CLINICAL RESEARCH DEPARTMENT

.

In 2010, OAD Orthopaedics created a Clinical Research Department to further OAD's advanced and innovative specialty care and services. Participation in clinical research presents opportunities for physicians and clinicians to expand upon their expertise by examining data and outcomes within their areas of subspecialization.

.

Currently, OAD is involved in the following investigator-initiated studies (i.e., research OAD developed):

.

• Foot Pronation and Greater Trochanteric Hip Pain: A Correlational Pilot Study
  
  Principal Investigator: Beth Froese, MD
  Co-Investigators: Therese Southworth, PT, OCS, Kaarthick Mani, PT, DPT, MS
  Study Start Date: January 2012
  
  • The study is being done to evaluate the correlation between foot pronation and hip greater trochanteric pain in the female population.
  • Patient participation consists of a onetime physical assessment which includes a measurement of hip pain and subsequent measurement of foot pronation.
  
• A Randomized Trial to Assess the Effectiveness of an Off-Loading Knee Brace When Combined with Viscosupplementation in the Treatment of Knee Osteoarthritis

  
  Principal Investigator: William Sterba, M.D.
  Co-Investigators: David Mochel, M.D., Marjorie Delaney, APN
  Study Start Date: January 2012
  
  • Study will document the efficacy of two common treatments for mild to moderate knee osteoarthritis.
  • Patients will be randomized into one of three study groups; an off-loading knee brace, viscosupplementation, and/or an off-loading knee brace and viscosupplementation.
  • Data will be collected via questionnaires.
  • For more details on this study visit: http://clinicaltrials.gov/ct2/show/NCT01478386?term=knee+brace+and+viscosupplementation&rank=1
• A Prospective Analysis of Lumbar Spinal Fusions: Instrumentation and Bone Graft Options Evaluating Fusion and Functional Outcomes

  Principal Investigator: Stephen Heim, M.D
  Co-Investigators: Mir Haroon Ali, M.D., Ph.D., John Andreshak, M.D., Jerome Kolavo, M.D.
  Research Coordinator: Marjorie Delaney, APN
  Study Start Date: September 2010
  
  • This study is collecting data on outcomes related to lumbar spinal fusions.
  • Involves creating a data registry dedicated to subjective information related to patients who undergo lumbar fusion surgery.
  

• Patient Reported Outcomes of Surgically Treated Cubital Tunnel Syndrome

  Principal Investigator: Richard Makowiec, M.D.
  Co-Investigators: Anup Bendre, M.D., Thomas Kiesler, M.D., Richard Thomas, M.D., Marjorie Delaney, APN
  Study Start Date: February 2011
  
  • Study consists of the collection and evaluation of data related to two different surgical techniques used in treating cubital tunnel syndrome.

• Insertional Achilles Tendinopathy: A Randomized Trial to Evaluate the Effectiveness of Transferring the Flexor Hallucis Longus Tendon

  
  Principal Investigator: Gregory Witkowski, M.D.
  Co-Investigator: Jeffrey Senall, M.D.
  Research Coordinator: Marjorie Delaney, APN
  Study Start Date: March 2011
  
  • Prospective research study involving patients who are seeking surgical treatment for Achilles tendinopathy.
  • Patients are randomized into two surgical groups and undergo two different surgical procedures (both procedures are currently used in treating Achilles tendinopathy). Post-operative care is identical.
  • Data is collected from patients via questionnaires during pre and post-operative office visits.
  • For more details on this study visit: http://clinicaltrials.gov/ct2/show/NCT01341509?term=achilles+tendinopathy&rank=5

• A Retrospective Study to Evaluate Treatment of Medial and Lateral Epicondylitis with Platelet-Rich Plasma Injection (PRP)

  
  Principal Investigator:Thomas Kiesler, M.D.
  Co-Investigator: Anup Bendre, M.D., Richard Makowiec, M.D., Richard Thomas, M.D., Marjorie Delaney, APN
  Study Start Date: June 2011
  
  • A retrospective study to evaluate the effectiveness of platelet-rich plasma injections for the treatment of lateral and medial epicondylitis.
  • OAD patients who received this injection are being contacted via phone and are being questioned regarding the current condition of the arm that was treated with PRP.
• In 2009, OAD Orthopaedics agreed to participate in a randomized trial with NuVasive, Inc. to evaluate the effectiveness of an artificial cervical disc. NuVasive is a medical device company focused on the design, development, and marketing of products for the surgical treatment of spine disorders.
  

  
  A Pivotal, Multi-Center, Randomized, Controlled Trial Evaluating the Safety and Effectiveness of the NeoDisc versus Instrumented Anterior Cervical Discectomy and Fusion (ACDF) in Subjects with Single-Level Cervical Disc Disease

  
  Participating Surgeons: John Andreshak, M.D., Stephen Heim, M.D.
  Study Start Date: 2009
  Study Close Date: January 2, 2012
  
  • OAD enrolled 11 patients into this clinical trial to evaluate the effectiveness of the NeoDisc. The NeoDisc is an artificial cervical intervertebral disc replacement intended for clinical use following a discectomy.
  • The study is now closed to enrollment. Participants in the study will be followed for a total of 10 years.