NHS Randomised Clinical Trial
Whilst the prospective outcome and morbidity studies of Endoscopic Lumbar Decompression and Foraminoplasty have proved very encouraging it has not been subjected to a randomised controlled clinical trial to fully establish the evidence base for the procedure. Whilst National Institute for Clinical Excellence and Health guidelines confirm that most patients are improved by the use of the technique, this organisation requires this base before the technique can be widely disseminated through the NHS.
Consequently a pilot study has been drawn up to test the ability to recruit patients to the study and to evaluate a sample series to establish the required size of a full comparative study. The study will focus upon the reduction of back pain, referred pain, complications and cost when compared to fusion. The closest open technique to Endoscopic Lumbar Decompression and Foraminoplasty is Transforaminal Lumbar Interbody Fusion. Patients will be randomised to either treatment.
In order to expedite recruitment the study will be carried out in the Huddersfield Nuffield Hospital and in the Wooridul Hospital Seoul, Korea.
This study is being designed and monitored with the help of the York Clinical Trials Unit
The study is entitled "An international pragmatic multi-centre randomised trial of Endoscopic Lumbar Decompression and Foraminoplasty versus Transforaminal Lumbar Interbody Fusion in the treatment of back pain: an effectiveness & economics pilot study"
- Objectives
Objectives - Outcomes to be measured
Outcomes to be measured - Study Summary
Study Summary - Summary of Current Evidence
Summary of Current Evidence - The Research Team
Research Team - Trial Design
Randomised Controlled Clinical Trial Design - Who Should be Referred?
Who Should be Referred?
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