GDS Muscle and Articulation Chain Treatment for Chronic LBP and Spinal Stenosis
Low Back PainRecurrent1 moreOur purpose is to conduct a pilot study to evaluate GDS muscle and articulation chain treatment for inoperable spine patients with degenerative changes in the lumbar spine, compared to "standard treatment" (any other chosen treatment). The pilot study will be conducted as a randomized controlled trial (RCT) to investigate feasibility and benefit of GDS muscle and articulation chain treatment on pain, function and quality of life. The pilot study will form the basis for a later full-scale randomized study and the following research questions will be addressed: To what extent were the criteria for inclusion in the study suitable? How did the recruitment procedure work? How did the participants experience GDS treatment? To what extent were the selected outcome measures suitable at the different evaluation moments, and which outcome measure tested in this pilot study would be most suitable as primary outcome measure in a full-scale study? (user experience will be included in the evaluation) How was the change in the primary outcome measure (Oswestry Disability Index)? What will be the estimated time for inclusion of the required number of participants in a full-scale study? (required sample size will be based on strength calculation /saving of the outcome target chosen as primary outcome measure for full scale study) The study is a pilot study with a randomized controlled design, with follow-up after 3-4 months. Thirty patients are recruited and receive baseline examination and respond to the questionnaires before randomization. The patients receive a questionnaire by mail 3-4 months after inclusion (after the treatment is completed for intervention group ). The pilot study will be one-way blinded.
A Zhineng Qigong Intervention for Patients With Chronic Low Back Pain and/or Leg Pain
Chronic Low Back PainChronic Sciatica6 moreThe purpose of this study is to evaluate a Zhineng Qigong intervention for patients with chronic low back pain and/or leg pain, and to test feasibility aspects.
Lumbar Degenerative Disc Disease Treated With Anterior Tension Band System (ATB) With ALIF/FRA Spacer...
Lumbar Degenerative Disc DiseaseMulti-center, prospective nonrandomized study of treatment for 1 and 2 level degenerative disc disease between L2 and S1. Patients will be followed for a minimum of 2 years. The primary objective of this study to measure fusion success in patients with lumbar degenerative disc disease using the ATB and ALIF/FRA Spacer. The Secondary objective is evaluation of the patient's quality of life, pain and function.
Clinical Trial of YH14618 in Patients With Degenerative Disc Disease
Disc Degenerative DiseaseResearch Hypothesis: There will be a greater proportion of VAS responders defined as those who achieve ≥ 50% reduction from baseline in VAS for low back pain at week 12 following intradiscal injection of YH14618 compared to placebo. Patients have been diagnosed as one or two symptomatic lumbar degenerative disc disease defined as Pfirrmann grade 2 to 4 using MRI. Patients have suffered from persistent low back pain with at least 3 months of conservative therapy and must have low back pain measured by VAS≥4 cm and modified Oswestry disability index (mODI) ≥30% at the baseline.
Evaluation of Fusion Rate of Anterior Cervical Discectomy and Fusion (ACDF) Using Cervios ChronOs™...
Intervertebral Disk DegenerationIntervertebral Disk Displacement1 moreAnterior cervical discectomy and fusion (ACDF) has shown good treatment results for a variety of cervical spine diseases such as herniated intervertebral disc (HIVD), cervical spondylotic radiculopathy (CSR) and cervical spondylotic myelopathy (CSM). ACDF using autogenous iliac bone graft is gold standard, however, it may lead to donor-site morbidities. Preventing these complications, some authors have tried to use alterative bone graft substitutes. Among these alternatives, Cervios ChronOs™ which is the polyetheretherketone (PEEK) cage with b-tricalcium phosphate (TCP) has become popular and shown good clinical results. However, b-TCP has only osteoconduction ability of three osteogenic properties. Recently, Bonion™ which is the PEEK cage filled with hydroxyapatite (HA) / demineralized bone matrix (DBM) is introduced. HA/DBM mixture has abilities of osteoconduction and osteoinduction, therefore this alternative is expected to show superior bone fusion capability to PEEK cage with b-TCP. However, there has been no comparison study between the PEEK cage with b-TCP and the PEEK cage with HA/DBM. The purpose of this study is to evaluate bone fusion rate between these cervical spine cages using postoperative computed tomography (CT)
Pilot Study of rhBMP-2/ACS/LT-CAGE® for Anterior Lumbar Interbody Fusion in Patients With Degenerative...
Degeneration of Lumbar Intervertebral DiscThis study is designed to evaluate the feasibility of recombinant human bone morphogenetic protein-2 and absorbable collagen sponge with the tapered interbody fusion device (LT-CAGE® ) for anterior lumbar interbody fusion in patients with degenerative disc disease.
Cellentra Viable Cell Bone Matrix (VCBM) Anterior Cervical Discectomy and Fusion Outcomes Study...
Cervical Disc Degenerative DisorderThe purpose of this study is to assess the clinical and radiographic outcomes in patients who undergo ACDF procedures using Cellentra Viable Cell Bone Matrix (VCBM), cortical allograft spacers, and the MaxAn® Anterior Cervical Plate System. Cellentra VCBM will be compared to published data for autograft in NDI (Neck Disability Index) improvement and radiographic success of fusion.
Interbody Spacers With map3® Cellular Allogeneic Bone Graft in Anterior or Lateral Lumbar Interbody...
SpondylosisSpondylolisthesis1 moreThis is a single-arm post-market study in patients requiring lumbar fusion using allograft interbody spacer in conjunction with map3® Cellular Allogeneic Bone Graft in patients with degenerative disc disease (DDD). This cohort study will enroll 80 patients total at up to 10 sites. After subjects have signed an informed consent, the baseline visit and examinations will be completed. Patients will be evaluated at 6 weeks, 3 months, 6 months, 12 months, and 24 month visit after surgery.
In-house Produced PMMA- Versus PEEK-cages
Cervical Disc DegenerationCervical StenosisSubsidence of cervical cages is a common problem. For the study, a new polyacrylmethacrylate cage was designed and prospectively implanted in patients with a mono- or bilevel cervical pathology. As control, a commercially available PEEK-cage was used, patients were randomized using minimization randomization, controlling for age and bone mineral densitiy. The investigators hypothesize that the newly developed cage has similar clinical and radiological qualities compared to the PEEK-cage, but at a much more favourable cost-performance ratio.
Shaping Anesthetic Techniques to Reduce Post-operative Delirium
DeliriumLumbar Radiculopathy2 moreThe purpose of this study is to determine if light sedation with spinal anesthesia reduces the incidence of delirium compared to receiving general anesthesia during spinal surgery in older adults.