Active clinical trials for "Intervertebral Disc Degeneration"

This is a prospective, single arm clinical study to evaluate fusion status and patient reported outcomes utilizing the Stryker Tritanium® C Anterior Cervical interbody device at one or two contiguous levels. Subjects that are recommended for surgical treatment of either a 1- or 2-level ACDF (Anterior Cervical Discectomy and Fusion) between the levels of Cervical Spine 2 to Thoracic 1 (C2-T1) and diagnosed with degenerative disc disease will be screened for the study.

A study of the skeletal structure and how the structure changes over time. The aim of the study is to evaluate the skeleton in 10 year increments to determine an understanding of the normal skeleton as a person ages. By using x-ray analysis, a new low dose x-ray system (EOS) can be used to evaluate the whole body to see changes in the bone structure over time. Subjects will be asked to undertake one x-ray analysis of their whole body skeletal structure. There will be 25 male and 25 female subjects per decade. The averaging of the measured skeletal parameters will provide information on changes over time generating a standardized expectation of general changes in skeletal structure as participants age.

The aim of this study is to prospectively investigate the potential for bony fusion of ViviGen® bone graft substitute in comparison to rhBMP-2 in standalone ALIF procedure L5/S1

This single-institution prospective case series (single arm) study will assess the clinical outcomes of patients diagnosed with 1 or 2 level level discogenic low back pain following an intradiscal injection of bone marrow aspirate concentrate (BMAC).

Lumbar spinal stenosis (LSS), is a common disorder of narrowing of the spinal canal in the lower part of the back. This causes discomfort in the legs when standing or walking because of pressure on the spinal nerves.There are several treatment options for LSS including physiotherapy, lumbar surgical decompression procedures such as laminectomy, Foraminotomy, Discectomy and more recently devices for interspinous distraction such as the XSTOP® and from May 2011 Minuteman™. Surgical decompression for LSS involves the removal of excess bone, ligament, and soft-tissue allowing more room for the nerves. The operation is usually preformed under general anaesthetic and with an average stay in hospital for 2-3 nights. Whereas the Minuteman™ implant is preformed as a day case under local or general anaesthetic and involves implanting the device into the space between two back bones to relieve pressure on the nerves and, therefore, pain in the legs. This is a multi centred (four sites) randomised controlled trial with a total sample of 50 participants after obtaining their informed consent. Participants will attend the pain clinic at the Hospitals for a baseline visit where they will be randomised with a ratio of 1:1 to receive either the Minuteman™ Interspinous interlaminar fusion Implant or standard surgical decompression for the treatment of lumbar spinal stenosis (LSS). Following randomisation arrangements will be made for the participant to receive the randomised treatment. If allocated to Minuteman™ Implant, the treatment will be conducted by the Pain Specialist identified at the site. If allocated to surgical decompression, the treatment will be conducted by the neuro/spinal-surgeon identified at the site. Participates will be followed up regularly for 60 months post implant to assess clinical efficacy, safety, participants function and quality of life of each treatment.

This is a phase IV post-marketing study for MagnetOs Putty. MagnetOs Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with leg pain and/or back pain and undergoing spinal fusion surgery. In this study, MagnetOs Putty will be used according to the latest U.S. Instructions For Use, specifically as a bone graft extender mixed with autograft in a 1:1 vol.% in the posterolateral spine.

Tranexamic acid and placebo will be given during surgery to patients who have elected to undergo lumber interbody fusion on 2 or more levels. Information regarding blood loss, transfusions needed, postoperative cognitive status (including delirium), postoperative markers of systemic inflammation and duration of hospital stay will be collected.

This will be a multicenter, prospective, double blind, randomized phase 2/3 trial comparing culture-expanded allogeneic adult BM-MSCs with sham-treated controls. This trial will evaluate the efficacy of intradiscal injection of BM-MSCs in chronic low back pain due to lumbar degenerative disc disease (DDD) unresponsive to conventional therapy . Visual analog scale (VAS) and functional status (by Oswestry Disability Index - ODI) will be evaluated 12 months after treatment, defining responders in case of improvement of VAS for pain of at least 20% and 20 mm between baseline and month 12, or improvement of ODI of 20% between baseline and month 12.

Motor Evoked Potentials are an aspect of intraoperative neuromonitoring, a tool used by neurophysiologists during surgery to prevent irreversible damage to the spinal cord during procedures. This study investigates the utility of three separate quadriceps MEP recording approaches over a total of 40 limbs (20 participants).

The aim of this trial is to evaluate if P-15L bone graft (investigational device) is not inferior in effectiveness and safety to local autologous bone (and allograft where necessary) as an extender (control device) when applied in instrumented transforaminal lumbar interbody fusion (TLIF) in subjects with degenerative disc disease (DDD). In addition to the general overall objective, a sub-group analysis will be performed on the high-risk subject population (tobacco use, obesity, diabetes), as previous studies have shown negative effects of smoking, obesity and diabetes on fusion and bone healing, increased peri/postoperative complications, and lower patient-reported outcome scores.