Session III - Hip / Femur
Fri., 10/11/13 Hip/Femur, PAPER #50, 10:44 am OTA 2013
Distal Locking in Femoral and Tibial Nailing of 265 Patients Without X-Ray Guidance: A Multicenter Study
Ramon B. Gustilo, MD1; Arturo C. Canete, MD2; Godofredo V. Dungca, III, MD3;
Regidor B. De Leon, III, MD4; Daniel V. Dungca, MD5; Jereme B. Atupan, MD6;
Joaquin C. Pandanan, MD7; Wilfredo B. Pacheco, MD6; Abigail T. Jao, BS, MEM-BME8;
1Philippine Orthopedic Institute, Makati City, Philippines;
2Philippine Orthopedic Center, Quezon City, Philippines;
3Tarlac Provincial Hospital, Tarlac City, Philippines;
4East Avenue Medical Center, Quezon City, Philippines;
5Jose Reyes Memorial Medical Center, Manila, Philippines;
6University of the Philippines, Philippine General Hospital, Manila, Philippines;
7De La Salle University Medical Center, Dasmarinas City, Philippines;
8De La Salle University, Pasay City, Philippines
Purpose: This study was undertaken to determine the accuracy and safety of a new distal locking device in femoral and tibial nailing without x-ray guidance.
Methods: This new distal locking technique was used in 265 femoral and tibial patients in 69 institutions by 127 orthopaedic surgeons. Distal locking was performed using a disposable locking device inserted into the nail to create a pilot hole from inside-out of the distal femoral or tibial nail holes. The device drives a cable drill through the distal nail holes, drills from inside-out through the lateral cortex and out of the bone or skin at 90°. Using this pilot hole either from bone or skin as reference, a drilling-back technique using the cable drill wire was developed without x-ray guidance. A sounding test confirmed screw insertion and was double-checked with x-ray after surgery. Assessment of success rate and average time for locking, as well as monitoring for adverse events were conducted.
Results: 99% of patients (263 of 265) were successfully locked using the device without aid of x-ray. The 2 cases with technical problems were locked using other methods. Average time for complete distal locking was 14 minutes. No device-related adverse events were encountered.
Conclusion: Use of this innovative distal locking device was 99% effective on the first attempt. This device is easy to use, saves time, and eliminates radiation exposure to the surgical team and patient. This locking device (DISTALOCK) was approved by the US Food and Drug Administration in 2011.Alphabetical Disclosure Listing
• The FDA has not cleared this drug and/or medical device for the use described in this presentation (i.e., the drug or medical device is being discussed for an “off label” use). ◆FDA information not available at time of printing. Δ OTA Grant.