Autologous bone marrow concentrate intradiscal injection for the treatment of degenerative disc disease with three-year follow-up.

Purpose: The purpose of this study is to assess safety and feasibility of intradiscal bone marrow concentrate (BMC) injections to treat low back discogenic pain as an alternative to surgery with three year minimum follow-up.

Methods: A total of 26 patients suffering from degenerative disc disease and candidates for spinal fusion or total disc replacement surgery were injected with 2 ml autologous BMC into the nucleus pulposus of treated lumbar discs. A sample aliquot of BMC was characterized by flow cytometry and CFU-F assay to determine progenitor cell content.

Why Lumbar Artificial Disk Replacements (LADRs) Fail.

Study Design: A retrospective review of prospectively collected data.

Objective: To determine why artificial disk replacements (ADRs) fail by examining results of 91 patients in FDA studies performed at a single investigational device exemption (IDE) site with minimum 2-year follow-up.

Summary Of Background Data: Patients following lumbar ADR generally achieve their 24-month follow-up results at 3 months postoperatively.

Five-Year Follow-Up of a Prospective, Randomized Trial Comparing Two Lumbar Total Disc Replacements.

Study Design: This was a prospective, randomized, controlled, multicenter study.

Objective: The purpose of this study was to compare outcomes of two lumbar total disc replacements (TDRs) at 5-year follow-up and report results of serum ion level analysis in a subgroup of patients receiving a metal-on-metal implant.

Summary Of Background Data: Lumbar TDR has been compared with fusion in several randomized studies, finding TDR noninferior to fusion and superior on some measures.

Treatment of discogenic back pain with autologous bone marrow concentrate injection with minimum two year follow-up.

Purpose: The purpose of this study is to assess safety and feasibility of intradiscal bone marrow concentrate (BMC) injections to treat discogenic pain as an alternative to surgery.

Methods: A total of 26 patients (11 male, 15 female, aged 18-61 years, 13 single level, 13 two level) that met inclusion criteria of chronic (> 6 months) discogenic low back pain, degenerative disc pathology assessed by magnetic resonance imaging (MRI) with modified Pfirrmann grade of IV-VII at one or two levels, candidate for surgical intervention (failed conservative treatment and radiologic findings) and a visual analogue scale (VAS) pain score of 40 mm or more at initial visit. Initial Oswestry Disability Index (ODI) and VAS pain score average was 56.

Percutaneous injection of autologous bone marrow concentrate cells significantly reduces lumbar discogenic pain through 12 months.

Degenerative disc disease (DDD) induces chronic back pain with limited nonsurgical options. In this open label pilot study, 26 patients (median age 40 years; range 18-61) received autologous bone marrow concentrate (BMC) disc injections (13 one level, 13 two levels). Pretreatment Oswestry disability index (ODI) and visual analog scale (VAS) were performed to establish baseline pain scores (average 56.

Comparison of 2 lumbar total disc replacements: results of a prospective, randomized, controlled, multicenter Food and Drug Administration trial with 24-month follow-up.

Study Design: This was a prospective, randomized, controlled multicenter study with 24-month follow-up.

Objective: The purpose of this study was to evaluate the safety and efficacy in a Food and Drug Administration Investigation Device Exemption of a new lumbar total disc replacement (TDR) by comparing it to an earlier TDR approved for sale.

Summary Of Background Data: Randomized trials have reported TDR to produce results similar or superior to lumbar fusion.

Prospective study of disc repair with allogeneic chondrocytes presented at the 2012 Joint Spine Section Meeting.

Object: The purpose of the study was to evaluate the safety and initial efficacy of NuQu allogeneic juvenile chondrocytes delivered percutaneously for the treatment of lumbar spondylosis with mechanical low-back pain (LBP). NuQu is a cell-based biological therapy for disc repair. The authors report the results at 12 months of the NuQu Phase I investigational new drug (IND) single-arm, prospective feasibility study for the treatment of LBP for single-level degenerative disc disease (Pfirrman Grades III-IV) at L3-S1.

Kineflex lumbar artificial disc versus Charité lumbar total disc replacement for the treatment of degenerative disc disease: A randomized non-inferiority trial with minimum of 2 years' follow-up.

Background: The Kineflex lumbar artificial disc replacement device (SpinalMotion, Mountain View, California) is a semiconstrained, posterior center of rotation, metal-on-metal intervertebral disc prosthesis. We performed a prospective, randomized, non-inferiority trial comparing the Kineflex Disc with the Food and Drug Administration (FDA)-approved Charité device (DePuy Spine, Raynham, Massachusetts). Our objective was to evaluate the Kineflex Disc's safety and efficacy using validated outcomes measures-the visual analog scale (VAS) and the Oswestry Disability Index (ODI).