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Home/Spine/SpineMark, RNOH Partner for Research
Spine

SpineMark, RNOH Partner for Research

April 19, 2013 2 min read Premium comments

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SpineMark, RNOH Partner for Research
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The Royal National Orthopaedic Hospital (RNOH), the largest musculoskeletal orthopedic hospital in the United Kingdom, and U.S.-based SpineMark Corporation, have announced a joint agreement to develop a spine research unit within RNOH called Spinal Research Stanmore (SRS).

RNOH will provide administrative support and clinicians to meet the demands of industry and internal study goals including recruiting patients and investigators. RNOH and SpineMark will seamlessly oversee clinical trials and management of the unit. SpineMark will provide the development, marketing, governance, contracting, oversight, physician peer mentoring—provided by its medical advisory board OrbiSpine—and support for SRS, including any necessary training for new spine-dedicated clinical research coordinators and staff associated with the unit.

The short-term SRS objectives include significant research growth in the unit by supporting sponsor initiated clinical and post market studies as well as the creation of SRS retrospective and prospective study groups to evaluate key trends, techniques, outcomes and diagnostic data from RNOH patients.

“RNOH has demonstrated an impressive commitment to spinal clinical research and SpineMark is pleased to serve as its partner through the establishment of SRS, ” said Marcy Rogers, SpineMark president and CEO, in the April 15 news release. “We expect our spine research model to serve as a significant driver of growth for the unit.”

Asked what things had to come together in order for this partnership to come to fruition, Rogers told OTW, “Timing is everything! The RNOH had been actively looking for a vehicle to create a more formalized program in spinal clinical research that had the full consent and participation of its 12 spinal consultants. SpineMark brings extensive experience in supporting physicians and facilities to develop dedicated spinal clinical research programs. Recruiting Dr. Behrooz Akbarnia to serve as a consultant to SRS to oversee internal research activities, administration, coordinator training and study design has been a very significant asset to the partnership. Putting together the governance model, infrastructure, protocols for industry and internal studies and administration of SRS led to consensus and alignment of goals and objectives. Post our feasibility study in September of 2012, we received approval from appropriate parties within the NHS System as well as at RNOH. Since then it’s been in full operation mode and I am pleased to say we already have our first study with others pending.”

Asked where they hope to be in one year in terms of research, growth, etc., Rogers added, “We have set measurable goals for this year; they include participation in 15-20 sponsor studies, completion of internal prospective and retrospective review studies for publication and presentation at specialty societies, and meeting financial, management and operational benchmarks. The UK has gone through tremendous change relative to research studies. Everything has been converted to an electronic data system which has streamlined the study approval process so that it’s now possible to go from Ethics Committee submission to site initiation in four to six weeks.”

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Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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