Ten BEST Orthopedic Clinical Studies of 2011

Every year approximately 600, 000 peer review articles from 5, 560 journals are published in Medline and are included in index Medicus.

Somewhere in that mountain of paper are gems. So, to help pull a few out for our readers OTW asked JBJS (Journal of Bone and Joint Surgery) editor Vernon Tolo to send along his picks of the 10 best clinical papers of 2011. We also asked AAOS (American Academy of Orthopaedic Surgeons) staff members to poll the editors at several other journals for their picks and then we conducted our own review of the most cited clinical studies published in 2011 using Google Scholar to arrive at a collection of about 50 top ranked clinical studies for 2011.

From that list we selected the Ten Best Orthopedic Clinical Papers for 2011. What did we look for?

The Qualities of a Superior Clinical Paper

Enduring clinical papers start with a hypothesis that tackles practical and difficult clinical problems. From that beginning, successful authors design study frameworks that neatly isolate independent and dependent variables. These kinds of studies articulate each variable clearly and present them so that the reader can follow their progression through the course of the study.

When it works, light bulbs go off in the reader’s mind.

Next comes the peer review process. Journals like JBJS or JAMA (Journal of American Medical Association) or Lancet put manuscripts through a gauntlet of two to four clinicians, basic scientists, methodologists or other experts. Frequently, these peer reviewers are blinded to the authors in order to assure objectivity.

As we learned through our critical review of the June issue of The Spine Journal (TSJ), there is more to peer review than just improving or approving manuscripts. Peer review must examine the quality of the scientific method from which each paper derives its intellectual authority. Scientific method establishes the connection between an idea or hypothesis and practical experience. And great papers use the scientific method to create clarity and unambiguous transparency.

Remember, clarity and transparency invites critical review and, yes, refutation through repeated re-examination by other researchers and, of course, actual clinical practice. Great clinical papers are designed to be purified and extended by mutual criticism and intellectual cooperation.

That’s the theory. In practice, again as we saw with the June issue of TSJ, researchers and editors can, like many of us lay people; prove reluctant to discard their biases even when evidence has shown them to be inadequate or invalid.

But, here is the good news; we found a group of outstanding clinical papers which meet these high standards. Here, then are our picks of the Ten Best Clinical Papers for 2011.

Ten Best Orthopedic Clinical Papers for 2011

Title: The Initial Response of GFP Reporter Periosteal Cells to Bone Fracture

Lead Author: Ushiku, C
Co-Authors: Rowe, D W; Jiang, X; Wang, L; Adams, D J

Discussion: As orthopedics moves into the era of advanced biologic and regenerative therapies, papers like this one lay the foundation for their safe and effective application in the clinical setting. Biologic therapies operate at the cellular level and this paper used a rat model to decode the spatial and temporal events that occur after bone fracture. The model used is a GFP reporter mouse which is designed to identify cells at increasing levels of differentiation within the osteoblast lineage.

In layperson’s language, the GFP reporter model allows a researcher to observe the phenomenon of bone healing following fracture in slow motion. Led by University of Kyoto Professor Ushiku, the study authors evaluated the process of fracture healing at 1, 2, 4 and 6 days with 3 mice at each time point. This study, which won an award from ORS (Orthopsedic Research Society) , contributed significantly to the understanding of fracture repair, the reasons for non-unions and lays a foundation for testing current and future regenerative therapies

Publication: Orthopedic Research Society award winning paper.

Title: Is Surgery for Cervical Spondylotic Myelopathy Cost-effective? Results of a Prospective Study with Health Utilities Assessments

Lead Author: Michael Fehlings, M.D., Ph.D., FRCSC
Co-Authors: Eric Massicotte, M.D., FRCSC, Branko Kopjar, M.D., Ph.D.,
Neilank K. Jha

Discussion: Making the case for the cost-effectiveness of spine surgery is a daily, patient by patient battle for every spine surgeon. This study tackles this very practical problem for cervical spondylotic myelophathy (CSM) surgery. To the best of the researchers’ knowledge this was the first study to analyze the cost effectiveness of this type of surgery and to find the cost-utility ratio for CSM surgery. This study earned high marks for its hypothesis, readability and clarity of its outcome measures. Further study will be required to further isolate and quantify such independent variables as comorbidities and life style factors.

Publication: North American Spine Society Value Abstract Award Winner

Title: Computer-Assisted Techniques versus Conventional Guides for Component Alignment in Total Knee Arthroplasty: A Randomized Controlled Trial

Lead Author: William G. Blakeney, MBBS
Co-Authors: Riaz J.K. Khan, MBBS, BSc(Hons), FRCS(Tr&Orth), FRACS; Simon J. Wall, MBBS, BSc(Hons), FRCS(Tr&Orth)

Discussion: Computer-assisted surgery in orthopedics is one of the fastest growing changes in the OR. The promise of such technologies is more precise alignment of components, more accurate cuts, burrs and tissue removal and, therefore, fewer complications, less OR time and better patient outcomes. This study earned high marks for stress testing this promise using a randomized controlled trial study design and isolating a clear and, presumably unambiguous independent variable – alignment accuracy. The study used three arms; one with the computer assistance and two with guides. Finally, with 107 patients in the study, the authors presented their conclusions with authority.

Publication: J Bone Joint Surg Am. 2011; 93(15):1377-1384 doi:10.2106/JBJS.I.01321

Title: The Effect of Regional Hip Capsule Defects on Total Hip Dislocation Stability – A Finite Element Analysis

Lead Author: Elkins, J M
Co-Authors: Stroud, N J; Pedersen, D R; Tochigi, Y; Rudert, M J; Ellis, B J; Callaghan, J; Weiss, J A; Brown, T D

Discussion: We admit to a bias toward finite element analysis since it can handle complicated systems like articulating joints or, for that matter, weather systems and auto crashes, and still deliver excellent predictive accuracy in a model format. That, in turn helps surgeons to visualize, understand and confidently treat complex systems like hip articulation and dislocation. Instability and dislocation is a frequent complication of THA (total hip arthroplasty) and this study put forth a clear and unambiguous hypothesis that hip capsule defects are one of its primary causes. It’s hard to go wrong with a solid hypothesis, cadaver models and a well designed finite element analysis. The authors powered up their study with 109 individual cadaveric capsules. Not only did the authors confirm that capsule defects contribute to hip instability but they also provided details. On the downside, this was a fairly densely written study, but still worth the effort.

Publication: Orthopaedic Research Society award winning paper

Title: A Prospective Randomized Controlled Trial Comparing Occupational Therapy with Independent Exercises after Volar Plate Fixation of a Fracture of the Distal Part of the Radius

Lead Author: J. Sebastiaan Souer, M.D.
Co-Authors: Geert Buijze, M.D.; David Ring, M.D., Ph.D.

Discussion: We were most impressed with the sheer practicality of the hypothesis supporting this study. The authors also earned high marks for a clear scoring method and readability. Specifically, the authors tested the effect of formal occupational therapy after open reduction and volar plate fixation of a fracture of the distal part of the radius. Their hypothesis was that there was no difference between patients who’d received formal occupational therapy and those who’d been instructed for independent exercises. This study powered up with 94 patients and reported that there was a difference and that it favored patients with prescribed independent exercises! No doubt this study will be repeated by other researchers and we look forward to seeing if life style factors like smoking, obesity, etc. affect the outcomes.

Publication: J Bone Joint Surg Am. 2011; 93(19):1761-1766 doi:10.2106/JBJS.J.01452

Title: Total Ankle Replacement in Obese Patients: Functional Outcome, Weight Change, and Component Stability in 118 Consecutive Patients

Lead Author: Alexej Barg, M.D.
Co-Authors: Markus Knupp, M.D.; Andrew E. Anderson, Ph.D.; Beat Hintermann, M.D.

Discussion: The obesity epidemic in the U.S., Europe and increasingly in Asia has been linked to poor outcomes from orthopedic surgery. To what extent does obesity affect orthopedic clinical outcomes? This study tests this hypothesis in the case of total ankle replacement surgery. The paper reviewed 118 patients who’d undergone 123 total ankle replacement surgeries over an 8-year span. The authors did an excellent job of documenting not only the specific post operative complications like DVT (deep vein thrombosis) or medial malleolar fractures, they also tracked changes in weight by age and gender and topped it off with an all encompassing VAS score.

Publication: IFFAS (International Federation of Foot & Ankle Societies)

Title: Impaired Growth of Denervated Muscle Contributes to Contracture Formation Following Neonatal Brachial Plexus Injury

Lead Author: Sia Nikolaou, Ph.D.
Co-Authors: Elizabeth Peterson, BS; Annie Kim; Christopher Wylie, Ph.D.; Roger Cornwall, M.D.

Discussion: What attracted us to this study was its novel hypothesis—that reduced growth of denervated (lacking nerve supply) muscles contributes to shoulder and elbow contractures following neonatal brachial plexus injury. We gave the authors high marks for developing a mouse model to test the hypothesis and, of course, control variables. As a result, the authors were able to articulate a new pathway for future researchers to investigate rational contracture prevention and treatments. The study was well written and we were able to easily follow the logical progression of its findings.

Publication: J Bone Joint Surg Am. 2011; 93(5):461-470 doi:10.2106/JBJS.J.00943

Title: Load Response of the Tarsal Bones in patients with Flatfoot Deformity: In vivo 3D study

Lead Author: Masamitsu Kido, M.D.
Co-Authors: Kazuya Ikoma, M.D., Ph.D.; Kan Imai, M.D., Ph.D.; Masahiro Maki, M.D., Ph.D.; Ryota Takatori, M.D., Ph.D.; Daisaku Tokunaga, M.D., Ph.D.; Nozomu Inoue, M.D., Ph.D.; Toshikazu Kubo, M.D., Ph.D.

Discussion: Will documenting bone rotation of each foot joint improve treatment plans for flat foot? That’s the question these authors explored in this particularly well designed and executed study. The authors are this year’s Roger A. Mann award winners from AOFAS (Association of Foot and Ankle Surgeos). This study simply measured bone rotation differences in each joint in the hindfoot and compared the load responses between normal and flat feet. What elevated this study even further was its use of 3D to measure the load response dynamics of the foot. The authors measured 21 patients with normal feet and 21patients with flat foot deformity. Their results clearly documented that foot joint instability occurred in the rear foot with load in patients with flatfoot deformities.

Publication: AOFAS (Association of Foot and Ankle Surgeons )

Title: Diagnosis of Early Postoperative TKA Infection Using Synovial Fluid Analysis

Lead Author: Hany Bedair
Co-Authors: Nicholas Ting, Christina Jacovides, Arjun Saxena, Mario Moric, Javad Parvizi and Craig J. Della Valle

Discussion: Post operative infections are bad news for patient and surgeon alike. While incidence rates are declining due to better OR facilities and stricter asceptic measures, the risk of infection remains one of the most troubling surgical complications. Detecting it early is one key to minimizing its impact. This study tests the hypothesis that synovial fluid can provide early evidence of infection following TKA. The authors powered up this study with 11, 964 primary TKAs and looked at 146 that had knee aspiration within 6 weeks of surgery. Infection was diagnosed in 19 of the 146 knees using positive cultures or gross purulence. The authors took care to gather demographic information, time from surgery and a variety of other test data. The study data confirmed the author’s hypothesis. White blood cell counts in synovial fluid can accurately predict infection.

Publication: Clinical Orthopaedics and Related Research Volume 469, Number 1, 34-40, DOI: 10.1007/s11999-010-1433-2

Title: Parathyroid Hormone 1-84 Accelerates Fracture-Healing in Pubic Bones of Elderly Osteoporotic Women

Lead Author: Peter Priechl, M.D.
Co-Authors: Lukas A. Holzer, M.D.; Richard Maier, M.D.; Gerold Holzer, M.D.

Discussion: The authors of this study posited a hypothesis that tackles three of the most important issues confronting surgeons today—osteoporotic bone fractures, use of trophic therapeutics in surgery and hip area fractures. Even the most casual reader is familiar with the morbidities associated with hip area fractures. Authors Priechl, Holzer L, Maier and Holzer G., effectively designed one study to knock down three questions. The design started with a focus on bone absorption scale and computed tomography—which should render irrelevant several extraneous variables like age, gender, diabetes and so forth. It focused the study clearly on compromised bone quality—regardless of the cause. But then it assembled a solid group of tests including VAS (Visual Analog Scale), timed “up and go” tests to compliment computed tomography to measure each patient’s response to PH 1-84. The authors careful description of the treatment protocols generated clear differences between the treatment and control groups earnings them high marks and, of course, recognition as one of the ten best clinical papers of 2011 from both JBJS and OTW.

Sixty-five patients were in the study. Twenty-one received once-daily injections of PTH 1-84. Time to fracture healing was 7.8 weeks in the treated group versus 12.6 weeks in the control group.

Publication: J Bone Joint Surg Am. 2011; 93(17):1583-1587 doi:10.2106/JBJS.J.01379

In conclusion, congratulations to the authors who contributed so much, so well to the advancement of orthopedic care in 2011 and also to the editors of the journals who worked with these authors to create papers with true intellectual authority.