ROBODOC

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ROBODOC is a device for the computer-aided milling and implantation of hip joint prostheses for the treatment of coxarthrosis and other diseases and injuries that require replacement of the hip joint. It was developed and manufactured by the American company Integrated Surgical Systems (ISS), and later further developed and marketed by Curexo Technology, which was renamed THINK Surgical in 2014.

General

The ROBODOC system consists of an adapted industrial robot which , with the aid of a computer, carries out the milling of the bone necessary for the implantation of artificial hip joints. In the conventional method, these millings are made by hand by the operating surgeon with milling devices and files.

With the ROBODOC method, as with the conventional method, all further operational steps before and after the milling process are carried out by hand by the operating surgeon.

For treatment with ROBODOC, detailed and precise planning of the operation is necessary in order to have data on the patient's bone geometry available with sufficient accuracy to control the device. The realism and detail resolution of the imaging process used for planning (e.g. X-ray , computed tomography or magnetic resonance tomography ) is just as important as the experience of the planning surgeon, who has to assign the imaged structures to the structures in the body.

After the system was first tested on dogs in 1990, it was first used in Germany in 1992. For the European market, ROBODOC has been tested for technical safety by TÜV Rheinland in Germany and with this test received Europe-wide approval. In 2008 the system was approved by the FDA in the USA .

Advantages of the operation with ROBODOC

The RoboDoc can (with appropriately precise planning) create millings much more precisely and evenly and match them precisely to the dimensions of the implant. This improves the accuracy of fit and the healing of the prosthesis, which leads to shorter follow-up treatment phases and faster loading of the prosthesis.

Disadvantages and criticisms of the operation with ROBODOC

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After the device was introduced into normal hospital operations, the complication rate was higher than with the conventional method.

The ROBODOC method requires a larger opening in the gluteus middle muscle than the traditional method. This results in permanent damage to the middle and large gluteal muscles and even the associated nerves more often than with the conventional method. Those affected by such damage often have externally visible deep dents in their buttocks.

Inaccuracies in planning before the operation can lead to the control data of the ROBODOC device deviating from reality. This can damage the bone during the operation (e.g. puncture of the lateral bone wall), which the ROBODOC device cannot detect. A human surgeon can often perceive and recognize such deviations from the operation planning during the operation by means of "tactile sensitivity" and adapt the operation at short notice.

Long-term medical studies on the reliability and susceptibility of the ROBODOC method to complications were not necessary for TÜV approval and were not carried out. A study by the medical service of the health insurance companies on behalf of the Barmer Ersatzkasse on the risks of the ROBODOC procedure from 2004 calls into question the reliability and suitability of the procedure and obliges statutory health insurance physicians to expressly point out to patients when providing information before the operation The ROBODOC process is an experimental process that involves higher risks.

On June 13, 2006, the claim for compensation for pain and suffering from a patient who had suffered complications and permanent damage after an operation with the ROBODOC method was rejected by the Federal Court of Justice. This case, however, is not representative of the several hundred victims united in the “Forum ROBODOC” initiative, because according to the court, the damage to this patient was not specific to the ROBODOC procedure. As of October 2006, several dozen lawsuits are pending before various regional courts in Germany, as well as more than 100 evidence proceedings.

See also

literature

Web links

Individual evidence

  1. ↑ Catarina Caetano da Rosa: Surgical Robots in Action: Controversial Innovations in Medical Technology . transcript Verlag, 2014, ISBN 978-3-8394-2165-9 ( google.com ).
  2. ↑ DigiMatch (TM) ROBODOC (R) Surgical System Receives US FDA 510 (k) Marketing Clearance. August 13, 2008, accessed April 3, 2017 .
  3. ↑ BGH, judgment of June 13, 2006 , Az. VI ZR 323/04, full text and BGH, press release No. 89/2006 of June 13, 2006.
  4. ↑ Forum65 , accessed on 23 July 2011th