Alternative Dorsal Root Ganglion Neuromodulation Electrode Implantation: A Report of 2 Cases with 3 Different Techniques.

BACKGROUND AND STUDY AIMS: The traditional percutaneous placement of dorsal root ganglion (DRG) electrodes may not be eligible for every patient. In this tertiary spine surgery and interventional pain therapy center, alternative neurostimulation implantation techniques were developed and applied where standard percutaneous approaches failed or were contraindicated. CASE PRESENTATION: Three alternative implantation techniques can be used: (1) open surgical placement of DRG leads, (2) two-lead insertion via a lateral to medial transforaminal approach (level L3), and (3) percutaneous approach with two leads close to the spinal nerves L4 (peripheral nerve stimulation). RESULTS: The placement of the leads occurred without complications and resulted in similar expected outcomes as with the common percutaneous technique with long-term stable pain suppression at 7 months and 1 year. CONCLUSIONS: In patients in whom the DRG cannot be approached by the standard percutaneous approach, at least three alternatives may be used in experienced hands resulting in stable pain suppression of similar magnitude.

The Impact of Dorsal Root Ganglion Stimulation on Pain Levels and Functionality in Patients With Chronic Postsurgical Knee Pain.

BACKGROUND: Chronic postsurgical pain is a considerable source of disabling neuropathic pain. Rates of knee replacement surgeries are increasing, and many patients report chronic postsurgical pain in their wake. When conventional therapies prove ineffective, neuromodulation options such as dorsal root ganglion stimulation (DRGS) may be used. However, little is known about the effect of DRGS on improvements in quantitative functional outcome parameters. MATERIALS AND METHODS: In a prospective observational study at two pain centers, patients with chronic postsurgical knee pain underwent implantation with a DRGS system after an interdisciplinary multimodal pain program. Ratings of pain, mood, quality of life, and function were captured at baseline and through 12 months of treatment. Quantitative measures (range of motion, walking distance, and pain medication usage) were also recorded. RESULTS: Visual analog scale ratings of pain decreased from 8.6 to 3.0 (p < 0.0001; N = 11), and other pain measures agreed. Quality of life on the 36-Item Short Form Health Survey questionnaire improved from 69.3 to 87.6 (p < 0.0001), whereas the improvement in depression ratings was nonsignificant. International Knee Documentation Committee questionnaire ratings of function improved from 27.7 to 51.7 (p < 0.0001), which aligned with other functional measures. On average, knee range of motion improved by 24.5°, and walking distance dramatically increased from 125 meters to 1481. Cessation of opioids, antidepressants, and/or anticonvulsants was achieved by 73% of participants. CONCLUSIONS: Both subjective-based questionnaire and quantitative examination-based variables were in broad agreement on the value of DRGS in improving functionality and chronic postsurgical pain in the knee. Although this finding is limited by the small sample size, this intervention may have utility in the many cases in which pain becomes problematic after orthopedic knee surgery.

A prospective, international, randomized, noninferiority study comparing an implantable titanium vertebral augmentation device versus balloon kyphoplasty in the reduction of vertebral compression fractures (SAKOS study).

BACKGROUND CONTEXT: Balloon kyphoplasty (BKP) is a commonly performed vertebral augmentation procedure for painful osteoporotic vertebral compression fractures (OVCFs). OBJECTIVE: This study aimed to support a non-inferiority finding for the use of a titanium implantable vertebral augmentation device (TIVAD) compared to BKP. STUDY DESIGN: Prospective, parallel group, controlled comparative randomized study. PATIENT SAMPLE: Patients who presented with one or two painful OVCFs located between T7 and L4 aged <3 months, failed conservative treatment, and had an Oswestry Disability Index (ODI) score ≥30/100 were eligible for the study. OUTCOME MEASURES: The primary composite endpoint was defined as: reduction in VCF fracture-related pain at 12 months from baseline and maintenance or functional improvement (ODI) at 12 months from baseline, and absence of device-related adverse event or surgical reintervention. If the primary composite endpoint was successful, a fourth component (absence of adjacent level fracture) was added for analysis. If the analysis of this additional composite endpoint was successful, then midline target height restoration at 6 and 12 months was assessed. Secondary clinical outcomes included back pain intensity, ODI score, EQ-5D index score (range 0=death to 1=full health) and EQ-VAS score (range 0-100). METHODS: Patients were recruited in 13 hospitals across 5 countries and were randomly assigned (1:1) to either TIVAD or BKP with electronic randomization as described in the protocol. A total of 152 patients with OVCFs were initially randomized. Eleven patients were excluded (six met exclusion criteria, one with evidence of tumor, and four patients had T score out of requested range). Anterior vertebral body height ratio, midline vertebral body height ratio, and Cobb angle were measured preoperatively and postoperatively by an independent imaging core lab. Adjacent and subsequent fractures and safety parameters were recorded throughout the study. Cement extravasation was evaluated on X-rays. All patients were followed at screening at 5 days, 1 month, 6 months, and 12 months postoperatively. This study was supported by Vexim SA. Seven authors received study-specific support less than $10,000 per year and seven authors received no study-specific support. RESULTS: Among the 141 patients (78.7% female, mean age 73.3±9.5 years) who underwent surgery (TIVAD=68; BKP=73), 126 patients (89.4%) completed the 12-month follow-up period (TIVAD=61; BKP=65). The analysis of primary endpoint on the ITT population demonstrated non-inferiority of the TIVAD to BKP. The analysis of the additional composite endpoint demonstrated the superiority of TIVAD over BKP (p<0.0001) at 6 months (88.1% vs. 60.9%) and at 12 months (79.7% vs. 59.3%). Midline VB height restoration was more improved for TIVAD than for BKP at 6 months (1.14±2.61 mm vs. 0.31±2.22 mm); p=0.0246) and 12 months after surgery (1.31±2.58 mm vs. 0.10±2.34 mm; p=0.0035). No statistically significant differences were shown between procedures for improvement in functional capacity and quality of life. Pain relief was significantly more marked in the TIVAD group compared to the BKP group at 1 month (p=0.029) and at 6 months (p=0.021) after surgery. No patient required surgical reintervention or retreatment at the treated level. No symptomatic cement leakage was reported. Adverse events were similar for both groups (41.2% in the TIVAD group and 45.2% in the BKP group). The incidence of adjacent fractures was significantly lower after the TIVAD procedure than after BKP (12.9% vs. 27.3%; p=0.043). CONCLUSIONS: Study results demonstrated non-inferiority of the TIVAD to the predicate BKP with an excellent risk/benefit profile for results up to 12 months.

Complication of a closed Colles-fracture: necrotising fasciitis with lethal outcome. A case report.

We report a case of a 77-year-old female patient who died 4 days after a closed colles-fracture of the right wrist because of secondary emerged necrotising fasciitis. At the time of visiting our emergency department, the patient reports about untypical pain and progressive swelling of the entire right arm 3 days following a fall onto the outstretched hand where she sustained a closed distal radius fracture. Within 6 h, the patient developed hypotension and fever leading to cardiac and respiratory failure. The emergent-induced diagnostic presented a severe septic situation in the laboratory examination of the blood samples, an apparent before unknown diabetes mellitus and an unknown bronchial carcinoma with part of post-stenosis pneumonia of the right lung. After initial CPR and stabilisation, the patient underwent an urgent and aggressive surgical debridement with fasciotomies of the muscle compartments of the entire right upper extremity. The microbiological investigation of the intraoperative taken specimens presented plentiful group-A-beta-haemolytic streptococcus. Despite a broad spectrum intravenous antibiotic therapy, intensive care support and a second look operation 12 h later with exarticulation of the right arm in the shoulder joint, the patient died of septic shock and multiorgan failure 34 h after admission.