Conducting clinical research can be challenging. The challenges are derived from not only the logistical difficulties of proper scientific conduct but also the many regulatory bodies that are in place to safeguard against harm in subjects involved in clinical research. With the advent of the role of the Clinical Research Coordinator (CRC) these challenges have improved. However, many don't understand the exact role of the CRC.

Grimm NL, Tainter DM. Role of the Clinical Research Coordinator in Orthopaedic Research: Making Research Less Onerous. The Duke Orthop J 2017;7(1):1-2.

The role of powder gloves in allergic reactions, infections, wound healing and granuloma formation has been known for many years. Despite a gradual shift away from powder gloves over the last several decades, many healthcare professionals and facilities continue to use powder gloves as the FDA has continued to refrain from issuing a comprehensive formal ban. However, recent advancements in glove technology and position statements by professional societies have continued the push for removal of powder gloves from all clinical and surgical settings and will hopefully entirely eradicate usage in the coming years.

Blizzard DJ, Agaba P, Morwood MP, Jerele JL, Zura RD. Risks and Benefits of the different Types of Gloves used in the Perioperative Setting. The Duke Orthop J 2017;7(1):3-10.

The increasing adoption of electronic medical record (EMR) systems has added complexity to performing clinical research in today's care environment. Each of the contributions from Duke University within this journal has interfaced with the systems for performing clinical research described in this study. While the increased use of EMRs has aided many aspects of clinical care, the logistics of doing the work of clinical research is seldom discussed. In this review, we briefly outline current practices regarding clinical research as they relate to interface with the EMR.

Olson SA, Manson M. Logistics of Clinical Research in the Age of Electronic Medical Records. The Duke Orthop J 2017;7(1):11-13.

The article reviews milestones in spine care that have occurred in the past 100 years. The various conditions and diagnoses we commonly treat today were poorly understood and there were few reliable treatments available in the first half of the twentieth century. Various diagnostic and imaging techniques have evolved as well as nonoperative and operative modalities to treat deformity, degenerative, and traumatic spine conditions. The reader should gain an understanding and appreciation of how interrelated the early concepts of management and treatment relate to the procedures and technology we take for granted today.

Nasca RJ. Highlights in Spine Care during the Last One Hundred Years. The Duke Orthop J 2017;7(1):14-22.

Amputations secondary to high-energy open fractures and blast, ballistic, and crush injuries to the lower extremity are common challenges faced by military and civilian orthopaedic surgeons. A lack of consensus on domains to be measured and quality of prosthetic rendering pose methodological challenges to researchers and clinicians alike. We conducted a systematic review of the literature to summarize which domains of health, prosthetic fit, and prosthetic alignment are used to describe outcomes for lower extremity amputees secondary to trauma.

A search of PubMed, Cochrane, and Embase was conducted including the keywords: Amputation, traumatic, transtibial, survey, and metric. Articles were selected based on whether the study assessed clinical outcomes following transtibial amputation following trauma. Experimental and observational comparative studies and case series were included. Study characteristics and results were extracted using standardized data forms. The number of unique measures recorded, the frequency of measure use, and the number outcome measures were validated and were compiled.

Literature search ultimately resulted in 273 articles being included. A conceptual model was constructed to capture and organize the causal and temporal relationships between fit, alignment, and outcome. Of the 68 articles that used questionnaires to assess prosthetic fit, 37 used a questionnaire designed specifically for the study as opposed to a published or validated tool. Four validated tools were commonly used to capture patient satisfaction with a prosthesis: The OPUS, PEQ, TAPES, and the Socket Comfort Fit Score. Prosthetic alignment was assessed in 19 of 273 articles. One article validated the use of an alignment jig for quantification and prescription of prostheses. Totally, 8 of 19 articles assessing alignment used gait analysis and ground reaction forces to capture differences due to alterations in alignment.

Choice of an appropriate outcome measure is critical in generating evidence to support treatment decisions for patients undergoing transtibial amputation after trauma. We found a large number of different tools being used across studies, making results difficult to compare. Prosthetic fit and comfort of the residual limb in the socket and the alignment of the socket and the shank of the prosthesis make up the foundation for the proposed conceptual model. In order to distinguish effects attributable to an intervention of interest vs the impact of the quality of the socket fitting, validation of a clinically objective scoring system to assess socket fit is necessary.

A large number of different tools are currently being used across studies to assess outcomes for transtibial amputees resulting from trauma, and there is a need for development and validation of a clinically objective scoring system to assess socket fit.

Baumgartner R, Morshed S. Assessment Measures for Evaluation of Outcomes in Transtibial Amputees resulting from Trauma: A Systematic Review. The Duke Orthop J 2017;7(1):23-29.

We report 3 cases of preoperative deep vein thrombosis (DVT) following anterior cruciate ligament (ACL) injury in a 20-year-old female volleyball player (C1), a 22-year-old female snowboarder (C2), and a 36-year-old male recreational basketball player (C3). In all three cases, the patients presented with hypersensitivity in the injured knee and guarded significantly on physical examination. The patients were all placed on anticoagulation prior to operative intervention. C1 underwent repair 45 days after her injury and C2 delayed repair until completion of a 6 month course of warfarin. C3 did not undergo repair of the ACL; he developed significant stiffness and had diagnostic arthroscopy with lysis of adhesions and synovectomy 5 months following his injury.

Data is limited regarding the risk of DVT after nonmajor orthopaedic injury, such as ACL injury. Recognition and immediate treatment of the DVT is essential in minimizing the risk of additional complications. Duration of anticoagulation and delay in surgical intervention should be determined based on individual patient goals and risk factors.

Baumgartner RE, Jones MD, Hame SL, McAllister DR. Preoperative Deep Vein Thrombosis following Acute Anterior Cruciate Ligament Tear: Report of Three Cases. The Duke Orthop J 2017;7(1):30-33.

Mesenchymal stem cells (MSCs) are multipotent cells with potential reparative properties for connective tissues, such as articular cartilage. The Lipogems adipose graft harvest system is a relatively novel technique for harvesting adipose-derived MSCs and may be utilized in conjunction with various orthopaedic sports medicine procedures.

Owusu-Akyaw KA, Godin J, Pecchia S, Oldweiler A, Moorman CT. Adipose-derived Mesenchymal Stem Cells and Arthroscopic Surgery. The Duke Orthop J 2017;7(1):34-38.

Many total hip arthroplasties are complicated by severe acetabular bone loss, limiting reconstruction options. This case report details the use of a 54-mm trabecular metal straight buttress and press-fit jumbo cup to reconstruct an especially large superior and medial defect (Paprosky type IIIB). Specifically, the large defect was reconstructed by placing the augment superior-medially in the acetabular defect instead of simply superiorly and attached to the iliac wing as it is more commonly employed. To our knowledge, there has been no reported use of a similar augment to fill such a defect in this way. This technique represents a promising potential option for reconstruction of especially large superior and medial acetabular defects

Scott DJ, Jennings JM, Bolognesi MP. Novel Use of a Trabecular Metal Augment in a Severe Acetabular Defect. The Duke Orthop J 2017;7(1):39-42.

Ulnar nerve (UN) and cubital tunnel morphology is influenced by elbow positioning, potentially compromising injection accuracy and placing the nerve at risk during cubital tunnel injection.

Based on previous anatomical studies of the cubital tunnel, a proof of concept injection model was developed. Eighteen above-elbow cadaver specimens were positioned in 45° elbow flexion and in neutral forearm rotation. The ultrasound transducer was oriented in the transverse plane, in-line with the medial epicondyle and olecranon tip, facilitating visualization of the UN and cubital tunnel. A 25-gauge needle oriented parallel to the ulna was inserted percutaneously at the midpoint between olecranon and epicondyle. The needle was advanced under ultrasound guidance to replicate injection and was secured. Open dissection confirmed its location.

18/18 needle tips were within the cubital tunnel and no needles penetrated the UN.

Ultrasound-guided cubital tunnel injection, with the elbow in 45° flexion and with neutral forearm rotation was a safe and reliable technique in this cadaveric model. Future clinical studies may evaluate the efficacy of both diagnostic and therapeutic cubital tunnel injection.

Nickel BT, Richard MJ, Cotterell I, Crosmer M, Ruch DS, Leversedge FJ. Ultrasound-guided Cubital Tunnel Injection: Description of Technique and Accuracy in a Cadaver Model. The Duke Orthop J 2017;7(1):43-45.

Field measurement of core temperature typically requires rectal or other invasive, expensive core temperature methods. Infrared (IR) thermography uses a handheld camera to measure surface temperature at discrete locations. We attempted to validate IR thermography against core-temperature capsules for the tracking of core-temperature changes at rest, during exercise, and recovery.

Infrared thermography is a noninvasive method to follow changes in core temperature during exercise.

Twelve athletes swallowed an ingestible core-temperature (CorTemp) capsule 1-hour prior to exercise. Athletes refrained from drinking for 2 hours prior to or during the study. Temperatures were obtained using both the CorTemp capsule and IR thermography at 10-minute intervals for 30 minutes before exercise, during 30 minutes of moderate intensity aerobic exercise, and for 30 minutes of recovery. The temperatures were then averaged for each segment of data collection.

Prospective descriptive study.

Infrared thermography results (rest = 34.7°C C 0.49, exercise = 34.1°C ± 0.77, recovery = 34.6°C ± 0.46) were significantly lower than with the CorTemp capsules (rest = 37°C ± 0.55, exercise = 38.6°C ± 0.47, recovery = 37.7°C ± 0.47) throughout the data collection period. There were no significant correlations between the two measurement methods (rest = 0.22, exercise = 0.07, recovery = 0.59; all p > 0.05).

Infrared thermography is not a valid method to track core-temperature changes during exercise. In addition to IR thermography readings being consistently lower, temperature changes before, during, and after exercise showed wide and inconsistent variability.

Boggess BR, Stafford H, Moorman CT III, Berkoff DJ. Infrared Thermography: Not a Valid Method to Track Changes in Core Temperature in Exercising Athletes. The Duke Orthop J 2017;7(1):46-50.

To evaluate the safety of hip arthroscopy combined with a periacetabular osteotomy (PAO) compared with PAO alone in treating concomitant intra-articular pathology in hip dysplasia.

Forty-one patients (46 hips) with symptomatic hip dysplasia were retrospectively reviewed. Pre- and postoperative radiographic data and intraoperative data consisting of estimated blood loss, intraoperative and postoperative blood transfusions, operative time, and length of hospital stay were recorded. The complications occurring within the first 3 months after surgery including lateral femoral cutaneous and pudendal nerve neuropraxia, wound complications, and reoperations were recorded. Additionally, rates of deep venous thrombosis and other major adverse outcomes (myocardial infarction, pulmonary embolism, stroke, death) were examined.

Twenty-one patients (24 hips) underwent PAO alone. Twenty patients (22 hips) underwent hip arthroscopy followed immediately by PAO. There were no significant differences in the 90-day complication rates between the two groups, comparing the rate of neuropraxia (p = 0.155) and wound complications (p = 0.6). Operative time for PAO alone was 179 minutes (standard deviation [SD] ± 37) compared with 251 minutes (SD ± 52) for combined hip arthroscopy and PAO (p < 0.001). No incidence of deep vein thrombosis or major adverse events was noted in either group. Preoperative lateral center edge angle (LCEA) and acetabular index (AI) were 14° and 20° respectively, in the PAO-alone group and 19° and 16° respectively, in the combined group. Postoperatively, LCEA was 29° in the PAO-alone group and 30° in the combined group. Postoperative AI was 11° in the PAO-alone group and 5° in the combined group.

This study demonstrates that hip arthroscopy in combination with PAO to treat intra-articular pathology shows no difference in 90-day complication rates when compared with PAO alone.

Level III, retrospective comparative study

Neumann JA, Rickert KD, Bradley KE, Lewis BD, France MA, Olson SA. Concomitant Hip Arthroscopy and Periacetabular Osteotomy: Is there a Difference in Perioperative Complications compared with Periacetabular Osteotomy Alone? The Duke Orthop J 2017;7(1):51-57.

Following successful closed reduction, the ideal timing of operative fixation for ankle fracture–dislocations is not well understood. We sought to describe the rate at which initial reduction is lost between the Emergency Department (ED) and clinic visits, and to identify factors associated with loss of reduction.

We identified 30 patients with isolated, closed ankle fracture–dislocations that were successfully reduced and splinted in the ED prior to operative intervention. The maintenance of reduction at follow-up clinic visit was defined as a success, and loss of reduction was defined as a failure.

There were 17 (57%) successes and 13 (43%) failures. When the ratio of posterior malleolus (PM) fracture fragment size to complete articular surface was >0.1, rate of failure was 65% compared with 18% when the ratio was ≤0.1 (p = 0.016).

Ankle fracture–dislocations with a larger PM fracture fragment size may warrant consideration of earlier operative intervention.

IV, Case Series.

Matson AP, Green CL, Hurwitz SR, Zura RD. Stability of Ankle Fracture–dislocations following Successful Closed Reduction. The Duke Orthop J 2017;7(1):58-63.