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PubMed2006

Inferior stability of a biodegradable cement plug. 122 total hip replacements randomized to degradable or non-degradable cement restrictor.

INTRODUCTION: Modern cementing technique demands high intramedullar cement pressure to create an optimum fixed cement support of the femoral stem. Pressure resistant, stable closure of the canal therefore is absolutely necessary. Biodegradable cement restrictors, if corresponding to above mentioned attributes, could be of immense advantage in case of potential revision surgery. MATERIAL AND METHODS: A prospective, randomized trial was performed on a consecutive series of 130 patients who underwent primary cemented total hip arthroplasty due to hip arthrosis to compare a degradable cement restrictor and a non-degradable cement restrictor in their ability to resist distal migration during stem insertion. RESULTS: The median cement plug length measured 27 mm (range -12 to 126 mm, 95% confidence interval (CI) 20-33 mm) in the biodegradable restrictor group and 15 mm (range 0-61 mm, 95% CI 12-18 mm) in the non-degradable restrictor group (P=0.003). A significant effect of the relationship between the difference of restrictor size and the diameter of the femoral canal on length of cement distal of the tip of the stem in between the two groups was evident (P=0.031). CONCLUSION: The results indicate insufficient intramedullary plug fixation of the degradable restrictor probably due to the elastic material properties which also may lead to inferior precision in restrictor size choice.

Absorbable Implants↗
PubMed2006

Void filling of tibia compression fracture zones using a novel resorbable nanocrystalline hydroxyapatite paste in combination with a hydroxyapatite ceramic core: first clinical results.

INTRODUCTION: It is a generally accepted standard surgical practice to fill-in the metaphyseal defect zones resulting from the reduction of tibia compression fractures. The development of various innovative bone substitutes is also currently on the increase. MATERIALS AND METHODS: In our prospective study, we used Ostim, a novel resorbable nanocrystalline hydroxyapatite paste, together with Cerabone, a solid hydroxyapatite ceramic, in combination with angularly stable osteosynthesis to treat 24 tibia compression fractures. Types B2 and B3, as well as types C2 and C3 fractures, according to the AO classification, were included in the study. RESULTS: The mean total range of joint motion in terms of flexion and extension was improved from the immediate postoperative value of 79 +/- 14 degrees to 97 +/- 13 degrees at 6 weeks after surgery, to 109 +/- 16 degrees at 3 months, and finally to 118 +/- 17 degrees at 1 year. In three patients, a delayed wound healing was observed as a local complication. CONCLUSION: The use of the Ostim and Cerabone combination is an effective method in treating tibia compression fractures with large defect zones left after reduction.

Absorbable Implants↗
PubMed2006

Polylactide (LTS) causes less inflammation response than polydioxanone (PDS): a meniscus repair model in sheep.

BACKGROUND: Incidence of meniscus injury has increased in today's active society. Arthroscopical refixation yields better results than partial meniscectomy. The best healing rates are achieved by sutures. As non-degradable sutures are permanent foreign bodies, slow absorbable materials are needed. A slow degradable suture with high concentration of polylactide acid, the so-called "long-term suture" (LTS, Panacryl), has been suggested to produce a higher inflammatory response than conventional polymer sutures [Vicryl, Dexon or polydioxanone (PDS)]. The aim of the study was to assess LTS for meniscus repair after a traumatic lesion and to evaluate immunological response, biodegradation and healing. METHODS: In 24 randomised sheep, a radial tear of the medial meniscus was sutured by either PDS or LTS. Twelve sham-operated animals served as control. Half of the sheep were killed after 6 months, the other half after 12 months. The medial and lateral meniscus, synovial membrane, articular cartilage and ascendant lymph nodes up to the kidney were examined. Joint effusion was evaluated by MRI. RESULTS: The synovial membrane was significantly thinner in the LTS group (6 months 85 +/- 10 microm, 1 year 100 +/- 28 microm) than in the PDS group (6 months 165 +/- 10 microm, 1 year 175 +/- 23 microm, P < 0.001) and the controls (6 months 150 +/- 17 microm, 12 months 192 +/- 21 microm, P < 0.001). The joint effusion was higher in the PDS than in the LTS group after 6 months, and tended to be higher in controls. In controls, effusion tended to be higher than in the LTS group. In all medial departments, osteoarthritis evolved much more intensely than in the lateral knee departments (P < 0.01). Bilateral lymph nodes from the groin up to the kidneys were larger (crosscut area) after 6 months in the controls (2.28 +/- 0.7 mm(2)) and PDS treated animals (2.3 +/- 0.7 mm(2)) than in the LTS group (1.3 +/- 0.3 mm(2), P < 0.001). After 1 year, node size differed significantly between controls and animals from the LTS group (1.98 +/- 0.4 mm(2) vs. 1.5 +/- 0.2 mm(2), P < 0.05), and between animals from the PDS and the LTS group (2.5 +/- 0.1 mm(2) vs. 1.5 +/- 0.2 mm(2), P < 0.001). CONCLUSION: The polylactide thread LTS causes less immunological reaction and synovitis than a polydioxanone suture (PDS). CLINICAL RELEVANCE: LTS may serve as an alternative to PDS for repair of slow healing structures such as tendons and menisci.

Absorbable Implants↗
PubMed2003

Clinical aspects and strategy for biomaterial engineering of an auricle based on three-dimensional stereolithography.

At the present time, the partial and/or complete reconstruction of an auricle from autologous rib cartilage is one of most widely published techniques. In the field of tissue engineering, different techniques have been described to generate cartilage tissue using isolated chondrocytes. The basis of these tissue-engineering techniques is bioresorbable or non-bioresorbable biomaterials, which serve as a three-dimensional cell carrier. Tissue engineering of an auricle requires preformed bioresorbable biomaterials designed to fit the form of a patient's auricular defect. Three-dimensional imaging acquired from computed tomography scans or laser surface scanning has become an important tool in modern medicine. This study represents the preoperative procedures for the reconstruction of an auricle through tissue engineering in accordance with the clinical aspects. Hyaff 11, a hyaluronic acid derivative, was used as a three-dimensional cell carrier for isolated human nasoseptal chondrocytes. The chondrocytes were amplified in a conventional monolayer culture before the cells were seeded on a hyaluronic non-woven mesh and cultured in vitro for 4 weeks. The chondrogenic potential of human nasal chondrocytes in Hyaff 11 was investigated by confocal laser scanning microscopy, histology (toluidine blue) and immunohistochemistry (collagen type II). Computer-aided design (CAD) and manufacture of an auricle model with stereolithographical methods were used for the prefabrication of a bioresorbable three-dimensional cell carrier designed in the form of a patient's auricular defect. The cell carrier used was Hyaff 11, a fully benzyl-esterified hyaluronic acid derivative. Confocal laser scanning microscopy has shown good cell attachment, a homogenous distribution of amplified chondrocytes and a viability of more than 90%. After 4 weeks in vitro culture the human nasoseptal chondrocytes synthesized new cartilage with the expression of cartilage-specific collagen type II. In order to shape a patient's designed scaffold the auricle model was fitted exactly and symetrically to the contralateral side. Subsequently, the mirror image patient-specific model was used to prepare an identical scaffold model made of a fully benzyl-esterified hyaluronic acid derivative. The bioresorbable scaffold that was produced gave a satisfactory representation of auricle structure. Bioresorbable preformed biomaterials in the form of a patient's auricle defect represent an important prerequisite for the tissue engineering of autologous auricle grafts. Hyaff 11 seems to be a promising material for tissue engineering of cartilage transplants, and the application of this approach will improve conventional reconstructive surgery in the future.

Absorbable Implants↗
PubMed2006

Biocompatibility testing of novel multifunctional polymeric biomaterials for tissue engineering applications in head and neck surgery: an overview.

Biomaterial research and tissue engineering are rapidly growing scientific fields that need an interdisciplinary approach where clinicians should be included from the onset. Biocompatibility testing in vitro and in vivo comprise the agarose-overlay test, the MTT test, direct cell seeding tests and the chorioallantoic membrane test for angiogenic effects, among others. Molecular biology techniques such as real-time polymerase chain reaction and microarray technology facilitate the investigation of tissue integration into biomaterials on a cellular and molecular level. The physicochemical characterization of biomaterials is conducted using such methods as X-ray photoelectron spectroscopy (XPS) and scanning electron microscopy (SEM). Excellent biocompatibility and biofunctionality were demonstrated for a series of recently developed multifunctional biodegradable, polymeric biomaterials both in vitro and in vivo. Novel, multifunctional polymeric biomaterials offer a highly specific adjustment to the physiological, anatomical and surgical requirements and can thereby facilitate new therapeutic options in head and neck surgery.

Absorbable Implants↗
PubMed2000

A model for xenogenic immune response.

PURPOSE: To develop a model for analyzing the immune response after xenogenic human fetal retinal pigment epithelium (HFRPE) transplantation. MATERIALS AND METHODS: Pure sheets of HFRPE cells were isolated and attached to poly (DL-lactide-co-glycolide) polymer films and HFRPE spheroids were formed. The spheroids were transplanted into the subretinal space of New Zealand albino rabbits and were observed for 5 months. Bare polymer films were transplanted into the subretinal space of Dutch Belted pigmented rabbits, serving as control. RESULTS: The polymer film was biodegraded within 3 weeks in the subretinal space. No signs of inflammation in the retina or choroid were observed. The HFRPE spheroids were easily transplanted into the subretinal space. The immune response was followed with ophthalmoscopy. Light microscopy indicated a localized immune response in the transplanted area in which the retina and the choroid were infiltrated with immune cells. This infiltration was denser in the choroid. CONCLUSIONS: HFRPE spheroid transplantation may be utilized as a model for studying the xenogenic immune response after HFRPE transplantation. This model may also have applications in evaluating the role of immune suppressive agents in preventing rejection after HFRPE transplantation.

Absorbable Implants↗
PubMed2004

Safe closure technique for distal pancreatic resection.

BACKGROUND AND AIMS: Various methods had previously been employed to manage the proximal pancreas after distal resection (mattress sutures with duct ligation; pancreato-enterostomy or stapling with stainless steel staples, etc.), with postoperative complications in 13% (6%-30%) of the cases, on average. In our practice, to reduce these complications, we applied staples made from Polysorb (Auto Suture), an absorbable lactomer. PATIENTS/METHODS: In the past 10 years, distal pancreatic resection in 90 patients [62 men, 28 women, mean age 52 (24-72)] years) was followed by closure of the resection surfaces with absorbable lactomer clips. Indications for distal resection (with or without splenectomy) were: focal pancreatic necrosis, spontaneous pancreatic fistulas, abscess, pseudocyst, traumatic disruption, segmental chronic obstructive pancreatitis in the tail, and benign (cystadenoma, or insulinoma) or malignant tumours. RESULTS: The postoperative period was uneventful in all these patients, without any complications (pancreatic fistula, abscess or bleeding). No morbidity or mortality occurred in the follow-up period (6 or 12 months postoperatively) with the exception of one patient who suffered a pseudocyst 6 months after surgery and was treated by cysto-jejunostomy. CONCLUSIONS: The clinical results clearly demonstrated that the application of absorbable lactomer staples for closure of the transected margin of the pancreas is a safe alternative to the standard closure technique. These staples can be applied in all cases when distal pancreatic resection is indicated for benign or malignant disorders or a traumatically injured pancreatic gland.

Absorbable Implants↗
PubMed2004

Custom-shaping system for bone regeneration by seeding marrow stromal cells onto a web-like biodegradable hybrid sheet.

New bone for the repair or the restoration of the function of traumatized, damaged, or lost bone is a major clinical need, and bone tissue engineering has been heralded as an alternative strategy for regenerating bone. A novel web-like structured biodegradable hybrid sheet has been developed for bone tissue engineering by preparing knitted poly(DL-lactic-co-glycolic acid) sheets (PLGA sheets) with collagen microsponges in their openings. The PLGA skeleton facilitates the formation of the hybrid sheets into desired shapes, and the collagen microsponges in the pores of the PLGA sheet promote cell adhesion and uniform cell distribution throughout the sheet. A large number of osteoblasts established from marrow stroma adhere to the scaffolds and generate the desired-shaped bone in combination with these novel sheets. These results indicate that the web-like structured novel sheet shows promise for use as a tool for custom-shaped bone regeneration in basic research on osteogenesis and for the development of therapeutic applications.

Absorbable Implants↗
PubMed2003

Comparison of the performance of the Gea extracorporeal knot with the Roeder extracorporeal knot and the classical knot.

BACKGROUND: Laparoscopy is useful to treat surgical diseases, yet tying sutures in the cavity is a challenge. A knot to secure tissue approximation, which would be hand-made, secure, simple, easy, quick, reliable, and extracorporeal without extra mechanical devices, was developed and named the Gea knot. METHODS: A comparative study of the Gea knot, the Roeder knot, and the classical surgical knot, as the gold standard, using polypropylene, silk, catgut, polyglycolic acid, and Polyglactin 910, all of them of 1-0 caliber, was performed in pigs. Measurements were time to perform, slippage, and breaking point which was measured with a manual digital tensiometer. RESULTS: The Gea knot was significantly faster statistically to perform than the Roeder knot and more resistant against rupture and slippage. The slippage rate was significantly lower statistically in the Gea knot than in the Roeder knot when Polyglactin 910 and polypropylene were used. CONCLUSION: The Gea knot is a good alternative for laparoscopic procedures.

Absorbable Implants↗
PubMed2006

The "stamp method": a new treatment for perforated peptic ulcer?

BACKGROUND: The aim of this study was to develop a simple method for closure of a perforated peptic ulcer, making it more accessible for laparoscopic surgery. METHODS: An experimental pilot study was performed using five male Wistar rats. The perforation was closed by a bioabsorbable patch made of lactide-glycolid-caprolactone fixed with glue onto the outside of the stomach. RESULTS: Postoperatively, there were no signs of leakage or other complications. Histologically, there were no signs of inflammation on the inside of the stomach, and there was a 50% reduction of the perforation each successive postoperative week. No adverse reactions because of the degradable material or glue were observed. CONCLUSIONS: Treatment of a perforated peptic ulcer by placing a patch of biodegradable material like a "stamp" on the outside of the stomach is a feasible option.

Absorbable Implants↗
PubMed2006

An audit of cystic duct closure in laparoscopic cholecystectomies.

BACKGROUND: Cystic duct leak is an infrequent but potentially serious complication of laparoscopic cholecystectomy. The aims of this audit were to assess the efficacy of locking absorbable clips for closing the cystic duct and to compare the results with those for simple clips used previously. METHODS: The records for all laparoscopic cholecystectomies performed in one hospital over a 5-year period were reviewed. The results were compared using Fisher's exact test. RESULTS: Of 518 laparoscopic cholecystectomies attempted, 24 were excluded. There was no difference in age or sex ratio between the two groups. Cystic duct leaks were identified either on endoscopic retrograde choloangio pancreatography or at laparotomy. No cystic duct leak occurred in any of the 344 locking clip cases, as compared with 3 leaks in the 146 (2%) simple clip cases (p < 0.03). CONCLUSION: Locking clips are a safe and effective method for cystic duct closure. They are associated with a reduced cystic duct leak rate, as compared with that for simple clips.

Absorbable Implants↗
PubMed1998

Simplified hepatic resection utilizing absorbable polyglycolic acid-based tape and other ligature apparatus.

Hepatic resection has been increasing in frequency in the management of metastatic or primary neoplasms of the liver. Although mortality for this procedure has steadily decreased, the associated morbidity remains high. Morbidity is mainly associated with operative time and blood loss, especially in jaundiced and cirrhotic patients. During hepatic resection, control of bleeding from various sources is the most important problem faced by surgeons. During conventional lobectomy, despite prior control of hepatic artery and portal vein to that lobe, bleeding still occurs from the opposite lobe or back flow from hepatic veins. We usually apply Pringle's maneuver for hemostasis, but consequently there is postoperative hepatic dysfunction. We have previously investigated methods for vascular occlusion at the site of liver resection. We developed a new absorbable polyglycolic acid-based tape (breadth, 3 mm; length, 70 cm) for use in hepatic mass ligation, as well as two types of ligature apparatus. Hemostasis was achieved with these devices, and all lobar, segmental, and non-anatomic resections were performed without prior control of the portal venous system, hepatic arterial inflow, and hepatic venous outflow before parenchymal resection. This significantly shortened the operative time, as well as decreasing the blood loss during hepatic resection, with consequent reduction of postoperative morbidity. The use of this absorbable tape may reduce the incidence of local infection, abscess formation, and septicemia.

Absorbable Implants↗
PubMed2002

The use of poly-L-lactic acid in lumbar interbody cages: design and biomechanical evaluation in vitro.

Cage design and cage material may play a crucial role in the incidence of postoperative complications reported with current non-absorbable interbody cage devices. Bioabsorbable poly-L-lactic acid cage devices may have potential benefits. The purpose of this study was to determine the required strength of poly-L-lactic acid cages for use in experimental goat studies and to evaluate the mechanical properties of different cage designs in situ. The yield and ultimate strength of native goat motion segments (L1-L6) were determined; the yield strength was used as a design parameter for the cages. The mechanical behaviour of two types of poly-L-lactic acid cages, the influence of endplate perforation, differences between toothed and smooth cages, and the influence of cage filling were biomechanically tested and compared to native motion segments. Only axial compression until failure of the motion segments was performed. Dual energy X-ray absorptiometry was used to determine bone mineral content. The yield and ultimate strength of the native motion segments were 3.5 and 7.0 kN, respectively. Based on these data, flexible and stiff poly-L-lactic acid cages were designed with strengths of 3.5 and 7 kN, respectively. Poly-L-lactic acid cages, whether with or without bone graft and perforating the endplates, did not reduce the compressive strength of motion segments as compared to native segments. However, toothed titanium cages, with the same geometry, negatively influenced the segments' compressive strength, which effect was reduced using smooth titanium cages.

Absorbable Implants↗
PubMed2006

Evaluation of the 96/4 PLDLLA polymer resorbable lumbar interbody cage in a long term animal model.

Arthrodesis using interbody cages has demonstrated high fusion rates. However, permanent cages are exposed to stress-shielding, corrosion, and may require explanation when necessary. Polylactic acid (PLA) bioresorbable cages are developed for avoiding these problems, but significant tissue reaction has been reported with 70/30 PLDLLA in some preclinical animal studies. The objective was to evaluate 96/4 PLDLLA cages in a sheep model over 3 years. Sixteen sheeps underwent one level anterior lumbar interbody fusion using 96/4 PLDLLA cages, filled and surrounded with cancellous bone graft from the iliac crest. Six groups of three animals were killed after 3, 6, 9, 12, 24, and 36 months. Harvested lumbar spine had radiographic, MRI, and CT evaluation and histological analysis. Histological results: cage swelling and slight signs of fragmentation associated to fibrocartilaginous tissue apposition at 3 months; bone remodeling around the cage with direct apposition of the mineralization front at 6 months; active cage degradation and complete fusion around the cage at 9 months; cage fragmentation and partial replacement by bone tissue at 12 months; bone bridges in and around the cage at 24 months; full resorption and intervertebral fusion at 36 months. Radiological results: partial arthrodesis at 3 months; definite peripheral arthrodesis at 6 months; similar aspect at 9 months; significant cage resorption at 12 months; definite inner and outer fusion at 24 months; complete cage resorption and calcification at the location of the cage at 36 months confirmed histological observations. Radiographic, CT scan, MRI, and histological data were consistent for showing progressive resorption of 96/4 PLDLLA, interbody fusion, and bone remodeling, with no significant signs of local intolerance reaction. These results are promising and suggest further development of 96/4 PLDLLA cages.

Absorbable Implants↗
PubMed2004

Use of bioresorbable membrane to prevent postoperative small bowel obstruction in transabdominal aortic aneurysm surgery.

PURPOSE: To evaluate the efficacy of Seprafilm (Genzyme, Cambridge, MA, USA), a bioresorbable membrane, in preventing or reducing early postoperative small bowel obstructions after transabdominal abdominal aortic aneurysm (AAA) surgery. METHODS: Fifty-one patients underwent aortic reconstruction via a midline transperitoneal approach for infrarenal AAAs. Twenty-one patients underwent surgery with Seprafilm (Seprafilm group) and the remaining 30 patients did not (control group). The incidence of early small bowel obstruction was examined, and the time before liquid and solid diet were resumed was also compared to assess postoperative paralytic ileus. RESULTS: Patients in the Seprafilm group resumed a liquid diet on postoperative day (POD) 2.4 +/- 1.1 and a solid diet on POD 4.0 +/- 1.3, whereas the patients in the control group resumed a liquid diet on POD 3.3 +/- 1.9 and a solid diet on POD 5.4 +/- 3.4. These values were not significantly different between the two groups; however, the incidence of early postoperative small bowel obstruction was significantly lower ( P < 0.05) in the Seprafilm group (0/21) than in the control group (6/30). CONCLUSION: These findings suggest that Seprafilm may help to prevent early postoperative small bowel obstructions after transabdominal AAA surgery.

Absorbable Implants↗
PubMed2005

Bioresorbable hyaluronate-carboxymethylcellulose membrane (Seprafilm) in surgery for rectal carcinoma: a prospective randomized clinical trial.

PURPOSE: To evaluate the effectiveness of Seprafilm in preventing abdominal adhesions after radical resection of rectal carcinoma, and to observe whether Seprafilm had any adverse effects in patients treated with radiotherapy and chemotherapy. METHODS: A total of 62 patients participated in this prospective randomized clinical study, which was conducted to compare the outcomes of patients operated on with Seprafilm (SEPRA+) with those operated on without Seprafilm (SEPRA-). All patients received preoperative radiotherapy, followed by a two-stage operation, and 5-fluorouracil (5-FU)-based systemic chemotherapy. The primary endpoint of severity and extent of adhesions were evaluated at the time of ileostomy closure. The secondary endpoint included the recurrence of tumors, late complications, and outcome. RESULTS: Seprafilm significantly reduced the adhesions in both the midline incision area and peristomal area. This in turn reduced the operation time, blood loss, and extent of the incision at ileostomy closure. Seprafilm was not associated with any postoperative complications or chemoradiation-related toxicity, nor did it affect recurrence or survival rates. CONCLUSION: Seprafilm effectively reduced abdominal adhesions in chemoradiated patients, and had no adverse effects on the oncologic results of fully introduced adjuvant therapy. Thus, Seprafilm is a safe and effective tool for use in rectal carcinoma surgery.

Absorbable Implants↗
PubMed2002

A new bioabsorbable sleeve for staple-line reinforcement: report of a clinical experience.

PURPOSE: The most frequent and troublesome complication after resection of an emphysematous lung is persistent air leakage. This report describes our recent experience of using sleeves made of polyglycolic acid to reinforce staple-lines to reduce air leaks after resection of emphysematous lung. METHODS: We used bioabsorbable sleeves made of polyglycolic acid (PGA) for staple-line reinforcement during lung resections in 25 patients with emphysema. RESULTS: Immediately after stapling, no air leaks were detected in 20 patients (80%), although prolonged air leaks lasting for more than 7 days were observed in three patients (12.5%). CONCLUSION: PGA sleeves do not constitute a foreign body that stays in the host lung, and they require no rinsing at the time of clinical use. Therefore, the PGA sleeve could be a promising new material instead of non-absorbable materials and xenomaterials for staple-line reinforcement.

Absorbable Implants↗