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Stenoses, Spinal clinical trials

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NCT ID: NCT05035693 Recruiting - Radiculopathy Clinical Trials

Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C

PMCF_MOVE®-C
Start date: March 11, 2021
Phase: N/A
Study type: Interventional

Study design: International, prospective, multicentre, non-randomised, observational study according to § 23b MPG. Objectives: Observational study to confirm the safety and performance of the cervical disc prosthesis MOVE®-C.

NCT ID: NCT03480893 Recruiting - Stenoses, Spinal Clinical Trials

Cost-effectiveness of Small Size Interarcuair Decompression Versus Extended Decompression in Patients With Intermittent Neurogenic Claudication

Size
Start date: March 1, 2020
Phase: N/A
Study type: Interventional

Rationale: Minimally invasive techniques have gained popularity to decompress lumbar spinal stenosis in the elderly. However, high quality evidence based on randomised controlled trials are not available. Objective: To investigate whether small size interarcuair decompression is more effective than conventional laminectomy in patients with intermittent neurogenic claudication caused by lumbar spinal stenosis. Study design: Double-blinded multi-centre randomised controlled trial Study population: In total 236 patients are to be included. The inclusion criteria are: subjects > 40 years of age with at least 12 weeks of complaints of intermittent neurogenic claudication based on MRI confirmed of LSS, with sufficient knowledge of the Dutch language. Intervention: Small size interarcuair decompression versus conventional laminectomy. Main study parameters/endpoints: Primary outcome is the Modified Roland Morris Questionnaire. Secondary outcomes are leg pain, back pain and a 6 minute walk test amongst others. Nature and extent of the burden and risks associated with participation: based on available literature , it is believed that the risks associated with small size interarcuair decompression are no greater than that associated with a laminectomy, although these will be examined.