Distal Targeter vs Free-hand

NCT05613257 | Completed Results DMC FDA Device

• 1 other identifier: STUDY00001778
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (4)

• Patient Radiation Exposure

  Number of fluoroscopic images taken intraoperatively for screw placement and cumulative radiation exposure (in grays)

  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

  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

  Intraoperatively (at end of surgery)

• Amount of Cumulative Radiation Exposure (in Grays)

  Total radiation exposure during distal screw placement

  During surgery: The first fluoroscopy shot for distal interlocking screw placement to final fluoroscopy shot confirming the final screw's placement

Study Arms (2)

Free-hand/perfect circles

ACTIVE COMPARATOR

Patients in this group will have interlocking screw placement using a free-hand, perfect circles technique.

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

Device: Distal targeting jig

Interventions

Distal targeting jig DEVICE

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.

Distal targeting jig

Free-hand/perfect circles technique PROCEDURE

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.

Free-hand/perfect circles

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old and above
• Undergoing intramedullary fixation of femur or tibia shaft for acute fracture or nonunion

You may not qualify if:

• Prior ipsilateral tibial or femoral nail
• Patients who cannot have interlocking screws placed
• Pregnant women

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Stryker Nordic: collaborator

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (5)

• 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.

  PMID: 24714403 BACKGROUND

• Miclau 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.

  PMID: 9781891 BACKGROUND

• Whatling 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.

  PMID: 16310192 BACKGROUND

• Program 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.

  PMID: 32259266 BACKGROUND

• Stanley 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.

  PMID: 40892974 DERIVED

MeSH Terms

Conditions

Femoral Fractures; Tibial Fractures; Fractures, Ununited; Disease

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Joel Arnold
• Organization: Cedars Sinai Medical Center

joel.arnold@cshs.org

310-423-9839

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Patients will be randomly assigned to cohorts based on the operative technique used to treat their respective fractures.

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 14, 2022
• Study Start: October 31, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: April 10, 2025
• Results First Posted: April 10, 2025

Record last verified: 2025-04

Locations

US (1)