Distal Targeter vs Free-hand

Tibial Fractures Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Free-Hand Versus Distal Targeting Jig-Based for Distal Interlock Screw Placement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05613257
• Other study ID #: STUDY00001778
• Status: Completed
• Phase: N/A
• Start date: October 31, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: April 2024
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years old and above

• Undergoing intramedullary fixation of femur or tibia shaft for acute fracture or nonunion

Exclusion Criteria:

• Prior ipsilateral tibial or femoral nail

• Patients who cannot have interlocking screws placed

• Pregnant women

Related Conditions & MeSH terms

• Femoral Fractures
• Femur Fracture
• Fractures, Bone
• Fractures, Ununited
• Nonunion of Fracture
• Tibia Fracture
• Tibial Fractures

Intervention

Device:
• Distal targeting jig
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.

Procedure:
• Free-hand/perfect circles technique
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.

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	Stryker Nordic

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. Erratum In: JAMA Netw Open. 2020 Sep 1;3(9):e2021571. JAMA Netw Open. 2021 Jun 1;4(6):e2117240. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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)
Secondary	Learning curve	learning curve between distal targeter and freehand techniques stratified by level of training	Through study completion (6 month study period)
Secondary	Training methods	Correlation of sawbones-based practice and clinical practice for interlocking screw placement with regards to time taken for screw placement and accuracy of screw placement (deviation from right angle relative to intramedullary device)	Through study completion (6 month study period)