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Clinical study with Spinova Osteo “Our goal is to objectify achievable mobilization”

Issue 01/2019

The spine surgeon Dr. med. Yorck Rommelspacher is among the supervisors involved in a comprehensive study conducted at the University Hospital in Bonn, Germany, concerning the effect of the back orthosis Spinova Osteo1. He cooperates with sports physicians and uses state-of-the-art methods to examine the activity of patients following kyphoplasty.

Dr. med. Yorck Rommelspacher, Senior Physician of the Department of Spine Surgery at the Augustinian Hospital Severins­klösterchen in Cologne.

What is your view of osteoporosis as a surgeon?

Dr. Rommelspacher: It is an ongoing issue. One in two women over 75 is affected. Patients usually don’t come in until it is too late, when they already suffered a fracture. Even minor trauma can lead to a fracture. The likelihood of suffering another fracture is tripled, and after the second fracture it is ten times as high! Despite all this, osteoporosis is under-represented in medicine. We need to raise awareness, we need more networks such as the one in Cologne, and we need more studies carried out at a top scientific level and with a high level of evidence.

You have been measuring and analyzing post-operative movement behavior in 80 osteoporosis patients with and without a back orthosis for a year now. Why?

Dr. Rommelspacher: The comprehensive examination was prompted by a preliminary study2. In this study we were able to show that particular orthoses are able to not only provide stabilization for the patients, but also mobilization. In our current randomized and prospective study we would like to clearly objectify this achievable mobilization based on corresponding parameters. For this purpose we are recruiting patients who have been prescribed a Spinova Osteo following kyphoplasty.

Via the tensioning strap system, the Spinova Osteo guides straightening forces over the shoulders. In the picture: Subject with Jamil Hmida, research staff member at Bonn University Hospital.

What makes kyphoplasty patients stand out?

Dr. Rommelspacher: Kyphoplasty, a minimally invasive procedure for treating vertebral fractures, is in the first place a type of pain therapy. It may also prevent the vertebral body from collapsing further. We generally perform the surgery regardless of the degree of osteoporosis. Although our focus is mostly on providing a non-surgical treatment approach, we are aware of the fact that a certain type of older pain patients tend to benefit to a particularly high degree and particularly quickly from a kyphoplasty. These patients are usually timid and not very mobile, and they also tend to benefit the most from a straightening and stabilizing orthosis.

In what way?

Dr. Rommelspacher: Out study is based on the hypothesis that the Spinova Osteo provides their wearers with a general sense of security. At the same time, the orthosis initiates and encourages mobilization. For osteoporosis patients, in particular those who have suffered recurrent fractures, it is often the case that this aid helps them to find the courage to move again at all – and to do so in a way that allows the muscles and thus the bones to become stronger. This is crucial. It is this process of getting active again that we want to prove. In addition, we’re also looking at whether it could be possible to even achieve additional mobilization in older patients with the Spinova Osteo?

How is it possible to examine this?

Dr. Rommelspacher: We use the “stand-up-and-go test”, for example, to measure the period between getting up and starting to walk. This characteristic start-up period is quite significant. Climbing stairs and geriatric tests are also used to provide information about the degree of mobilization. We use motion trackers on the wrist and pedometers to quantify these parameters. Subjective parameters are also included in the overall assessment , such as answers to specific questionnaires based on established scoring systems.

What are your expectations for the study?

Dr. Rommelspacher: Expectations are rarely useful in scientific work. Based on everything we have seen to date, we work with the hypothesis that the Spinova Osteo promotes mobilization. What is certain, regardless of our results, is that our study will help to increase evidence for the guideline-compliant treatment of osteoporosis patients, which is in desperate need of improvement.

1 Dr. Rommelspacher has been the head of the Department of Spine Surgery at the Augustinian Hospital Severinsklösterchen in Cologne since October 2018. The study is conducted in cooperation with Prof. Dr. med. Robert Pflugmacher, Deputy Director of the Department of Spine Orthopedics at Bonn University Hospital , and Dr. med. Dr. Thomas Hilberg, Head of Sports Medicine at Wuppertal University.
2 Dr. med. Yorck Rommelspacher: Effectiveness of the Spinova Support Plus back orthosis during the postoperative treatment of segmental spondylodeses caused by degenerative conditions of the lumbar spine. Bauerfeind life Magazine, 2/2017.

 

Images: Michael Bause


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