Socket Reconstruction Research Articles

The current alternative for ocular surface and anophthalmic socket reconstruction, cryopreserved umbilical amniotic membrane (cUAM).

This report presents the results of using cryopreserved umbilical amniotic membrane (cUAM) as an alternative mucosal graft for ocular surface reconstruction in cases of anophthalmic socket contracture (ASC), cicatricial entropion (CE), and conjunctival-scleral defects. The study included patients who underwent non-commercial implantation of cUAM grafts (prepared by corneal banking methods) for ASC, CE, conjunctival defect, and scleral melting. The main success criteria for this study were the comfortable fitting of the ocular prosthesis in ASC patients, the natural eyelid position in CE patients, and the degree of conjunctivalisation in melting patients. cUAM transplantation was performed in 2 patients who could not use a prosthetic eye due to conjunctival contracture, 2 patients with CE, and 1 patient with conjunctival defect and 1 patient with conjunctival-scleral melting. The primary outcome was achieved in 83.3% (5/6) of patients. In one patient with CE, partial healing was achieved due to the persistence of CE in the medial upper eyelid. cUAM is a viable alternative to mucosal grafting for reconstructing the bulbar and palpebral conjunctival surface, fornix, and orbit, with reduced donor morbidity and shorter surgical time. Its regenerative ability allows for tissue defect healing and improves cosmetic appearance through epithelialization within weeks.

Autologous Platelet-rich Fibrin as a Three-dimensional Structural Scaffold in the Healing of Contracted Orbital Sockets.

Evaluation of platelet-rich fibrin as an adjuvant in surface healing of contracted orbital sockets. Prospective, interventional, and comparative study of 25 patients with moderate to severe contracted sockets conducted over 2 years (February 2020-February 2022). Group 1 underwent a dermis-fat graft with fornix forming sutures supplemented by a platelet-rich fibrin membrane, while group 2 received a dermis-fat graft with fornix forming sutures only. Patients over 18 years were evaluated as per prefixed inclusion and exclusion criteria. Assessments were conducted at 1, 3, and 12 months postsurgery, focusing on wound evaluation, socket epithelialization, postoperative pain, prosthesis rehabilitation, and complications, if any. Wound evaluation and pain intensity were assessed utilizing the wound evaluation score and visual analog scale, respectively. Socket epithelization was documented clinically at every visit. The study showed a mean age of 38.8 ± 8.8 years, with a 2:1 male-to-female ratio. Group 1 consistently scored higher on wound evaluation score than group 2 at all follow-up points. In group 1, 81.8% achieved a maximum wound evaluation score at 4 weeks and 100% at 3 and 12 months, compared to group 2's 42.8%, 50%, and 57.1%, respectively (p < 0.05). Postoperative contracture occurred in 3 group 2 patients at the final follow-up, with 6 showing unsatisfactory appearance. Group 1 demonstrated significantly lower pain intensity on postoperative day 1 (p = 0.03), and greater epithelization at 4 weeks. platelet-rich fibrin appears to be an effective solution for enhancing wound healing during socket reconstruction, attributed to its sustained release of growth factors and mesenchymal stem cells.

Factors affecting anophthalmic socket reconstruction outcomes using autologous oral mucosal graft

BackgroundLimited studies have reported surgical outcomes that are defined by strict criteria following grade 2 or 3 socket reconstruction using an oral mucosal graft (OMG). We aimed to determine factors influencing surgical outcomes of anophthalmic socket reconstruction using OMG in patients with grade 2 or 3 socket contractures.MethodsThirty-seven patients who underwent socket reconstruction with autologous OMG between January 2007 and December 2017 were retrospectively analyzed. The successful outcome was defined as an eye prosthesis wearing without experiencing displacement and the absence of any re-operations or additional surgeries following socket reconstruction. Factors affecting surgical outcomes were identified using multivariate analysis.ResultsA total of 15 male and 22 female patients (mean age: 40.2 ± 17.2 years) were included. The median duration of socket contracture was 21.5 years. Grade 2 and 3 socket contractures, based on Tawfik’s classification, were reported in 20 and 17 patients, respectively. Twenty-eight and eight patients underwent socket reconstruction using OMG alone and OMG combined with a hard palate graft, respectively. The success rates of grades 2 and 3 socket contracture reconstruction were 80.0% and 52.9%, respectively. Multivariate analysis demonstrated that only grade 3 contractures were predictive of worse outcomes. At the final visit (mean follow-up: 6.3 years), 34 patients (91.9%) could wear their eye prostheses.ConclusionsSocket reconstruction using autologous OMG can provide acceptable results in grade 2 and 3 contractures; however, satisfactory results were more significantly reported in grade 2 than in grade 3 contractures.

Giant Cyst as a Dermis Fat Graft Complication in Socket Anophthalmia Post Enucleation

Introduction : Enucleation is often performed in children diagnosed with advanced unilateral group E retinoblastoma as a primary treatment to save life. After performing enucleation, a Dermis Fat Graft (DFG) is often placed inside the socket to give volumes into the orbital cavity. A dermis fat graft hopefully will grow along with the children, promoting orbital bone development. Rare complications following dermis fat graft implant is cyst formation. The purpose is to present a case of giant orbital cyst formation in socket anophthalmia.&#x0D; Case Illustration : A 6 year old boy came with proptotic left socket anophthalmia with history of enucleation with DFG for retinoblastoma. On examination, we found a proptotic socket 1.5 years after enucleation. CT Scan examination revealed cyst formation on left socket anophthalmia. We did a cyst excision using cryo and implanted 16 mm acrylic implant for the socket reconstruction.&#x0D; Discussion : Cyst is minor complications following DFG implantation in socket anophthalmia. It’s estimated occurred in 1.5-3.8% patients. Some of the causes are gaps in between the dermis and recipient bed, epithelial island residue on DFG, or delayed conjunctivalization of the dermis. Cyst excision with careful dissection is the main management for this cases, preferably using cryo probe in order to remove the cyst in toto.&#x0D; Conclusion : Management for the giant cyst removal following DFG implant is a challenging task due to the recurrence possibility. Complete cyst excision and replacement of orbital implant is mandatory in order to re-establish the cosmetic appearance of the patient.

Research on the work of ameliorative pumping stations of the Volga branch of FSBI "Man-agement "Saratovmeliovodkhoz" and ways to improve them

The relevance of the study is to obtain objective and reliable data on the actual operation of the reclamation pumping stations of the Volga branch of FSBI "Management "Saratovmeliovodkhoz". In order to improve the efficiency of the irrigation system, it is necessary to evaluate the work of each structural element of it, to make sure of the efficiency or malfunction of units and to develop a set of measures to solve existing problems if they exist. The object of research is pumping equipment of irrigation systems. Special equipment in the form of devices and sensors reflecting the pressure in the system was used during the study. The study was conducted from May 1, 2022 to August 30, 2022. The data were recorded on a daily basis. Monitoring was conducted on 4 pump units 1D1250-63. According to the results of the monitoring the final data were systematized by plotting graphs, diagrams and correlation analysis. The reasons of failures and breakdowns of the system during active operation were determined. A possible solution could be improvement and reconstruction of the suction socket.

Reconstruction of the Exenterated Orbit with an Island Pericranial Flap: A New Surgical Approach

Background:Reconstruction of the bony socket after orbital exenteration is a matter of much debate. Prompt defect closure with a microvascular flap is desirable but involves a major surgical procedure and hence, places considerable burden on the patient. The new surgical technique presented here permits a technically simpler wound closure with fewer complications after orbital exenteration.Methods:Between May 2014 and June 2022 in the ENT department of Regensburg University, nine patients underwent exenteration and reconstruction with a pericranial flap. The flap was raised via a broken line incision in the forehead or endoscopically, incised in a roughly croissant-like shape, then introduced into the orbit through a tunnel in the eyebrow. A retrospective analysis of the patients and considerations about determining the size, shape, and vascular supply of the flap are presented.Results:Flap healing was uncomplicated in all cases. Only 6 weeks after surgery, the flap was stable, making it possible to start adjuvant therapy and prosthetic rehabilitation swiftly. The flap is adapted to the near cone-shape of the orbit. The mean (± standard deviation) surface area of the measured orbits is (39.58 ± 3.32) cm2. The territory of the angular artery provides the periosteal flap arterial blood supply. Venous drainage is via venous networks surrounding the artery.Conclusions:Use of the pericranial flap makes it possible to close the orbital cavity promptly with minimal donor site defect and a short operating time, thereby minimizing the surgical risk and speeding up physical and psychological recovery.

Anophthalmic socket syndrome: Management and cosmetic outcome

To describe the management strategy and evaluate the outcome of Anophthalmic socket syndrome. This retrospective case study includes 40 patients with anophthalmic socket syndrome who attended the orbit and ocular oncology department of Ispahani Islamia Eye Hospital from January 1, 2018, to June 31, 2021 were included in this study. All the information regarding age, gender, initial pathology, type of initial surgery, implant, degree of contraction, the procedure of socket reconstruction, the management outcome and complication were recorded and analyzed correctly. 17 males (42.5%) and 23 females (57.5%) with a mean age of 24.47 years were included in the study. Trauma (30%) and Tumour (25%) were the main reasons for initial eye removal. Enucleation performed in 24 (60%) cases was the most common initial surgery. The primary implant was not done in 20 (50%) cases. Mild socket contraction (grade 1) was recorded in 10 (25%) cases. Moderate contraction (grade 2 and 3) in 25(62.5%) cases and severe contraction (grade 4) in 5(12.5%) cases were recorded. Only fornix forming suture was done in 10 (25%) cases, mucous membrane graft (MMG) was done in 27 (67.5%) cases and dermis fat graft was done in 3 (7.5%) cases. All the patients were followed up routinely for six months. The outcome was good in 16 (40%) cases, acceptable in 20 (50%), and poor in 4 (10%) cases. A common complication was infection (5%) and fat atrophy (5%).: Anophthalmic socket syndrome remains a challenging entity for the oculoplastic surgeon. Multiple factors help to determine the overall prognosis of socket reconstruction. The goal of management is to provide a socket that can maintain a cosmetically acceptable prosthesis. Timely detection, proper correction of the underlying pathology and a high level of care directly correlate with expected surgical outcomes.

An Alternative Technique for Ridge Reconstruction of Extraction Socket with Buccal Dehiscence: A Clinical Case Report

A clinical case report describing the use of an alternative ridge reconstruction technique to augment an extraction socket with buccal dehiscence. Unassisted healing following flapless extraction of teeth possessing such buccal wall defects leads to severe bone and soft tissue deformities, and an aesthetic compromise. Current treatment strategies are based on the assumption that maintenance of the buccal tissues leads to superior clinical outcomes. Our proposed ridge reconstruction technique challenges this concept by suggesting that a lack of buccal bone in fact, enhances bone augmentation with our proposed treatment strategy, as demonstrated by the positive radiographic changes. Our technique consists of socket grafting with deproteinised bovine bone particulates and socket sealing with an immediate ovate pontic. The ability to achieve effective circumferential socket seal is paramount in maximising ridge augmentation. The increase in bone volume thus provides the ideal surgical environment for implant placement in the prosthetically driven position, ensuring optimal aesthetics and function of the implant. The patients also benefit from the provision of an immediate tooth replacement and the reduced postoperative morbidity as this is a flapless technique, involving no sutures or barrier membranes. The ultimate result is the ability to achieve superior clinical outcomes with maximum benefit for the patients

The Cortical Shield for Facial Bone Reconstruction of Severely Damaged Sockets with Simultaneous Implant Placement: A Feasibility Clinical Trial.

To evaluate a novel proof-of-principle technique of simultaneous bone regeneration and implant placement in severely damaged sockets. This study consisted of patients who required a single implant and presented with severe facial bone loss. Individuals were randomly assigned to either the immediate or delayed implant placement protocol. Socket reconstruction and simultaneous implant placement were performed through periosteal-guided bone regeneration. Implants were encased in a customized shield of autogenous cortical bone harvested from an adjacent site. Re-entry surgery was performed at 12 to 18 weeks. Peri-implant tissues and pink esthetics were assessed following established success criteria. Of the 34 patients treated, 28 patients-consisting of 15 women and 13 men with an average age of 50.8 ± 4.5 years-continued to the final follow-up. All individuals showed new facial cortical bone regeneration at second-stage implant surgery after an average healing time of 14.9 ± 2.2 weeks (range: 12 to 18 weeks). Implants remained stable after loading. Success rates were 100% at 12 months. Mean pink esthetic score (PES) was 7.8 ± 1.2 (range: 6 to 9 on a scale of 0 to 10). Linear regression analysis showed that provisionalization and attachment loss are independent risk factors affecting pink esthetics (P < .01). Mild and moderate/severe attachment loss decrease pink esthetic scores by 0.9 and 1.7 points, respectively (95% CI: 0.2-1.5; P < .01). The use of provisional restorations improves pink esthetic scores by 1.6 points (95% CI: 0.8-2.4; P < .001). A PES > 7 was four and five times more likely to be expected for delay and immediate implants, respectively, if the implant had a provisional restoration delivered post-second-stage (RR = 4 to 5; 95% CI: 1-31; P = .07; P = .02). Cramér's V test showed a strong association between lack of implant provisionals and low pink esthetic scores (≤ 7, value = 0.7; P = .02). Facial implant transparency at follow-up was absent, and all implants had a band of keratinized tissue > 2 mm. Facial bone regeneration and simultaneous implant placement is feasible in severely damaged sockets through periosteal-guided bone regeneration after a short healing period following immediate or delayed protocols. The assisted regenerated intrasocket bone allows for functional implant stability. Adjacent tooth attachment loss and lack of implant provisionalization negatively impacts pink esthetics. The proposed approach decreases costs, morbidity, and treatment duration and eliminates the need for multi-stage approaches.

Conjunctival Relaxing Incisions with a Bare Bed: An Overlooked Privilege in Contracted Sockets.

The aim of reconstruction of a contracted socket is to retain a satisfactory prosthesis. Simple procedures to modify the socket architecture as first line options could avoid multiple staged procedures, increased surgical time, harvesting tissues or use of allografts. The objective of this study was to evaluate the outcome of modifying the socket architecture by making conjunctival relaxing incisions leaving it bare to re-epithelialize and compare it to dermis-fat graft. A retrospective review of all socket reconstruction surgeries in our hospital over a period of 10 years (July 2009 to June 2019) was done. The two procedures which were compared were dermis-fat graft (DFG) and conjunctival relaxing incisions (CRI) without a graft. In the latter, the split conjunctiva was left bare under a conformer and temporary tarsorrhaphy. The conjunctiva was allowed to re-epithelialize under cover of topical antibiotic and steroid. The patients included had a mean age of 24 years (n=8) in the DFG group and 36 years (n=10) in the CRI group. The most common cause of anophthalmic socket was enucleation for tumour and evisceration for trauma in the two groups, respectively. Six patients (75%) in the DFG group and six (60%) in the CRI group achieved good prosthesis retention (P = 0.51). None had post-operative infection. Transverse conjunctival relaxing incisions with tissue stretching can be a safe first line option to rehabilitate a contracted socket.

A Sandwich-Like Oral Mucosa Graft-Conjunctiva In Situ-Dermis-Fat Graft for Reconstruction of the Anophthalmic Socket with Ocular Infection History.

IntroductionA novel technique of using a sandwich-like structure, namely, an oral mucosa graft (OMG)–conjunctiva in situ–dermis-fat graft (DFG) (OMG-C-DFG), to reconstruct a contracted and low-capacity anophthalmic socket for a patient with ocular infection history was evaluated.MethodsThis was retrospective case study of four patients (cases) who underwent anophthalmic socket reconstruction surgery in which the OMG-C-DFG technique was applied. The procedures were performed in the Department of Ophthalmology at the Ninth People’s Hospital, Shanghai JiaoTong University School of Medicine (Shanghai, China). Postoperative cosmetic appearance, graft outcome, the ability to wear an ocular prosthesis, and postoperative complications were evaluated.ResultsThe median (± standard deviation) age of patients was 41.5 ± 22.1 (range 10–60) years. All patients suffered from contracted and low-capacity anophthalmic sockets. Three patients had a history of orbital implant infection and one patient had a history of enucleation due to exogenous endophthalmitis after globe rupture. The DFG and OMG were harvested from the abdominal region and lower lip, respectively. All four patients achieved a good postoperative appearance, with dermal surfaces appearing pink and smooth, the orbital areas showing good fullness, the ocular prosthesis showing good wearability, and no narrowing of the sockets. There was no lipid secretion, fat lysate outflow, or infection in the graft bed. There were only small amounts of scars and no infection of the donor site.ConclusionThe sandwich-like structure can be effectively used to reconstruct the contracted and low-capacity anophthalmic socket with a history of orbital infection in one stage.

All-Inside Anterior Cruciate Ligament Reconstruction: A Review of Advance and Trends.

Anterior cruciate ligament (ACL) injury is a common disease in orthopedics and mostly occurs as a noncontact injury in athletes. Patients' knee joint stability, which is crucial to their athletic ability, cannot be restored through conservative treatment; it can only be restored through ACLR (ACL reconstruction) surgery. The surgical techniques of ACLR are constantly evolving, from bone tendon bone (BTB) grafting combined with interface screw fixation to hamstring tendon autograft or allogeneic tendon and of suspension device constructs. In particular, the currently prevalent all-inside technique featuring good cosmetic results and quick recovery of early functions not only ensures the stable fixation of grafts but also reduces surgical trauma. This review compares the advantages and disadvantages of different aspects of all-inside ACLR, including graft selection and preparation, bone socket reconstruction, fixation methods, and surgical technique effects and limitations. It has been found that the all-inside technique excels both anatomically and clinically but still requires further development. Besides, it has some limitations, and high-quality randomized controlled trials are still required to compare the long-term effects of the all-inside technique and other ACLR techniques.

Modified procedure of anterior orbital exenteration enables eye socket reconstruction: A retrospective cohort study.

The conventional procedure of anterior orbital exenteration is unfavorable for eye socket reconstruction, whereas a modified procedure enables socket reconstruction and prosthesis fitting. Our study aims to compare the cosmetic outcomes between these 2 surgical techniques.We retrospectively recruited patients treated with modified or conventional exenteration during January 2015 to May 2021 in our hospital. The conventional approach was performed along with dermis-fat graft transplantation. The modified approach was conducted followed by eye socket reconstruction and eyelid blepharoplasty. The clinical data were collected and analyzed, including demographics, tumor characteristics, postoperative complications, tumor-related events, and cosmetic outcomes.Forty-nine patients were consecutively recruited in this study, including 22 cases of modified exenteration and 27 cases of conventional exenteration. Forty-four subjects (89.8%) were diagnosed with ocular surface malignancies (conjunctival melanoma and squamous cell carcinoma) and 5 subjects (10.2%) were diagnosed with extraocular stage of uveal melanoma. After follow-up for 31.8 ± 17.1 months, the 1-, 2-, 5-year overall survival rate was calculated as 100%, 79.2%, and 59.2% in the Modified group, and 94.2%, 73.8%, and 51.5% in the Conventional group. Comparison of the survival curves showed no significant differences. In the Modified group, all patients received orbital implant placement and eye socket reconstruction. The implant motility was satisfactory in 12 cases (54.5%) with movements in 3 to 4 directions. The eyelid function was acceptable in 17 cases (77.3%) with no entropion, ectropion or lower lid laxity. Ocular prosthesis was delivered in 17 cases (77.3%) with successful fitting in 11 cases (64.7%). The self-rated cosmetic score was statistically (t test, P < .0001) higher in the Modified group (6.7 ± 0.9) than the Conventional group (2.2 ± 0.4).The modified approach to anterior orbital exenteration enables eye socket reconstruction and cosmetic rehabilitation while still preserves the curable chance for the treatment of advanced periocular/intraocular malignancies.

The consequences of dermis fat graft in the reconstruction of anophthalmic socket with large orbital implant exposure

The consequences of dermis fat graft in the reconstruction of anophthalmic socket with large orbital implant exposure

Facial cosmetic enhancement by secondary implant and ocular prosthesis to avoid camouflaging hair style

Aim: Aim of this study is to access the improvement in psychosocial awareness and self-image of surgical anophthalmic patient after cosmetic rehabilitation with secondary implant followed by ocular prosthesis. Materials and Methods: It was conducted with 15 surgical anophthalmic patients who maintained a special and unnatural hair style to hide the facial deformity from others. These hair styles included growing long hair on a particular side of the head, covering part of the forehead and eyes. This makes other people curious and it does not look normal. Result: After reconstruction of the a anophthalmic socket by secondary ball implant along with scleral graft and followed by fitting of a well matching custom designed ocular prosthesis, the psychological condition, self-confidence of the patients were improved significantly. The follow up photographs of the same patient revealed that they no longer maintained the earlier special type of hair style. They looked confident in normal hair pattern. Conclusion: The study suggest that the psychological well being of those living with facial deformity due to eye loss is related to having a pessimistic outlook and the beliefs a patients has about their appearance and how accepted they feel by the society. Keywords: Contracted socket, Orbital implant, Socket reconstruction, Scleral graft.

Efficacy and safety of an artificial dermal graft for the reconstruction of exenterated sockets: a preliminary report.

The purpose of this study is to report our experience with the use of artificial dermis grafts for orbital socket reconstruction following orbital exenteration (OE). A retrospective study was conducted in our ocular oncology centre from May 2018 to June 2020 in patients undergoing OE for orbital malignancies in whom an artificial dermis device (Integra® template, 2 layers) was used for reconstruction. Data recorded included demographics, previous and adjuvant treatments, aetiologies, surgical procedure, surgical reconstruction, complications and follow-up. The main outcome measure was the time between OE and the full granulation of the cavity. Ten patients (mean age, 71.3 years [43-92]) were included. Tumours originated from the conjunctiva (n = 5, 50%), eyelid (n = 3, 30%) and orbit (n = 2, 20%). Nine patients underwent total OE, and one required enlarged OE. Orbital reconstruction was performed using an artificial dermis alone (n = 9, 90%) or combined with regional flaps (n = 1, 10%). The mean granulation time was 3.3 weeks (2-4). Three (30%) patients received adjuvant radiotherapy 1 month post-surgery. The mean time to spontaneous epithelialization was 9.4 weeks (6-12). Preoperative and postoperative radiotherapy was not associated with a delayed epithelialization of the socket (p = 0.463 and p = 0.236, respectively). One (10%) and 2 (20%) patients experienced postoperative socket infection and an ethmoidal fistula, respectively. The mean follow-up was 11.6 months (6-16). Using artificial dermis grafts alone or with regional flaps appears to be a viable surgical procedure for orbital socket reconstruction. They reduce surgical morbidity and hospital stay. Preoperative and postoperative radiotherapy does not seem to delay socket healing.

An objective technique to calculate dermis-fat graft volume.

We describe an objective method to measure the volume of a dermis-fat graft (DFG) implant for socket reconstruction. We reviewed the charts of 10 patients undergoing dermis fat grafting as a primary or secondary implant for anophthalmic socket reconstruction between January 2018 and December 2019. The amount of the DFG required to replace the volume of an appropriate spherical implant for the operated eye was predetermined. The volume of the DFG implant was measured by the water displacement method as per the Archimedes principle. Patient demographics, complications, and the outcome were analyzed regarding cosmesis and volume replacement. All patients were satisfied with the final cosmesis. Follow-up ranged from 6 to 18 months (mean 10.7 months). Thus, we concluded that the water displacement method is a simple and easy procedure to objectively determine the amount of the autologous DFG needed to replace the volume in an anophthalmic socket.

A Dynamic Costal Cartilage Platform Promotes Ocular Prosthetic Excursion: Preliminary Report.

Background:The quality of life of the face involves mainly its configuration, and it plays an important functional role in communication skills. Thus, having artificial eyes is extremely essential in maintaining the quality of life of patients who have lost their eyeballs. We will present the details of the technique, including tips and innovations for eye socket reconstruction using spherical costal cartilage implant, which leads to dynamic and aesthetic results.Methods:There were 19 cases of eye socket reconstruction using costal cartilages from 2008 to 2020. The patient age range was 18–77 years old. There were 10 cases of anophthalmia and 9 cases of ocular phthisis. In our operative method, we created the costal cartilage implant by harvesting the sixth costal cartilage of the affected side. If extraocular muscle remained, we sutured each muscle to the cartilage.Results:Our method made application of thin artificial eyes possible in all cases. Regarding postoperative complications, there were 1 case of postoperative infection and 1 case of vascular failure of temporoparietal fascial flap. Seventeen cases were wet socket, and 2 cases were dry socket. We had attained movement of the artificial eye in 15 cases.Conclusions:Eye socket reconstruction is considered one of the most challenging operations, and various postoperative complications appear in the long term. Costal cartilages are considered as the most suitable materials to create the base of artificial eyes.

Efficacy and Safety of Human Fibrinogen Concentrate for the Treatment of Patients with Congenital Fibrinogen Deficiency: Combined Results of the FORMA-02 and FORMA-04 Clinical Trials

Introduction: Congenital fibrinogen deficiency (CFD) is a rare disorder which results from a complete lack (afibrinogenemia) or low levels (hypofibrinogenemia) of functional fibrinogen. Treatment with human fibrinogen concentrate (HFC) can treat bleeding episodes and prevent blood loss in surgical treatment in patients with CFD. Herein we report combined data from two clinical studies on the efficacy and safety of HFC for the treatment of bleeding episodes (BEs) and surgical prophylaxis in adult, adolescent and pediatric patients. Methods: Both FORMA-02 and FORMA-04 were multinational, multicenter, prospective, open-label, uncontrolled Phase 3 studies for the use of HFC in adult and pediatric patients with CFD. They reported the hemostatic efficacy and safety of human fibrinogen concentrate (HFC: Fibryga® Octapharma) for on-demand treatment of BEs and surgical prophylaxis using objective criteria. Efficacy was assessed by the trial investigators and adjudicated by an independent data monitoring and end-point adjudication committee (IDMEAC). All adverse events (AEs) and serious AEs were recorded. Results: The two studies included a total of 39 patients who received HFC. The median (range) age across both studies was 17 (1-54) years, with 14 pediatric (aged 0-11), 6 adolescent (aged 12-18) and 19 adult patients (aged &amp;gt;18). Treatment of Bleeding Events 32 patients received HFC for the treatment of 99 bleeding events (BEs), 97 minor and 4 major. Of these, 72 were spontaneous, and 27 were due to trauma. 10 BEs occurred in pediatric patients (8 minor, 2 major), and 89 in adult/adolescents (87 minor, 2 major). The mean (±SD) total dose per BE was 65.51 mg/kg (±26.47) for adult/adolescent patients (ages 12-54) and 93.78 (±64.60) for pediatric patients (ages 0-11). Investigator-assessed and IDMEAC rated hemostatic efficacy are shown in Table 1. Overall hemostatic efficacy was rated as success (rating of excellent or good) for 99.0% of BEs by the IDMEAC. Treatment efficacy results were comparable when analyzed by age subgroup of adult (≥18 years), adolescent (&amp;gt;12-&amp;lt;18 years) and in two groups of pediatric patients (&amp;lt;6 years and 6-12 years). Surgical prophylaxis A total of 12 patients received HFC across 15 surgeries (13 minor and 2 major), 3 in pediatric patients (major: splenectomy; minor: circumcision and pulpectomy), and 12 in adults/adolescents (major: eye enucleation with socket reconstruction; minor: knee radioisotope synovectomy [n=2], dental extraction [n=3], circumcision [n=2], excision of circumcision scar bud, root canal operation, skin biopsy, and debridement of superficial necrosis). Mean (±SD) loading dose administered prior to surgery was 77.39 (±20.22) in adult/adolescent patients and 78.50 mg/kg (±27.96) for pediatric patients. Seven surgeries required multiple infusions, with the two major surgeries requiring 5 and 7 maintenance infusions, and the five minor surgeries requiring median (range) 3 (1-4) maintenance infusions. Intra- and post-operative hemostatic efficacy for all surgeries is shown in Table 1. Overall hemostatic efficacy of all the procedures was rated 100% successful by both the investigator and IDMEAC assessment. Safety A total of 101 AEs occurred in 23 patients (59.0%), including 16 serious AEs in 6 patients. Of these, 5 AEs in 4 patients were considered to be possibly related to treatment. These included a mild skin reaction (itchiness and redness), ischemia due to digital microthrombi, peripheral phlebitis of the upper limbs, and a portal vein thrombosis following splenectomy. No allergic/hypersensitivity reactions or deaths were observed during either of the studies. Conclusions: HFC treatment was shown to be efficacious for on-demand treatment of BEs and perioperative prophylaxis in this rare CFD population, across two Phase 3 clinical trials. Efficacy was comparable for adult, adolescent and pediatric patients. A favorable safety profile was seen for the treatment of patients with congenital afibrinogenemia with HFC. Disclosures Djambas Khayat: Octapharma: Research Funding. Kruzhkova:Octapharma: Current Employment. Solomon:Octapharma: Current Employment. Schwartz:Octapharma: Current Employment. Peyvandi:Octapharma: Research Funding. OffLabel Disclosure: On label use: Fibryga for treatment of bleeding episodes Off label use: Use of Fibryga as surgical prophylaxis in the US

Reconstruction of the Extraction Socket

Extensive reviews have concluded that grafting of the socket reduces bone loss regardless of product or method. However, nothing has been shown to reliably and completely maintain alveolar dimensions. We advocate a biologically driven and anatomically based approach for reconstruction of the socket. There are various socket manipulations that we have found to predictably prepare a site for dental implant. The combination of graft construct design and socket management maximizes graft success for any practitioner. Each socket should be treated individually, and products or methods used that are coincident with the complexity of the defect in question.