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Stainless steel IM nail allows reproducible open reduction of closed femur fractures
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PHOENIX — Use of a solid, stainless steel intramedullary nail allowed surgeons in developing countries who have poor access to fluoroscopy to successfully perform open reduction of closed femur fractures with a high rate of union and few complications, according to researchers from Kenya, Ethiopia and the United States.
“We see many injuries related to road traffic accidents (especially motorcycle taxis) at Tenwek (Hospital), and treat many long-bone fractures,” Daniel D. Galat, MD, of Tenwek Hospital, in Bomet, Kenya, told Orthopedics Today. “Our primary tool to treat these fractures is the [Surgical Implant Generation Network; Richland, Wash.] SIGN nail, and as part of the reporting process, we have a large database which provides critical information on the treatment of these injuries in terms of infection, union and malunion,” he said. “Our study essentially showed that treatment of closed femur fractures using the SIGN nail is safe and effective in our developing world setting.”
Issues related to follow-up
The researchers fixed closed femur fractures in 471 patients in two developing countries with the intramedullary (IM) nail. The nail was originally designed as a tibial nail, but has been used to fix femur, tibia or humerus fractures and the fixation technique is both simple and reproducible, according to Kyle R. Stephens, DO, MDiv, a fifth-year orthopedic resident at Henry Ford Macomb Hospital in Warren, Mich.
This 27-year-old man received the SIGN
nail for a malunion after a femur fracture.
Images: Stephens KR
Investigators conducted the study at Tenwek Hospital and at Soddo Christian Hospital, in Soddo, Ethiopia. More than 120,000 SIGN nails have been used in more than 55 countries, according to Stephens.
“Part of the genius of this nail is not just the engineering of being able to put two distal or interlocking screws at both ends of the nail, but placing this technology at the hands of orthopaedists all over the world and training them to do it throughout all of these hospitals,” he said.
The researchers used the online SIGN surgical database of data that were prospectively collected between 2008 and 2012 to conduct their retrospective review. They included patients only if they were evaluated at one of the hospitals at least one time and had adequate radiographs. About 50% of patients did not return for follow-up, leaving 240 patients for the final review. Most of the patients were men with midshaft femur fractures.
“When you talk about the developing world, having just one follow-up is well above average,” Stephens said.
Open reductions
The researchers open reduced the fractures in 208 patients. The patients had an average age of 40 years and the average time from injury to fracture fixation was 6.1 days. Fracture union occurred in 97% of the fractures with adequate postoperative follow-up.
Surgeons treated a 24-year-old man with a retrograde SIGN nail after he broke his leg in a motorcycle crash.
After a 28-year-old woman sustained a subtrochanteric femur fracture, she was treated with a SIGN nail.
“When your inclusion criterion is only one visit, a lot of those visits occur at 2 [weeks] or 3 weeks after surgery,” Stephens said. “Their fractures are not going to be healed that soon after surgery. Unfortunately, many of those patients just disappear [afterwards] and are not able to be contacted.”
The researchers found fractures in five proximal femurs and one distal femur were malaligned by more than 10° when they healed. There were four deep infections and one superficial infection for an overall infection rate of 2.1%. Limitations of the study included its retrospective design and low follow-up rate.
“We are forced to assume most [patients] are doing well,” Stephens said. In terms of follow-up rates, “The international average based on other papers is 25%, but ours was 50%. Follow-up is one of the greatest obstacles to performing high quality orthopedic research in developing countries,” he said. – by Renee Blisard Buddle
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Kyle R. Stephens, DO, MDiv, can be reached at Henry Ford Macomb Hospital, 32833 Bunert Rd., Warren, MI 48088, email: kylerstephens@gmail.com.
Disclosures: Galat and Stephens have no relevant financial disclosures.