Femur FractureNCT05613257
Distal Targeter vs Free-hand
A study testing Distal targeting jig and Free-hand/perfect circles technique in people with Femur Fracture and Tibial Fractures, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
This study is a randomized controlled trial comparing the use of two different surgical techniques--free-hand versus distal targeting jig-based for distal interlock screw--placement and their effects on total operative time and intraoperative radiation exposure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femur Fracture, Tibial Fractures, Nonunion of Fracture
- What is being tested?
- Distal targeting jig and Free-hand/perfect circles technique
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2022to 1 Feb 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old and above
- Undergoing intramedullary fixation of femur or tibia shaft for acute fracture or nonunion
Who cannot join
- Prior ipsilateral tibial or femoral nail
- Patients who cannot have interlocking screws placed
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: A Randomized Controlled Trial Comparing Free-Hand Versus Distal Targeting Jig-Based for Distal Interlock Screw Placement
This study is a randomized controlled trial comparing the use of two different surgical techniques--free-hand versus distal targeting jig-based for distal interlock screw--placement and their effects on total operative time and intraoperative radiation exposure.
Read the detailed description
Interlocking screw placement in intramedullary nailing of femoral and tibial shaft fractures improves rotational and length stability. However, free-hand perfect circle techniques can be technically challenging and may take up to an hour with increased radiation exposure to the surgeon and patient. Newer technologies aimed at reducing fluoroscope use such as electromagnetically-based aiming devices may increase the operative time. Proximally-based jigs have been shown to reduce fluoroscopy time in cadavers, however, have not been studied clinically. This study is a prospective, randomized controlled trial comparing a modern proximally-based distal targeting device and free-hand techniques for placement of interlocking screws in lower extremity nailing.
- Conditions
- Femur Fracture, Tibial Fractures, Nonunion of Fracture, Nonunion of Fracture of Tibia, Nonunion of Fracture of Femur (Diagnosis), Tibia Fracture
- Being tested
- Distal targeting jig, Free-hand/perfect circles technique
- Keywords
- femur fracture, tibia fracture, operative time, screw placement, jig
- Medical subject headings
- Femoral Fractures, Tibial Fractures, Fractures, Ununited, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal targeting jigDevice
Patients in this arm will have an assistive targeting device used for interlocking screw placement. The targeting device is attached to the nail proximally or distally (for antegrade or retrograde nailing, respectively) to guide screw placement through the other end of the intramedullary device.
Free-hand/perfect circles techniqueProcedure or surgery
Patients in this arm will have no assistive targeting device use and the surgeon will use a free-hand technique for the placement of interlocking screws. With this technique, fluoroscopic images are taken such that the interlocking holes of the intramedullary device are "perfect circles" and indicate that a screw introduced in the same plane that the fluoroscopic image was taken would seat perpendicularly to the intramedullary device. This is the most commonly employed technique for interlocking screw placement through intramedullary devices.
| Study group | Role | What they receive |
|---|---|---|
| Free-hand/perfect circles | Active comparator | Patients in this group will have interlocking screw placement using a free-hand, perfect circles technique. Receives: Procedure: Free-hand/perfect circles technique |
| Distal targeting jig | Experimental | Patients in this group will have interlocking screw placement using a proximally placed distal targeting jig Receives: Device: Distal targeting jig |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Radiation Exposure
Number of fluoroscopic images taken intraoperatively for screw placement and cumulative radiation exposure (in grays)
Measured: During surgery: The first fluoroscopy shot for distal interlocking screw placement to final fluoroscopy shot confirming the final screw's placement
Total Screw Placement Time
time taken to place interlocking screws
Measured: During surgery: the first fluoroscopy shot to localize the jig or obtain a perfect circle (start) to the last shot to confirm complete seating of the screw (end time)
Measurement of Screw Placement Angle
Correct screw placement is at a right (90-degree) angle from the intramedullary nail, through the interlocking screw hole
Measured: Intraoperatively (at end of surgery)
Amount of Cumulative Radiation Exposure (in Grays)
Total radiation exposure during distal screw placement
Measured: During surgery: The first fluoroscopy shot for distal interlocking screw placement to final fluoroscopy shot confirming the final screw's placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start31 Oct 2022
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
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.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Femur FractureStudies of the same condition, open and under way.
- 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
- Patients will be randomly assigned to cohorts based on the operative technique used to treat their respective fractures.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Nordic
- Responsible party
- Principal investigator, Carol A. Lin, MD, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613257
- Sponsor's protocol ID
- STUDY00001778
- Status last verified
- Apr 2025
- First submitted
- 31 Oct 2022
- Last updated
- 10 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Maqungo S, Horn A, Bernstein B, Keel M, Roche S. Distal interlocking screw placement in the femur: free-hand versus electromagnetic assisted technique (sureshot). J Orthop Trauma. 2014 Dec;28(12):e281-3. doi: 10.1097/BOT.0000000000000125.
PubMed 24714403Miclau T, Holmes W, Martin RE, Krettek C, Schandelmaier P. Plate osteosynthesis of the distal femur: surgical techniques and results. J South Orthop Assoc. 1998 Fall;7(3):161-70.
PubMed 9781891Whatling GM, Nokes LD. Literature review of current techniques for the insertion of distal screws into intramedullary locking nails. Injury. 2006 Feb;37(2):109-19. doi: 10.1016/j.injury.2005.09.009. Epub 2005 Nov 28.
PubMed 16310192Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma (PREP-IT) Investigators; Slobogean GP, Sprague S, Wells J, Bhandari M, Rojas A, Garibaldi A, Wood A, Howe A, Harris AD, Petrisor BA, Mullins DC, Pogorzelski D, Marvel D, Heels-Ansdell D, Mossuto F, Grissom F, Del Fabbro G, Guyatt GH, Della Rocca GJ, Demyanovich HK, Gitajn IL, Palmer J, D'Alleyrand JC, Friedrich J, Rivera J, Hebden J, Rudnicki J, Fowler J, Jeray KJ, Thabane L, Marchand L, O'Hara LM, Joshi MG, Talbot M, Camara M, Szasz OP, O'Hara NN, McKay P, Devereaux PJ, O'Toole RV, Zura R, Morshed S, Dodds S, Li S, Tanner SL, Scott T, Nguyen U. Effectiveness of Iodophor vs Chlorhexidine Solutions for Surgical Site Infections and Unplanned Reoperations for Patients Who Underwent Fracture Repair: The PREP-IT Master Protocol. JAMA Netw Open. 2020 Apr 1;3(4):e202215. doi: 10.1001/jamanetworkopen.2020.2215.
PubMed 32259266Stanley M, Huang K, Garlich J, Little M, Marecek G, Moon C, Vrahas M, Lin C. A Targeting Arm for Interlocking Screws Reduces Radiation Exposure: Results of a Prospective Randomized Controlled Trial. J Orthop Trauma. 2025 Dec 1;39(12):631-638. doi: 10.1097/BOT.0000000000003066.
PubMed 40892974
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Free-Hand Versus Distal Targeting Jig-Based for Distal Interlock Screw Placement
- ClinicalTrials.gov ID
- NCT05613257
- Acronym / sponsor ID
- STUDY00001778
- Conditions
- Femur Fracture, Tibial Fractures, Nonunion of Fracture, Nonunion of Fracture of Tibia, Nonunion of Fracture of Femur (Diagnosis), Tibia Fracture
- Keywords
- femur fracture, tibia fracture, operative time, screw placement, jig
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Stryker Nordic
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Posted 10 Apr 2025
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 a randomized controlled trial comparing the use of two different surgical techniques--free-hand versus distal targeting jig-based for distal interlock screw--placement and their effects on total operative time and intraoperative radiation exposure.
Detailed description
Interlocking screw placement in intramedullary nailing of femoral and tibial shaft fractures improves rotational and length stability. However, free-hand perfect circle techniques can be technically challenging and may take up to an hour with increased radiation exposure to the surgeon and patient. Newer technologies aimed at reducing fluoroscope use such as electromagnetically-based aiming devices may increase the operative time. Proximally-based jigs have been shown to reduce fluoroscopy time in cadavers, however, have not been studied clinically. This study is a prospective, randomized controlled trial comparing a modern proximally-based distal targeting device and free-hand techniques for placement of interlocking screws in lower extremity nailing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomly assigned to cohorts based on the operative technique used to treat their respective fractures.
| Arm | Type | Receives |
|---|---|---|
| Free-hand/perfect circles | Active comparator | Procedure: Free-hand/perfect circles techniquePatients in this group will have interlocking screw placement using a free-hand, perfect circles technique. |
| Distal targeting jig | Experimental | Device: Distal targeting jigPatients in this group will have interlocking screw placement using a proximally placed distal targeting jig |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years old and above
- Undergoing intramedullary fixation of femur or tibia shaft for acute fracture or nonunion
Key exclusion criteria (3 listed)
- Prior ipsilateral tibial or femoral nail
- Patients who cannot have interlocking screws placed
- Pregnant women
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 |
|---|---|---|
| Distal targeting jigPatients in this arm will have an assistive targeting device used for interlocking screw placement. The targeting device is attached to the nail proximally or distally (for antegrade or retrograde nailing, respectively) to guide screw placement through the other end of the intramedullary device. | Device | Distal targeting jig |
| Free-hand/perfect circles techniquePatients in this arm will have no assistive targeting device use and the surgeon will use a free-hand technique for the placement of interlocking screws. With this technique, fluoroscopic images are taken such that the interlocking holes of the intramedullary device are "perfect circles" and indicate that a screw introduced in the same plane that the fluoroscopic image was taken would seat perpendicularly to the intramedullary device. This is the most commonly employed technique for interlocking screw placement through intramedullary devices. | Procedure or surgery | Free-hand/perfect circles |
Primary outcome
Patient Radiation Exposure
Time frame: During surgery: The first fluoroscopy shot for distal interlocking screw placement to final fluoroscopy shot confirming the final screw's placement
Number of fluoroscopic images taken intraoperatively for screw placement and cumulative radiation exposure (in grays)
Total Screw Placement Time
Time frame: During surgery: the first fluoroscopy shot to localize the jig or obtain a perfect circle (start) to the last shot to confirm complete seating of the screw (end time)
time taken to place interlocking screws
Measurement of Screw Placement Angle
Time frame: Intraoperatively (at end of surgery)
Correct screw placement is at a right (90-degree) angle from the intramedullary nail, through the interlocking screw hole
Amount of Cumulative Radiation Exposure (in Grays)
Time frame: During surgery: The first fluoroscopy shot for distal interlocking screw placement to final fluoroscopy shot confirming the final screw's placement
Total radiation exposure during distal screw placement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24714403Maqungo S, Horn A, Bernstein B, Keel M, Roche S. Distal interlocking screw placement in the femur: free-hand versus electromagnetic assisted technique (sureshot). J Orthop Trauma. 2014 Dec;28(12):e281-3. doi: 10.1097/BOT.0000000000000125.
- Background: PubMed 9781891Miclau T, Holmes W, Martin RE, Krettek C, Schandelmaier P. Plate osteosynthesis of the distal femur: surgical techniques and results. J South Orthop Assoc. 1998 Fall;7(3):161-70.
- Background: PubMed 16310192Whatling GM, Nokes LD. Literature review of current techniques for the insertion of distal screws into intramedullary locking nails. Injury. 2006 Feb;37(2):109-19. doi: 10.1016/j.injury.2005.09.009. Epub 2005 Nov 28.
- Background: PubMed 32259266Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma (PREP-IT) Investigators; Slobogean GP, Sprague S, Wells J, Bhandari M, Rojas A, Garibaldi A, Wood A, Howe A, Harris AD, Petrisor BA, Mullins DC, Pogorzelski D, Marvel D, Heels-Ansdell D, Mossuto F, Grissom F, Del Fabbro G, Guyatt GH, Della Rocca GJ, Demyanovich HK, Gitajn IL, Palmer J, D'Alleyrand JC, Friedrich J, Rivera J, Hebden J, Rudnicki J, Fowler J, Jeray KJ, Thabane L, Marchand L, O'Hara LM, Joshi MG, Talbot M, Camara M, Szasz OP, O'Hara NN, McKay P, Devereaux PJ, O'Toole RV, Zura R, Morshed S, Dodds S, Li S, Tanner SL, Scott T, Nguyen U. Effectiveness of Iodophor vs Chlorhexidine Solutions for Surgical Site Infections and Unplanned Reoperations for Patients Who Underwent Fracture Repair: The PREP-IT Master Protocol. JAMA Netw Open. 2020 Apr 1;3(4):e202215. doi: 10.1001/jamanetworkopen.2020.2215.
- Derived from this study: PubMed 40892974Stanley M, Huang K, Garlich J, Little M, Marecek G, Moon C, Vrahas M, Lin C. A Targeting Arm for Interlocking Screws Reduces Radiation Exposure: Results of a Prospective Randomized Controlled Trial. J Orthop Trauma. 2025 Dec 1;39(12):631-638. doi: 10.1097/BOT.0000000000003066.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distal targeting jig and Free-hand/perfect circles technique in people with Femur Fracture and Tibial Fractures, run by Cedars-Sinai Medical Center 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 2 inclusion and 3 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 10 Apr 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. 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 10 Apr 2025). 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?
Patient Radiation Exposure (time frame: During surgery: The first fluoroscopy shot for distal interlocking screw placement to final fluoroscopy shot confirming the final screw's placement). The study lists 4 primary outcomes in all. 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 NCT05613257, which also lists 5 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 10 Apr 2025; AzTrials last refreshed its copy on 27 Oct 2026.