Clinical trial NCT05613257: Distal Targeter vs Free-hand
Official title: A Randomized Controlled Trial Comparing Free-Hand Versus Distal Targeting Jig-Based for Distal Interlock Screw Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Stryker Nordic
First posted: 2022-11-14
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly assigned to cohorts based on the operative technique used to treat their respective fractures.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Radiation Exposure
timeFrame: During surgery: The first fluoroscopy shot for distal interlocking screw placement to final fluoroscopy shot confirming the final screw's placement
measure: Total Screw Placement Time
timeFrame: 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)
measure: Measurement of Screw Placement Angle
timeFrame: Intraoperatively (at end of surgery)
measure: Amount of Cumulative Radiation Exposure (in Grays)
timeFrame: During surgery: The first fluoroscopy shot for distal interlocking screw placement to final fluoroscopy shot confirming the final screw's placement
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
References:
citation: 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.
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.
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.
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.