ABSTRACT

Introduction: Clinical studies for spinal decompression system DRX9000TM, manufactured by Excite Medical, were conducted in the neurology unit of Municipal Clinical Hospital № 40 between May 13, 2006 and July, 24 2006.

Contests of the ACT: The DRX9000TM was utilized for the treatment of patients with herniated discs L5-S1 (15 patients), L4-15 (4 patients) and L3-14 (2 patients).

Conclusion: The DRX9000TM due to its functionality does not have domestic analogues and considerably exceeds all other devices developed for spinal decompression. The expressed positive clinical effects and tomographic images were demonstrated during treatment of the majority of patients diagnosed with disc herniations at the L5-S1 spinal level. The DRX9000TM spinal decompression system, manufactured by Excite Medical has sustained clinical trials, We have no negative remarks on the DRX9000TM.

Recommendations: Based on the results of clinical trials, the DRX9000TM, manufactured by Excite Medical can be recommended for use in medical practice in the Russian Federation.

INTRODUCTION

• Clinical studies for spinal decompression system DRX9000TM, manufactured by Excite Medical, were conducted in the neurology unit of Municipal Clinical Hospital № 40 between May 13, 2006 and July, 24 2006.
• Objective – evaluate possibilities of using spinal decompression system DRX9000TM, manufactured by Excite Medical in medical institutions in Russian Federation.
• Ground for clinical studies: – Assignment № 294-05/652Φ-06 dated 04/13/06 from Department of registration of foreign medical devices. – Protocol of studies № 574p/37.1 dated 05/03/06 from Testing Center of medical devices ΦΓY “BHИИИMT”.
• The following were present to conduct clinical studies: – Spinal Decompression System DRX9000®. manufactured by Excite Medical USA. – Complete package of the technical documentation and user manual.

CONTESTS OF THE ACT

• DRX9000TM was utilized for the treatment of patients with herniated discs L5-S1 (15 patients), L4-L5 (4 patients) and L3-14 (2 patients).
• There were a total of twenty-one patients. fourteen males and seven females
• Patients ranged in age from twenty-nine to seventy-five years.
• Sixteen of the cases were conducted following the standard six week course of treatment, which was recommended in the user’s manual.
• Five cases were conducted following an individual four week course of treatment due to health improvement and subsequent discharge from the hospital.
• The standard six week course of therapy consisted of five treatments per week for two weeks, three treatments per week for two weeks and two treatments per week for two weeks.
• Twenty treatments were rendered.
• The individual four week course of therapy consisted of five treatments per week for two weeks, three treatments per week for one week and two treatments per week for one week.
• Treatment duration is 35-40 minutes.
• The majority of patients on the first day received an initial decompression treatment set at four kilograms less than half body weight.
• Intensity on the second day of treatment equaled half body weight.
• Increases of two to four kilograms were introduced at each subsequent visit ultimately resulting in an intensity of half body weight plus four to eight kilograms.
• After each treatment, the patient received physiotherapeutic procedures in the form of cold packs and sinusoidal modulated current (80-120 Hz) therapy using system ‘Amonpulse” (“AMΠC”).
• Patients demonstrating positive outcomes after ten treatments were assigned physical therapy as well.

CONCLUSION

RECOMMENDATIONS

Based on the results of clinical trials, the ORX9000TM USA, manufactured by Excite Medical, can be recommended for use in medical practice in the Russian Federation.