Primary Cleft Lip and Palate Repair in Assam, India: Does Preoperative Anthropometric Analysis Help Identify Patients With Increased Surgical Risk in a Clinically Prescreened Population?

OBJECTIVE: To compare anthropometric z-scores with incidence of post-operative complications for patients undergoing primary cleft lip or palate repair. DESIGN: This was a retrospective observational analysis of patients from a surgical center in Assam, India, and includes a cohort from a single surgical mission completed before the opening of the center. SETTING: Patients included in the study underwent surgery during an Operation Smile mission before the opening of Operation Smile's Guwahati Comprehensive Cleft Care Center in Guwahati, India. The remaining cohort received treatment at the center. All patients received preoperative assessment and screening; surgery; and postoperative care, education, and follow-up. PATIENTS, PARTICIPANTS: Our sample size included 1941 patients and consisted of all patients with complete information in the database who returned for follow-up after receiving primary cleft lip repair or primary cleft palate repair between January 2011 and April 2013. INTERVENTIONS: Preoperative anthropometric measurements. MAIN OUTCOME MEASURE(S): Postoperative complications. RESULTS: Anthropometric z-scores were not a significant predictor of adverse surgical outcomes in the group analyzed. Palate surgery had increased risk of complication versus lip repair, with an overall odds ratio of 5.66 (P < .001) for all patients aged 3 to 228 months. CONCLUSIONS: Anthropometric z-scores were not correlated with increased risk of surgical complications, possibly because patients were well screened for malnutrition before surgery at this center. Primary palate repair is associated with an approximate fivefold increased risk of developing postoperative complication(s) compared with primary lip repair.

Atraumatic Medullary Osteonecrosis of the Tibia and Femur Treated With Intraosseous Orthobiologics.

Osteonecrosis (ON) is a painful condition involving bony cell death with resultant architectural collapse. This report discusses the case of a 50-year-old Caucasian female who presented to an outpatient musculoskeletal clinic with severe chronic left knee pain. She had a history of ulcerative colitis and resultant chronic corticosteroid exposure with subsequent development of knee ON. She was treated with an intraosseous autologous bone marrow concentrate (BMC), demineralized bone matrix (DBM), and platelet-rich plasma (PRP) injection. At 11 months post-injection, she demonstrated a significant improvement in pain scores, mobility, activity, and decreased narcotic use. Intraosseous orthobiologic injection for the treatment of knee ON is a promising procedure with a reasonable safety profile that warrants further study as an alternative to surgical intervention.

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.

Use of Bone Marrow Concentrate to Treat Pain and Musculoskeletal Disorders: An Academic Delphi Investigation.

BACKGROUND: Acute and degenerative musculoskeletal disorders are among the most common etiologies of disability worldwide. Recently, there has been interest in the field of regenerative medicine to bridge the gap between conservative and surgical management of these conditions. Autologous bone marrow concentrate is one type of injectate that has increased in popularity over the last few decades. Though there is promising evidence supporting its efficacy, standard of care practice guidelines to govern the appropriate use and implementation of such technology are currently lacking. OBJECTIVES: The aim of this article is to report findings from a survey administered using the Delphi technique to a group of physicians using bone marrow concentrate in practice to determine best practice consensus regarding optimization of patient safety and education. STUDY DESIGN: Delphi panel technique. SETTING: The study was first announced at a national meeting and continued remotely across the United States via 4 rounds of online surveys. METHODS: An initial panel of 30 expert members was convened and a 5-member steering committee was established. Four rounds of consensus questionnaires totaling 11 unique questions were distributed. Ten questions included a 5-point Likert scale from "Strongly Agree" to "Strongly Disagree," and one question had a selection of 5 options regarding minimum level of evidence required. The anonymized aggregate results of each round were shared with the group prior to voting in the subsequent round in accordance with the Delphi process. Consensus was defined as 80% agreement of the statements indicating either "Strongly Agree" or "Agree" for the 10 questions with the Likert Scale and 80% agreement among 2 of 5 choices in the question regarding levels of evidence. RESULTS: Three invited participants were excluded by the second round of questions due to lack of response in a timely manner, leaving 27 physicians queried. Nine of the 11 questions met criteria for > 80% consensus. Areas of agreement included importance of a treatment registry, candidacy grading, expanded informed consent, scientific accuracy in advertising, institutional review board approval for novel uses, performance of procedures by only licensed physicians or mid-level providers with direct physician oversight, use of image guidance for injections, data submission for publication in peer reviewed literature, and a minimum requirement of case-series level of evidence for use of bone marrow concentrate in musculoskeletal medicine. The 2 areas that did not meet criteria for consensus included online publishing of individual clinic data and standards around cell counting for dosing. LIMITATIONS: The Delphi panel of experts was convened on a voluntary basis rather than a nomination process. Our panel of experts were all physicians who use bone marrow concentrate in practice, therefore it is possible that a different panel of experts within other disciplines would reach different conclusions. CONCLUSIONS: There is significant consensus among a panel of physicians performing bone marrow concentrate injections regarding best practice guidelines for musculoskeletal conditions.

Platelet-rich plasma for the treatment of coccydynia: a case report and review of regenerative medicine for coccydynia.

Aim: To describe the successful treatment of coccydynia using ultrasound-guided injection of platelet-rich plasma. Setting: Outpatient orthopedic practice. Patient: 17-year-old female with BMI of 42.6. Case description: The patient presented with 6 months of nontraumatic coccygeal pain exacerbated by sitting. Physical exam was significant for point-tenderness over the sacral hiatus and coccyx. A corticosteroid injection around the sacrococcygeal ligament was administered with immediate resolution of her pain following the injection with the anesthetic. The patient reported significant pain relief for 1 week. The superficial sacrococcygeal ligament was then treated with a platelet-rich plasma injection under US guidance. Results: The patient reported a 70% improvement in pain and sitting tolerance at 6 weeks. By 6 months post injection, her pain was 100% resolved, and she remained pain free at the 12-month follow-up. Conclusion: Platelet-rich plasma may be considered as a treatment option in patients with refractory coccydynia.

Surgical margin reporting in breast conserving surgery: Does compliance with guidelines affect re-excision and mastectomy rates?

PURPOSE: Margin status is important in guiding decisions to re-excise following breast-conserving surgery (BCS) for breast cancer. The College of American Pathologists (CAP) developed guidelines to standardize pathology reporting; however, compliance with margin documentation guidelines has been shown to vary. The aim of this retrospective study was to determine whether compliance with CAP guidelines affects re-excision and mastectomy rates. METHODS: We identified 1423 patients diagnosed with breast cancer between 1998 and 2006 who underwent BCS with negative margins. CAP compliance was categorized as maximal, minimal, or non-compliant. Statistical analyses were performed comparing the frequency of re-excision and mastectomy after initial BCS according to CAP margin reporting guideline compliance. Data were adjusted for provider facility by including a clustering variable within the regression model. RESULTS: Patients with non-compliant margin reporting were 1.7 times more likely to undergo re-excision and/or mastectomy than those with maximally compliant reporting. Level of compliance was most strongly associated with the frequency of mastectomy; non-compliant margin reporting was associated with a 2.5-fold increase in mastectomy rates compared to maximally compliant reporting. The results did not substantially change when the analyses accounted for clustering at the provider facility level. CONCLUSIONS: Our findings suggest that compliance with CAP guidelines in pathology reporting may be associated with variation in re-excision and mastectomy rates following BCS.