Proximal Interphalangeal Joint Silicone Arthroplasty for Osteoarthritis: Midterm Outcomes.

Background: Osteoarthritis of the proximal interphalangeal (PIP) joint affects a large percentage of the population and can lead to significant functional disability. The purpose of this study is to evaluate the midterm clinical effectiveness of PIP joint arthroplasty for nonrheumatic arthritis. Methods: A single-center retrospective cohort study evaluating preoperative and postoperative objective and subjective measures was conducted. Range of motion (ROM), Disabilities of the Arm, Shoulder and Hand scores, key pinch strength, grip strength, and satisfaction with respect to pain, deformity, function, and strength were measured. Results: Forty-five fingers in 25 patients were followed up for a mean period of 42 months. Preoperative and postoperative mean ROM was equivalent at 59.1° and 59.2°, respectively. Postoperative grip and key pinch strength showed significant improvement and near normalization compared with contralateral extremity. Complication rate was 37% with 20% requiring revision surgery. Patients with diabetes mellitus had higher odds of requiring revision surgery. Pain scores improved from 7.4 to 1.9 on a visual analog scale. Overall satisfaction was high at 84%, and 91% of patients would have the surgery performed again. Conclusions: Silicone arthroplasty for osteoarthritis of the PIP remains a good option for pain relief. Our study presents midterm follow-up data that support significant pain relief, increased grip and key pinch strength, and high satisfaction associated with this implant.

Preoperative evaluation of the body contouring patient: the cornerstone of patient safety.

The obesity pandemic has resulted in increasing cases of bariatric surgery and subsequent issues related to excess skin and laxity for patients. This patient population requires unique insight and consideration as part of the preoperative evaluation. Nutritional derangements are common, psychosocial issues are prevalent, and the sequelae of past and present medical conditions can all affect surgical planning and outcomes. This article familiarizes the plastic surgeon with the issues of the body contouring candidate and provides tools that may assist in surgical planning.

Demystifying the U.S. Food and Drug Administration: understanding regulatory pathways.

BACKGROUND: The field of plastic surgery has been at the forefront of ideation and innovation. Surgeon scientists today continue to develop novel products that fulfill the needs of the medical community and patients. Part of this process requires the approval from various regulatory agencies and offices, including the U.S. Food and Drug Administration. Unfortunately, medical training does not include regulatory knowledge, and many surgeon scientists find the regulatory pathway and U.S. Food and Drug Administration perplexing, overly complicated, and insurmountable. The authors aim to clearly outline the path of the regulatory process as it pertains to the U.S. Food and Drug Administration and its various jurisdictions that may relate to the plastic surgeon. METHODS: The authors aim to demystify the classification system, 510(k), and Premarket Approval processes for devices; clarify the Investigational New Drug and New Drug Application requirements for drugs; and explain how human cells, tissues, and cellular or tissue-based products are classified and approvals obtained. RESULTS: The structure of the U.S. Food and Drug Administration, its offices, and their roles are delineated, and the complex process of obtaining approval to market devices, drugs, biologics, and combination products is explained in a manner that is broadly useful to innovators whether new or experienced. CONCLUSION: The authors provide information for innovators and inventors developing promising technologies to be more knowledgeable and motivated to embrace the process in a fashion that will potentially save time and errors in U.S. Food and Drug Administration submissions.

Nutritional assessment of bariatric surgery patients presenting for plastic surgery: a prospective analysis.

BACKGROUND: Assessment of nutritional status in the growing postbariatric patient population remains controversial. Previous literature suggests that these patients have poor nutrition that may have adverse effects on surgical outcomes. The authors sought to determine the optimal method of nutritional assessment in postbariatric patients. METHODS: One hundred patients presenting for body contouring after bariatric surgery were consecutively enrolled in an institutional review board-approved prospective study. A trained nutritionist assessed protein and calorie intake. All patients underwent baseline laboratory assessment. RESULTS: Eighteen percent of subjects had less than the recommended daily protein intake. Hypoalbuminemia was observed in 13.8 percent of subjects, with hypoprealbuminemia in 6.5 percent. Nearly forty percent of all patients had evidence of iron deficiency, with vitamin B12 deficiency present in 14.5 percent. Ten percent of subjects (all women) were confirmed to have iron deficiency anemia. Impaired fasting glucose was seen in 6.2 percent of subjects, whereas 3.6 percent had hemoglobin A1c levels greater than 6.5. Increasing age (odds ratio, 1.07) and greater change in body mass index (odds ratio, 1.11) were predictors of low protein intake. Dumping syndrome led to 13.3 times increased odds of low albumin levels. CONCLUSIONS: The results suggest that inadequate nutrition is common among postbariatric patients presenting for body contouring. The lack of correlation between methods of nutritional assessment supports the combination of multiple methods in determining overall nutritional status. The presence of dumping syndrome, a large change in body mass index, and advanced age may help to identify patients with an increased risk of nutritional deficiency.

A double-blind controlled trial of polyglytone 6211 versus poliglecaprone 25 for use in body contouring.

The use of absorbable sutures to obtain secure dermal closure in surgeries such as body contouring is common. The risk of complications based on the absorption rate of these materials is unknown. This study attempts to determine whether a faster absorbing suture material such as polyglytone 6211 will lead to fewer complications such as extrusion and granuloma formation as compared with less rapidly absorbing materials such as poliglecaprone 25. Concomitantly, this study also attempts to explore the possible negative outcomes that may be due to faster loss of strength, such as dehiscence and poor scar aesthetics. We found that extrusion occurs less frequently with the rapidly absorbed polyglytone 6211 suture material, without increase in granuloma formation, infection, dehiscence, cellulitis, necrosis, seroma formation, and hematoma formation. We also observed no clinical difference in the cosmetic appearance of scars at the 12-week postoperative follow-up visit.

Current status of grafts and implants in rhinoplasty: Part II. Homologous grafts and allogenic implants.

LEARNING OBJECTIVES: After reading this article, the participant should be able to: 1. Understand the challenges in restoring volume and structural integrity in rhinoplasty. 2. Identify the appropriate uses of various homologous grafts and allogenic implants in reconstruction, including: (a) freeze-dried acellular allogenic cadaveric dermis grafts, (b) irradiated cartilage grafts, (c) hydroxyapatite mineral matrix, (d) silicone implants, (e) high-density polyethylene implants, (f) polytetrafluoroethylene implants, and (g) injectable filler materials. 3. Identify the advantages and disadvantages of each of these biomaterials. 4. Understand the specific techniques that may aid in the use these grafts or implants. SUMMARY: This review specifically addresses the use of homologous grafts and allogenic implants in rhinoplasty. It is important to stress that autologous materials remain the preferred graft material for use in rhinoplasty, owing to their high biocompatibility and low risk of infection and extrusion. However, concerns of donor-site morbidity, graft availability, and graft resorption have motivated the development and use of homologous and allogenic implants.

Current status of grafts and implants in rhinoplasty: part I. Autologous grafts.

LEARNING OBJECTIVES: After reading this article, the participant should be able to: 1. Understand the challenges in restoring volume and structural integrity in rhinoplasty. 2. Identify the appropriate uses of various autografts in aesthetic and reconstructive rhinoplasty (septal cartilage, auricular cartilage, costal cartilage, calvarial and nasal bone, and olecranon process of the ulna). 3. Identify the advantages and disadvantages of each of these autografts. SUMMARY: This review specifically addresses the use of autologous grafts in rhinoplasty. Autologous materials remain the preferred graft material for use in rhinoplasty because of their high biocompatibility and low risk of infection and extrusion. However, these advantages should be counterbalanced with the concerns of donor-site morbidity, graft availability, and graft resorption.

Body mass and surgical complications in the postbariatric reconstructive patient: analysis of 511 cases.

OBJECTIVE: To analyze the impact of body mass indices on postbariatric reconstructive surgery complications. BACKGROUND: An increasing number of patients are presenting after massive weight loss due to bariatric surgery or diet and exercise. Many of these patients have residual obesity, which may compromise outcomes. METHODS: 449 patients were enrolled in a prospective registry over 6 years. Measures included medical complications and comorbidities. All cases were analyzed together as well as in two subgroups: single procedure cases (Group I) and multiple procedure cases (Group II). RESULTS: 449 patients (407 female, 42 male) with a mean age of 44.5 +/- 10.3 underwent 511 separate operations. Mean pre-weight loss BMI (Max BMI) was 51.6 +/- 9.5 kg/m2, post-weigh loss BMI (Current BMI) was 29.3 +/- 5.0 and the DeltaBMI was 22.3 +/- 7.5. For all cases (n = 511), the presence of a surgical complication was directly related to Max BMI (P = 0.002) and DeltaBMI (P = 0.002) but not Current BMI.Group I consisted of 194 single procedure cases. Complications in Group I were related to Max BMI (P = 0.006) and Current BMI (P = 0.02) but not DeltaBMI. Max BMI impacted infections (P = 0.003) while Current BMI impacted dehiscence (P = 0.009) and infections (P = 0.03). Group II consisted of 317 cases with only DeltaBMI directly related to overall complications (P = 0.01). CONCLUSIONS: Body mass indices influence complications in postbariatric reconstructive surgery. Current BMI may impact complications in single-procedure cases, but appears to play less of a role in larger cases. Careful patient selection, assessment of surgical complexity, and recognition of the particular risks increased by residual obesity can help to optimize outcomes in this patient population.