High-Level Clinical Research in Developing Countries? Yes!
Generally speaking, orthopaedic surgeons in low-resourced environments deliver the best care for their patients with skill, creativity, and passion. These surgeons are accustomed to scrambling for implants and other tools and to working around limited access to operating theaters and anesthesia services. Their everyday struggles usually leave little energy or time to even think about clinical research.
However, in the May 20, 2020 issue of The Journal, Haonga and colleagues prove that, with a “little help from their friends,” it is possible to conduct Level I research while treating patients in a resource-limited setting. They enrolled and followed 221 patients with open tibial fractures (mostly males in their 30s injured in a road-traffic collision) and randomized them to treatment with either uniplanar external fixation or intramedullary (IM) nailing. The nails were supplied by SIGN Fracture Care International, a not-for-profit humanitarian organization that provides specially designed IM nails that can be used without image intensification to hospitals in developing countries around the world. (See related OrthoBuzz post.)
The research was done in Dar es Salaam, Tanzania, in collaboration with trauma surgeons and epidemiologists from the University of California San Francisco, which has a long-standing relationship with Tanzania’s Muhimbili National Hospital. At the 1-year follow-up, there were no significant between-group differences in primary-outcome events—death or reoperation due to deep infection, nonunion, or malalignment. IM nailing was associated with a lower risk of coronal or sagittal malalignment, and quality-of-life (QoL) scores favored IM nailing at 6 weeks, but QoL differences dissipated by 1 year.
Just as important as the clinical findings, these investigators proved that it is possible to do high-level research in centers with high patient volume and limited resources. Future patients will benefit because the clinicians now have better information to share regarding expectations for functional recovery and risk of infection. Physicians and other healthcare professionals benefit because data like this help improve their analytical skills and become more discerning appraisers of the published literature. With strong internal physician leadership and a little outside support, Haonga et al. have convinced us that prospective—and even randomized—research is possible in these special places.
Finally, SIGN deserves our support as a true champion of orthopaedic surgeons working in under-resourced environments. In addition to providing education and implants, SIGN surgeons are required to report their cases through the SIGN Surgical Database—which encourages the research mindset and helps SIGN surgeons improve tools and techniques for better patient outcomes.
Marc Swiontkowski, MD
JBJS Editor-in-Chief
JBJS 100: Juvenile Rheumatoid Arthritis, Tibial Fracture Healing
Under one name or another, The Journal of Bone & Joint Surgery has published quality orthopaedic content spanning three centuries. In 1919, our publication was called the Journal of Orthopaedic Surgery, and the first volume of that journal was Volume 1 of what we know today as JBJS.
Thus, the 24 issues we turn out in 2018 will constitute our 100th volume. To help celebrate this milestone, throughout the year we will be spotlighting 100 of the most influential JBJS articles on OrthoBuzz, making the original content openly accessible for a limited time.
Unlike the scientific rigor of Journal content, the selection of this list was not entirely scientific. About half we picked from “JBJS Classics,” which were chosen previously by current and past JBJS Editors-in-Chief and Deputy Editors. We also selected JBJS articles that have been cited more than 1,000 times in other publications, according to Google Scholar search results. Finally, we considered “activity” on the Web of Science and The Journal’s websites.
We hope you enjoy and benefit from reading these groundbreaking articles from JBJS, as we mark our 100th volume. Here are two more:
Changes in the Cervical Spine in Juvenile Rheumatoid Arthritis
R N Hensinger, P D DeVito, C G Ragsdale: JBJS, 1986 January; 68 (2): 189
This study of 121 patients with juvenile rheumatoid arthritis (RA) found that severe neck pain was not common, although neck stiffness and radiographic changes were commonly seen in the subset of patients with polyarticular-onset disease. The authors concluded that patients with juvenile RA who present with evidence of disease in the cervical spine should be examined carefully for involvement of multiple joints.
A Functional Below-the-Knee Cast for Tibial Fractures
A Sarmiento: JBJS, 1967 July; 49 (5): 855
In this report of 100 consecutive tibial shaft fractures, Gus Sarmiento encouraged early weight bearing in a skin-tight plaster cast that was molded proximally to contain the muscles of the leg. All 100 fractures healed, and healing occurred with minimal deformity or shortening. While most tibial shaft fractures are now treated with intramedullary nails, the principles developed by Dr. Sarmiento still apply, as the nail acts much like the fracture brace to maintain alignment during the weight-bearing healing process.
What’s New in Orthopaedic Trauma
Every month, JBJS publishes a Specialty Update—a review of the most pertinent and impactful studies published in the orthopaedic literature during the previous year in 13 subspecialties. Click here for a collection of all OrthoBuzz Specialty Update summaries.
This month, David Teague, MD, co-author of the July 7, 2016 Specialty Update on orthopaedic trauma, selected the eight most clinically compelling findings from among the 35 studies summarized in the Specialty Update.
Shoulder
–The randomized PROFHER trial found that surgical treatment of acute displaced proximal humeral fractures (with either ORIF or hemiarthroplasty) yielded no difference in patient outcomes compared with nonsurgical sling treatment at time points up to 2 years. Surgery was also significantly more expensive.1
Wrist
–A randomized trial of 461 patients with an acute dorsally displaced distal radial fracture found no difference at one year in primary or secondary outcomes between a group that received ORIF and a group that received Kirschner-wire fixation. K-wire fixation was also more cost-effective.2
Tibia
–A retrospective study of 137 type-III open tibial fractures concluded that both antibiotic prophylaxis and definitive wound coverage should occur as soon as possible for severe open tibial fractures. Prehospital antibiotic administration should be considered when transport is expected to take longer than one hour. 3
Ankle
–A randomized trial of 214 patients who received either supervised physical therapy or engaged in self-directed home exercise after six weeks of immobilization treatment for an ankle fracture found no difference in activity and quality-of-life outcomes at 1, 3, and 6 months.4
Managing Thromboembolism
–A registry study examining the incidence of deep venous thrombosis (DVT)/pulmonary embolism (PE) after surgery for a fracture distal to the knee identified the following risk factors for a thromboembolic event: previous DVT or PE, oral contraceptive use, and obesity.
Wound Care
–A randomized controlled trial of 2,447 patients compared irrigation with normal saline solution at various pressures to castile soap irrigation. Saline was superior in terms of reoperation rates after 12 months but irrigation pressure did not influence the reoperation rate.5
–A retrospective cohort study involving 104 patients who required a fasciotomy found that hospital stays were shorter among patients who underwent delayed primary closure (DPC) or a split-thickness skin graft on the first post-fasciotomy surgery. The authors noted limited utility of repeat surgeries to achieve DPT if fasciotomy wounds were not closed primarily on the first return trip.6
Obesity
–A prospective observational study of 376 trauma patients requiring orthopaedic surgery found that those with a BMI of >30 kg/m2 had an overall complication rate of 38% and had longer hospital stays, longer delays to definitive fixation, and higher infection rates than nonobese patients.7
References
- Rangan A, Handoll H, Brealey S, Jefferson L, Keding A, Martin BC, Goodchild L, Chuang LH, Hewitt C,Torgerson D; PROFHER Trial Collaborators. Surgical vs nonsurgical treatment of adults with displaced fractures of the proximal humerus: the PROFHER randomized clinical trial. JAMA. 2015 Mar 10;313(10):1037-47.
- Costa ML, Achten J, Plant C, Parsons NR, Rangan A, Tubeuf S, Yu G, Lamb SEUK. UK DRAFFT: a randomised controlled trial of percutaneous fixation with Kirschner wires versus volar locking-plate fixation in the treatment of adult patients with a dorsally displaced fracture of the distal radius. Health Technol Assess.2015 Feb;19(17):1-124: v-vi
- Lack WD, Karunakar MA, Angerame MR, Seymour RB, Sims S, Kellam JF, Bosse MJ. Type III open tibia fractures: immediate antibiotic prophylaxis minimizes infection. J Orthop Trauma. 2015 Jan;29(1):1-6.
- Moseley AM, Beckenkamp PR, Haas M, Herbert RD, Lin CW; EXACT Team. Rehabilitation after immobilization for ankle fracture: the EXACT randomized clinical trial. JAMA. 2015 Oct 6;314(13):1376-85.
- Bhandari M, Jeray KJ, Petrisor BA, Devereaux PJ, Heels-Ansdell D, Schemitsch EH, Anglen J, Della RoccaGJ, Jones C, Kreder H, Liew S, McKay P, Papp S, Sancheti P, Sprague S, Stone TB, Sun X, Tanner SL,Tornetta P 3rd., Tufescu T, Walter S, Guyatt GH; FLOW Investigators. A trial of wound irrigation in the initial management of open fracture wounds. N Engl J Med. 2015 Dec 31;373(27):2629-41. Epub 2015 Oct 8.
- Weaver MJ, Owen TM, Morgan JH, Harris MB. Delayed primary closure of fasciotomy incisions in the lower leg: do we need to change our strategy? J Orthop Trauma. 2015 Jul;29(7):308-11.
- Childs BR, Nahm NJ, Dolenc AJ, Vallier HA. Obesity is associated with more complications and longer hospital stays after orthopaedic trauma. J Orthop Trauma. 2015 Nov;29(11):504-9.
JBJS Reviews Editor’s Choice–Open Tibial Fractures
Orthopaedic surgeons have developed a heightened awareness of the scientific evidence that supports the decisions that they make in the care of patients. Levels of evidence and grades of recommendation have been used in scientific articles in order to frame information in an evidence-based manner. However, despite the substantial strides that have been made in promoting evidence-based practice throughout orthopaedic surgery, some historical dogma still exists and many surgeons do things based on what they were told or taught many years ago. One example is the so-called “six-hour rule,” in which it is considered the standard of care to urgently perform irrigation and debridement of an open tibial fracture within six hours after the time of injury.
Fractures of the tibial diaphysis are among the most common major long-bone fractures treated by orthopaedic surgeons. Up to 24% of these fractures present as open injuries, and a considerable portion are associated with severe soft-tissue compromise. Open tibial fractures receive different levels of treatment based on the severity of the injury according to the Gustilo and Anderson classification system. In the February 2015 edition of JBJS Reviews, Mundi et al. explore the practice patterns and clinical evidence to support four aspects of treatment that are essential to the management of open tibial fractures: irrigation and debridement, antibiotic prophylaxis, fracture stabilization, and wound management.
With regard to irrigation and debridement, although timely treatment within six hours after injury is considered the standard of care, there is insufficient evidence to support this practice. Moreover, the ideal irrigation solution and the optimum pressure of the irrigation are unknown.
Information on the use of antibiotics in the management of open tibial fractures is based on various well-designed studies, so the quality of the evidence to support some of these recommendations is better. Investigators agree that antibiotic prophylaxis should be started as soon as possible after presentation to an emergency department or hospital and that patients should receive antimicrobial coverage against gram-positive bacteria, typically with a first-generation cephalosporin. Gustilo and Anderson type-III injuries require additional antibiotic coverage, and the use of aminoglycosides is indicated, although the optimum regimen has not been established. Local antibiotic administration at the site of the injury (e.g., antibiotic-laden cement beads) is potentially beneficial but is primarily used for patients with type-III injuries.
The optimum time for closure of these wounds has yet to be determined, although primary closure is warranted under specific circumstances. For those injuries that require delayed closure, definitive coverage should not be delayed beyond seven days, even in the setting of negative-pressure wound therapy.
With regard to stabilization, techniques for the operative management of open tibial fractures have evolved and current evidence shows superior outcomes in association with intramedullary nailing as compared with plate fixation. However, there had been a debate regarding reamed versus unreamed intramedullary nailing. Interestingly, a randomized controlled trial was conducted to answer this question, and the results showed that both reamed and unreamed intramedullary nailing are reasonable options for the fixation of open tibial fractures, with the two techniques demonstrating comparable outcomes.
At this time, there remains a need for additional high-quality evidence to clarify the efficacy of specific techniques and treatments. In particular, guidelines detailing the optimal irrigation solution and pressure as well as the ideal duration of antibiotic prophylaxis are needed. Continued efforts to design and organize large-scale randomized clinical trials will be required in order to provide the kind of evidence that orthopaedic surgeons need so that they can provide the best care for their patients.
Thomas A. Einhorn, MD, Editor
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