Risks of Intradiscal Orthobiologic Injections: A Review of the Literature and Case Series Presentation.

BACKGROUND: Intervertebral disc disease (IDD) is responsible for a large portion of back pain with historically suboptimal treatments for long-term improvement. IDD pathogenesis is thought to arise at a cellular and biochemical level, making biologically based injections an area of clinical interest. Although human studies have shown promise, emerging data suggest there may be risks inherent to such injections that were previously unrecognized. The aim of this review is to summarize the known risks to date and provide mitigation steps to reduce potential complications in the future. In addition, we present a small case series of serious adverse events (SAEs) from our clinical practice. METHODS: A literature review was performed to identify human intradiscal autologous biologic injection studies to date, including mesenchymal signaling cells (MSCs) and platelet-rich plasma (PRP) preparations, which were reviewed for complications. Cases of complication following intradiscal orthobiologic injection were identified from a single outpatient center and reviewed. RESULTS: Publications of MSC-based intradiscal injection documented 136 total patients treated with two SAEs reported, one infection and one progressive disc herniation. Publications of PRP intradiscal injection included 194 patients with one SAE reported. We also review three cases of previously unpublished SAEs, including one case of confirmed infection with Cutibacterium acnes (C acnes) and two presumed cases of discitis without pathogen confirmation. Bone marrow concentrate was the injectate in all three cases. CONCLUSIONS: Although biologic intradiscal injection shows promise for the treatment of discogenic back pain, there are inherent risks to be considered and mitigated. We currently recommend a leukocyte-rich PRP and a two-needle delivery technique coupled with intradiscal gentamicin to mitigate the risk of postinjection spondylodiscitis. Further research is needed using large registries to not only track clinical outcomes but also complication rates.

A retrospective analysis of a commercially available platelet-rich plasma kit during clinical use.

INTRODUCTION: Point-of-care analyses of platelet-rich plasma (PRP) are not routine in the orthopedic regenerative medicine field. Therefore, many physicians rely on the manufacturer's reported content for commercial preparation kits. This contributes to a knowledge gap between injectate content and patient outcome. OBJECTIVE: To assess whether the EmCyte PurePRP II 60-mL preparation kit returns PRP content that meets the manufacturer's expectations when used during routine clinical care for a heterogenous patient population, and to determine whether a change in PRP yield volume affects injectate content. Protocol A (exclusion of granulocytes and low hematocrit) and Protocol B (inclusion of granulocytes and higher hematocrit) were evaluated. DESIGN: Retrospective review. SETTING: Private practice. PARTICIPANTS: One hundred five patients (118 preparations) treated for orthopedic conditions over an 8-month period via PRP injection. Thirteen patients had two independently made preparations on different treatment days that qualified for analysis. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Complete blood count (absolute counts and calculated fold enrichment from baseline of platelets, white blood cells, red blood cells, granulocytes, lymphocytes, monocytes; and hematocrit levels). Confounding variables included age, gender, and preparation yield volume. RESULTS: During routine clinical use, the cellular content of both Protocols A and B met or exceeded the manufacturer's expectations of platelet enrichment and granulocyte inclusion or exclusion. Hematocrit values were slightly higher than anticipated from Protocol A preparations. The modification of yield volume from 7 to 4 mL led to a significant difference in platelet enrichment without affecting absolute cell counts (2.88; 95% confidence interval [CI] 1, 4.76; P = .003). Both gender and age moderately affected the level of platelet enrichment from baseline but did not significantly affect absolute platelet counts. CONCLUSION: In the absence of widespread characterization, confirming the variation in commercial PRP kits during clinical use is crucial.

Treatment of symptomatic degenerative intervertebral discs with autologous platelet-rich plasma: follow-up at 5-9 years.

Aim: This study assessed pain and function at 5-9 years postinjection in a subset of patients who received intradiscal platelet-rich plasma (PRP) injections for moderate-to-severe lumbar discogenic pain. Patients & methods: All patients received injections of intradiscal PRP in a previous randomized controlled trial. Data on pain, function, satisfaction, and need for surgery were collected at one time point of 5-9 years postinjection and compiled with existing data. Results: In comparison to baseline, there were statistically significant improvements in pain and function (p < 0.001). All improvements were clinically significant. Six patients had undergone surgery during the follow-up period. Conclusion: This subset of patients demonstrated statistically and clinically significant improvements in pain and function at 5-9 years postinjection.

Percutaneous Rupture of Zygapophyseal Joint Synovial Cysts: A Prospective Assessment of Nonsurgical Management.

BACKGROUND: Although lumbar zygapophyseal joint synovial cysts are fairly well recognized, they are an uncommon cause of lumbosacral radicular pain. Nonoperative treatments include percutaneous aspiration of the cysts under computed tomography or fluoroscopic guidance with a subsequent corticosteroid injection. However, there are mixed results in terms of long-term outcomes and cyst reoccurrence. This study prospectively evaluates percutaneous ruptures of zygapophyseal joint (Z-joint) synovial cysts for the treatment of lumbosacral radicular pain. OBJECTIVES: Primary: To determine whether percutaneous rupture of symptomatic Z-joint synovial cysts leads to sustained improvements in radicular pain and function. Secondary: To assess the rates of cyst recurrence and progression to surgical intervention following percutaneous rupture of symptomatic Z-joint synovial cysts. DESIGN: Prospective cohort study. SETTING: Outpatient academic spine practice. PARTICIPANTS: Adults with primary radicular pain due to a facet synovial cyst. METHODS: Participants underwent fluoroscopically guided percutaneous Z-joint synovial cyst ruptures under standard-of-care practice. Data on pain, physical function, satisfaction, and progression to surgery were collected at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after rupture. An intention-to-treat analysis was used for assessment of patient-reported outcome measures. MAIN OUTCOME MEASURES: The Numerical Rating Scale, Oswestry Disability Index, and modified North American Spine Society questionnaires were used to measure pain, function, and satisfaction with the procedure, respectively. RESULTS: Thirty-five participants were included in the study, and data were analyzed by an independent researcher. Statistically significant changes in Oswestry Disability Index were reported at 2 weeks, 3 months, and 1 year postintervention (P = .034, .040, and .039, respectively). A statistically and clinically significant relief of current pain was reported at 2 weeks (P = .025) and 6 weeks (P = .014) with respect to baseline. Patients showed significant improvements for best pain at 6 weeks with respect to baseline (P = .031). Patients' worst pain showed the greatest amount of improvement with clinically meaningful changes at all time points compared with baseline. Patient-reported satisfaction was found nearly 70% of the time at all time points. Forty percent (14/35) of participants required repeat cyst rupture, and 31% (11/35) required surgical interventions. CONCLUSIONS: There were statistically and clinically significant improvements in pain and function after percutaneous rupture of Z-joint synovial cysts. In addition, the outcomes support previous retrospective studies indicating that approximately 40% of patients will need surgery. This study provides further research to determine the utility of this procedure and to precisely define a subset of ideal candidates. LEVEL OF EVIDENCE: Level II.

Percutaneous intradiscal aspiration of a lumbar vacuum disc herniation: a case report.

We report a case of an 83-year-old gentleman presenting with acute low back pain and radicular left lower extremity pain after golfing. A magnetic resonance imaging (MRI) of the lumbar spine revealed a low-signal-density lesion compressing the L5 nerve. A computed tomography scan was then ordered, confirming an extra-foraminal disc protrusion at the L5-S1 level, containing a focus of gas that was compressing the left L5 nerve root and communicating with the vacuum disc at L5-S1. After a failed left L5 transforaminal epidural steroid injection, the patient was brought back for a percutaneous intradiscal aspiration of the vacuum disc gas. This resulted in immediate relief for the patient. A follow-up MRI performed 2 months after the procedure found an approximate 25% reduction in the size of the vacuum disc herniation. Six months after the procedure, the patient remains free of radicular pain. This case report suggests that a percutaneous aspiration of gas from a vacuum disc herniation may assist in the treatment of radicular pain.

Synovial cysts: to fuse or not to fuse?

COMMENTARY ON: Bydon A, Xu R, Parker SL, et al. Recurrent back and leg pain and cyst reformation after surgical resection of spinal synovial cysts: systemic review of reported postoperative outcomes. Spine J 2010;10:820-826 (in this issue).

Fluoroscopic percutaneous lumbar zygapophyseal joint cyst rupture: a clinical outcome study.

BACKGROUND CONTEXT: Lumbar zygapophyseal joint (Z-joint) synovial cysts can cause low back pain (LBP), spinal stenosis, and lower extremity radiculopathy. In the literature, there are several minimally invasive techniques described with mixed results. Typical recommended treatment is surgical resection of the cyst. Currently, there is little information available concerning the efficacy and outcome with treatment of Z-joint synovial cyst by percutaneous, fluoroscopic, contrast-enhanced distention, and rupture. PURPOSE: To evaluate the therapeutic value and safety of Z-joint cyst rupture in symptomatic patients. STUDY DESIGN/SETTING: Retrospective cohort study in an academic outpatient physiatric spine practice. PATIENT SAMPLE: Thirty-two patients with moderate-to-severe LBP and leg pain (18 women and 14 men with an age range of 46-86 y; mean age, 66 y) with an average preprocedure symptom duration of 5 months. The patient's clinical symptoms correlated with magnetic resonance imaging studies documenting the presence of a synovial cyst at the corresponding level and side of symptoms. Patients had at least 6 months follow-up (range, 6-24). OUTCOME MEASURES: Numerical Pain Rating Scale, Roland-Morris Disability Questionnaire, North American Spine Society four-point patient satisfaction survey, recurrence of synovial cyst requiring repeat rupture, and need for surgical intervention. METHODS: Patients with symptomatic lumbar Z-joint synovial cyst were identified and their charts were reviewed. Patients included in the study either had symptomatic lumbar LBP or LBP with associated lower extremity radiculopathy. All patients in the study had magnetic resonance imaging's documenting Z-joint synovial cyst that corresponded with the patients' clinical symptoms. All patients received fluoroscopically guided, contrast-enhanced, percutaneous facet cyst distention and rupture followed by an intra-articular facet joint injection of 1 cc kenalog and 1 cc of 1% lidocaine. Seventeen of the patients also received a transforaminal epidural steroid injection just before facet cyst rupture. Telephone follow-up was conducted on all patients. RESULTS: Excellent long-term (average follow-up 1 y; range, 6-24 mo) pain relief was achieved in 23 (72%) of 32 patients undergoing facet cyst rupture. Twelve patients (37.5%) had synovial cyst recurrence and 11 chose to undergo repeat rupture, which resulted in 5 patients (45%) obtaining complete relief of symptoms and 6 patients (55%) requiring surgical intervention for cyst removal. Fisher exact test demonstrated that all patients who did not have a cyst recurrence were a success and obtained complete relief of symptoms (p<.0002). Patients who underwent a repeat rupture had a 50% chance of a successful outcome. There was no statistical significance between a successful outcome and level of facet cyst rupture, the presence of spondylolisthesis, sex, age, or having a transforaminal epidural steroid injection at the time of the procedure. Wilcoxon signed-rank test demonstrated that the difference in Numerical Pain Rating Scale and Roland-Morris Disability Questionnaire scores before and after the procedure was statistically significant (p<.0001). No complications were reported. CONCLUSIONS: Fluoroscopic percutaneous Z-joint cyst rupture appears to be a safe and effective minimally invasive treatment option. This procedure should be considered before surgical intervention.

Lumbar zygapophysial joint radiofrequency denervation: a long-term clinical outcome study.

Zygapophysial joint (z-joint) pain has long been suggested to be one of the sources of low back pain. Radiofrequency denervation of the medial branches of the dorsal rami to treat z-joint pain is an outpatient minimally invasive treatment option. There have been many short-term studies to determine the outcome of the procedure, but few long-term studies have been conducted. Our goal is to clarify whether radiofrequency denervation has any long-term clinical benefit. In this retrospective cohort study, a total of 42 patients (25 women and 17 men), with an average follow-up of 3.5 years, with clinical signs of zygapophysial joint involvement who had failed conservative treatment (pre-procedure symptom duration mean 6.03 years; range 5 months to 48 years) and had a favorable response to a diagnostic medial branch block or zygapophysial joint injection, were identified. The identified subjects underwent radiofrequency denervation at the Hospital for Special Surgery Physiatry Department from 1998 to 2006. Patient's records were reviewed, and a questionnaire was provided, completed on phone call follow-up, or mailed by the patient. The success of this intervention in providing improvement in pain and function was analyzed using the Numerical Rating Scale (NRS)-11, North American Spine Society (NASS) four-point satisfaction index, and a modified Roland-Morris Disability Questionnaire (RMDQ). Fifty-two percent of patients reported a successful outcome with improved function at a minimum follow-up period of 2 years (mean 3.5 years, range 2-8.8 years). Patients in the failure group were more likely to be older and have moderate to severe neuroforaminal stenosis (77.8%) compared to patients in the success group (24.2%). Radiofrequency denervation in selected patients with chronic zygapophysial joint-mediated low back pain provides long-term reduction in pain and improved function with minimum morbidity.

Clinical outcomes of ultrasound-guided aspiration and lavage in calcific tendinosis of the shoulder.

OBJECTIVE: To determine the effectiveness of ultrasound-guided aspiration and lavage in the treatment of patients with calcific tendinosis of the shoulder. MATERIALS AND METHODS: Retrospective chart review resulted in 44 patients who were identified as having received ultrasound-guided aspiration of calcific tendinosis of the shoulder between 2000 and 2003. Of these, 36 patients were interviewed by telephone for pre- and posttreatment assessment of pain, shoulder function, prior shoulder surgery, injury, and prescribed treatment modalities with a follow-up time of 8 months to 3.1 years (mean = 22.5 months). L'Insalata score, numeric rating scale (NRS), and patient satisfaction score served as outcome measures. RESULTS: Our criteria for a successful outcome included (1) 12-point or greater improvement in the L'Insalata shoulder rating questionnaire, (2) 2-point or greater improvement in the NRS, (3) patient satisfaction rating of "good", "very good", or "excellent", (4) patients' willingness to undergo the procedure again if they experienced recurrent symptoms, and (5) 1 month or less of analgesic medication use after the aspiration procedure. We determined that ultrasound-guided aspiration of calcific tendinosis of the shoulder resulted in a successful outcome for 75% (27/36) of patients with a mean 20.2-point improvement in the L'Insalata shoulder rating questionnaire score and a mean 6.4-point improvement in the NRS (p < 0.01). CONCLUSION: This retrospective study suggests that ultrasound-guided aspiration and lavage of calcific shoulder deposits appears to be an efficacious therapeutic modality for treatment of calcific tendinosis. Further studies involving prospective randomized controlled trials would be helpful to further assess the long-term efficacy of this procedure as a minimally invasive treatment for calcific tendinosis of the shoulder.

Fluoroscopically guided caudal epidural steroid injections for lumbar spinal stenosis: a restrospective evaluation of long term efficacy.

BACKGROUND: Degenerative lumbar spinal stenosis is a frequent cause of disability in the elderly population. Epidural steroid injections are a commonly used conservative modality in the treatment of patients with degenerative lumbar spinal stenosis. Relatively few studies have specifically addressed the efficacy of epidural steroid injections for spinal stenosis, with success rates varying from 20% to 100%. OBJECTIVE: To assess the efficacy of fluoroscopically guided caudal epidural steroid injections in the management of degenerative lumbar spinal stenosis. DESIGN: Retrospective chart review and follow-up study. METHODS: All the patients who had undergone at least one fluoroscopically guided caudal epidural steroid injection between 1995 and 2002 were reviewed. All of the caudal epidural steroid injections were done with fluoroscopic guidance. MAIN OUTCOME MEASURES: Visual Numeric Scale (VNS), Roland-Morris Disability Questionnaire (RMDQ), North American Spine Society Patient Satisfaction Index (NASS), and subsequent surgery. RESULTS: Ninety-five patients selected from chart review met inclusion criteria. Eighty (84%) completed the follow-up questionnaire by mail or telephone interview. Patients received an average of 1.6 epidural steroid injections. Twelve patients subsequently underwent surgical procedures. A VNS improvement of 50% or greater was seen in 35% of patients. A functional improvement of 2 points or greater was seen on the RMDQ in 36% of patients. Long-term success of treatment was seen in 35% of patients. The concurrent presence of degenerative spondylolisthesis was the only variable which was found to have a significant positive correlation with successful outcomes (P < 0.009). CONCLUSION: Caudally placed fluoroscopically guided epidural steroid injections offered a safe, minimally invasive option for managing pain caused by lumbar spinal stenosis. The concurrent presence of degenerative spondylolisthesis appears to be an independent positive prognostic factor for successful outcome.

Lumbar intraspinal synovial cysts: conservative management and review of the world's literature.

BACKGROUND CONTEXT: Lumbar intraspinal synovial cysts are an important cause of axial and radicular spine pain. Controversy about nonsurgical versus surgical treatment persists. PURPOSE: To evaluate the efficacy of nonsurgical management of symptomatic lumbar intraspinal synovial cysts (LISCs). STUDY DESIGN/SETTING: Retrospective review set in outpatient physiatry office. PATIENT SAMPLE: Ten patients (8 women, 2 men; average age, 60 years) with LISCs and average symptom duration of 7.9 months. OUTCOME MEASURES: Numerical pain rating scale (NRS-11), Roland-Morris disability outcome measure, patient satisfaction, and surgery. METHODS: Patients with LISCs were identified and their charts were reviewed. Those patients whose symptoms correlated with the level of LISC-induced extradural compression were eligible. All patients received conservative care and a fluoroscopic-guided lumbar spine injection. The primary author conducted telephone follow-up. RESULTS: All 10 patients had unilateral radicular pain. Seven had stable neurologic deficits. Magnetic resonance imaging and computed tomography/myelography, respectively, identified a LISC in 8 and 2 patients. Five patients had cyst aspiration followed by steroid instillation; 5 patients had cyst aspiration followed by a transforaminal epidural steroid injection. Average length of follow-up was 50.4 weeks. Only 1 patient had sustained benefit. One patient had no benefit and refused surgery. Eight patients underwent surgery and had a good result. CONCLUSION: In our opinion, nonsurgical management in patients with LISC-induced radicular pain does not appear to be as successful as surgery.

Fluoroscopically guided aspiration of a symptomatic lumbar zygapophyseal joint cyst: a case report.

Lumbar zygapophyseal joint cysts are potential pain generators in patients with axial pain and/or lower-limb radicular pain. The traditional treatment of symptomatic cysts that do not respond to conservative measures is surgical decompression. Percutaneous needle aspiration under fluoroscopic guidance is a potential minimally invasive treatment option. We present a patient with a large symptomatic L4-5 zygapophyseal joint cyst and right L5 radiculopathy who responded well to percutaneous aspiration.