CLINICAL RESEARCH DEPARTMENT
In 2010, OAD Orthopaedics created a Clinical Research Department to further its 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, we are involved in the following investigator-initiated studies (i.e., research OAD developed):
Radiostereometric Analysis (RSA) of Spine Arthrodesis
Principal Investigator: John Andreshak, M.D.
Co-Investigators: Stephen Heim, M.D., Jerome Kolavo, M.D.
Study Start Date: December 1, 2012
• A prospective research study to evaluate relative intervertebral motion for lumbar spinal fusion patients, using radiostereometric analysis (RSA).
• 250 Patients will be implanted with 1mm tantalum marker beads at the time of spinal fusion surgery.
• From the 250 patients that are marked with tantalum beads, three study groups will be formed. The three groups are as follows:
1) Clinically fused per radiographic assessment
2) Definitive clinical evidence of no fusion and are scheduled for revision surgery
Definitive clinical evidence of no fusion and are not scheduled for revision surgery
• Beginning at the 6 month follow-up exam, the first ten consecutive patients that meet the definition of each of the three groups will undergo a radiostereometric analysis (RSA) evaluation, there will be 30 total patients; 10 in each group.
Indwelling Interscalene Nerve Catheters in Surgical Management of Idiopathic Adhesive Capsulitis
Aaron Bare, M.D.
John Boudeman, M.D., Paul Hawkins, M.D., Marjorie Delaney, APN, Maggie Ranum, ATC
Study Start Date:
June 11, 2012
Prospective research study comparing two types of anesthesia for patients undergoing shoulder manipulation for adhesive capsulitis (frozen shoulder).
Patients will be randomized into one of two study groups and each group will receive a different method of shoulder anesthesia; post-operative care will be identical in both groups.
Data will be collected pre, intra and post-operatively.
For more details on this study visit: http://clinicaltrials.gov/ct2/show/NCT01606332?term=frozen+shoulder&rank=16
Foot Pronation and Greater Trochanteric Hip Pain: A Correlational Pilot Study
Principal Investigator: Beth Froese, M.D.
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 Medial Knee Osteoarthritis
William Sterba, M.D.
David Chang, M.D., David Mochel, M.D., Marjorie Delaney, APN
Study Start Date:
Study will document the efficacy of two common treatments for mild to moderate medial 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: 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.
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.
Nurse Practitioner &
Marjorie Delaney, APN - FNP/BC