting in people with Femoral Shaft Fracture, run by University of Chicago 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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 16 Oct 2025. 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. Some participants in this study may receive a placebo. 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 stopped early (reason given: Enrolling subjects intro the trial was difficult. It would not have been possible to complete the study within a reasonable timeline based on the current enrollment.). Results are not available in the source record.
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 reduce a femoral shaft fracture (time frame: Within 24 hours of presentation). 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 NCT06160804, which also lists 2 linked publications.
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 16 Oct 2025.