Safety Profile of Synthetic Elastic Degradable Matrix for Soft Tissue Reconstruction in Foot & Ankle Surgery

2021 ◽  
pp. 193864002110676
Author(s):  
Michael J. Kelly ◽  
Daniel M. Dean ◽  
Syed H. Hussaini ◽  
Steven K. Neufeld ◽  
Daniel J. Cuttica

Background Augmentation of soft tissue repairs has been helpful in protecting surgically repaired tissues as they heal. FlexBand (Artelon, Marietta, Georgia) is a synthetic, degradable, polycaprolactone-based polyurethane urea (PUUR) matrix that has been investigated and used for soft tissue repair in a variety of settings. The purpose of this study was to evaluate the safety profile of a PUUR matrix in a large cohort of patients undergoing soft tissue repairs about the foot and ankle. Methods A retrospective chart review of consecutive patients who underwent surgery using FlexBand to augment a soft tissue repair was performed to evaluate for major and minor complications related to the PUUR matrix. Results. A total of 105 patients with an average >6 months follow-up were included. The most common procedures were spring ligament repair, Achilles tendon repair, and Brostrom. There were 12 complications. Four major complications occurred with only 1 requiring PUUR matrix removal. Patients with wound complications had a higher body mass index (BMI) and rate of smoking. Conclusion Complication rates involving PUUR matrix in soft tissue foot and ankle reconstruction procedures are low and comparable with historical complication rates. The PUUR matrix is safe for use in a variety of soft tissue procedures about the foot and ankle. Level of Evidence: Level 4, Retrospective case-series

2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0016
Author(s):  
Jie Chen ◽  
Akhil Sharma ◽  
Craig C. Akoh ◽  
Rishin J. Kadakia ◽  
Selene G. Parekh

Category: Sports Introduction/Purpose: Bioabsorbable suture anchors have been popularized due to potential for osseous integration, less interference with diagnostic imaging, and ease of use. Recently, ultrasound assisted suture anchor systems have been introduced with the benefits of obtaining interdigitation with cancellous bone while maintaining a minimal footprint. In a cadaveric study, ultrasound assisted suture anchors demonstrated a similar pullout strength and less system displacement when compared to a benchmark bioabsorbable anchor system. However, the failure and complication rates of ultrasound assisted bioabsorbable anchors has never been demonstrated in a clinical setting. We studied the Stryker SonicAnchor by examining complication rates in foot and ankle procedures and secondarily determined the efficacy by evaluating clinical outcomes of surgeries using this anchor system. Methods: A retrospective analysis was performed on all patients treated by the primary investigator using the Stryker SutureAnchor between the dates of May 2016 and February 2018. We included all patients for which the anchor was used during surgery with at least 2 year followup including VAS and FAOS scores. We recorded baseline demographic information as well as the type of surgery patients underwent. We recorded all intraoperative and postoperative complications for these surgeries. In addition, we compared preoperative and postoperative clinical scores. Results: 57 patients met inclusion criteria. On average, patients were 53 years old at the time of surgery. Mean followup was 32.8 months. Mean BMI was 30.36. Three patients reported current tobacco use (5.3%), four patients (7.0%) had type II diabetes mellitus at the time of their surgery, and only one patient (1.8%) had osteoporosis. Common procedures were Achilles repair including Haglund’s resection, peroneal surgery, and lateral ligament reconstruction. There were two deep infections requiring reoperation, one medial malleolus stress fracture following total ankle replacement, one metatarsal stress fracture not involving the surgery site, and one DVT. No reports of anchor pullout or soft tissue repair failure. VAS and FAOS scores improved from 6.2 to 1.2 and 54.3 to 93.9. Conclusion: In our review of 57 patients operated on with the SonicAnchor with at least two year followup, there were zero cases of complications stemming from the anchor including anchor pullout or soft tissue repair failure. Overall, patients improved tremendously in their clinical outcome scores across a wide range of different procedures. Previous studies have demonstrated the biomechanical strength of the SonicAnchor and our review supports its clinical safety and efficacy in long-term clinical followup.


2009 ◽  
Vol 30 (9) ◽  
pp. 836-841 ◽  
Author(s):  
Loretta B. Chou ◽  
Yvette Y. Ho ◽  
Martin M. Malawer

Background: Both primary and metastatic tumors in the foot and ankle have been reported as rare. The purpose of this study was to describe 153 cases of foot and ankle tumors from a 20-year experience in a tertiary referral center specializing in orthopaedic oncology. It is the largest reported series of both bone and soft tissue tumors in the foot and ankle. Materials and Methods: Between 1986 and 2006, a retrospective chart review was performed of a total of 2,660 tumors surgically treated in all anatomic sites by a single surgeon at a musculoskeletal tumor referral center. Results: One hundred fifty-three patients (5.75%) with bone and/or soft tissue tumors of the foot and ankle were treated. There were 84 women and 69 men. The patients' ages ranged from 1 to 84, with a median age of 30 and mean of 33.2. The tissue types included 80 soft tissue and 73 bone tumors. Overall, 60 (39.2%) were malignant, and 93 (60.8%) were benign. The most common diagnosis was giant cell tumor. In addition, giant cell tumor was the most common bone tumor, while pigmented villonodular synovitis and giant cell tumor of the tendon sheath were the most common soft tissue tumors. Conclusion: The incidence of tumors of the foot and ankle in this series of a single surgeon over a 20-year practice was 5.75%. The results of this study reaffirm that awareness, correctly diagnosing, and appropriately treating or referring to an orthopaedic oncologist may help with an improved outcome for patients. Level of Evidence: IV, Retrospective Case Series


2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0026
Author(s):  
Syed H. Hussaini ◽  
Daniel M. Dean ◽  
Michael Kelly ◽  
Daniel J. Cuttica

Category: Basic Sciences/Biologics; Ankle; Hindfoot; Midfoot/Forefoot; Sports Introduction/Purpose: Artelon is a synthetic degradable polyurethaneurea graft which has been investigated and utilized for soft tissue reconstruction in a variety of orthopaedic settings. However, in the field of foot and ankle surgery, there is very limited reported clinical data on outcomes of surgery utilizing Artelon. The goal of this study was look at outcomes of foot and ankle surgery in which Artelon is used, including post-op VAS scores and complications including adverse foreign body reaction, infection, repeat surgery, and implant failure. Our hypothesis was that soft tissue reconstruction procedures utilizing artelon will have a low complication rate, similar to established complication rates for other soft tissue reconstruction procedures such as those utilizing allograft, autograft, or other synthetic tissue. Methods: The treating surgeon’s first 55 consecutive patients 18 years and older who were treated with artelon graft as part of a foot and ankle surgery are being included in this IRB-approved study. Through retrospective chart review, outcome measures including the procedure for which artelon was utilized, pre and post-op Visual Analogue Scale (VAS) scores, and complications including repeat surgery for graft failure, foreign body reaction, wound healing issues, infection, and osteolysis were assessed. Statistical analysis was done utilizing Student’s t-test for continuous variables and chi square test for categorical variables. Results: Average follow-up time was 246.5 days. The majority of patients had artelon placed for spring ligament reconstruction, brostrom procedures, or achilles tendon reconstruction. VAS scores dropped significantly from before surgery to 3 weeks post- operatively (5.6 to 3.2, p<0.05). VAS scores stabilized after 3 weeks, with final follow-up score at 2.9. There were no reports of osteolysis in the area of the graft placement, adverse foreign body reaction, or episodes of graft failure. There were two major complications involving artelon surgical sites: one patient required a free flap for wound coverage, and another required an operative debridement with hardware and artelon removal, antibiotic spacer placement, and subsequent hindfoot fusion. Other minor complications not requiring operative intervention included cellulitis (3 patients) and delayed wound healing (5). Conclusion: Artelon is a safe and effective implant that can be utilized for soft tissue reconstruction in the foot and ankle, with similar post-operative pain recovery and wound complication rates compared to established historical data for these procedures. Additional studies must be done looking at long-term patient outcomes with utilization of artelon, and direct comparative studies with other soft tissue reconstruction techniques and materials in the foot and ankle.


2020 ◽  
Vol 40 (12) ◽  
pp. NP657-NP665
Author(s):  
Shahriyar Yahyavi ◽  
Hesam Jahandideh ◽  
Mehdi Izadi ◽  
Hamidreza Paknejad ◽  
Niousha Kordbache ◽  
...  

Abstract Background Although the number of cosmetic surgeries performed per year continues to increase, many candidates have skin problems. Thick-skinned rhinoplasty patients pose a real challenge for surgeons. Fear of performing surgery in patients with a history of isotretinoin use is another concern. Objectives The aim of this study was to study the effects of perioperative isotretinoin on rhinoplasty patient outcomes. Methods This research was conducted on 350 rhinoplasty patients, divided into control and experimental groups, between 2012 and 2015. The experimental group patients were requested to consume isotretinoin from 2 weeks before surgery to 2 months following the surgery. A comparison was made between the 2 groups 1, 3, 6, and 12 months after the surgery. Results Statistical tests indicated that the satisfaction of experimental group patients at months 1 and 3 following the surgery was significantly higher than that of control group patients (P &lt; 0.01). Examination of the patients’ noses found little evidence for soft tissue repair disturbance and cartilaginous deformities. Nine patients from the experimental group needed revision surgery during the study period, but none of the revision surgeries was for a cause clearly attributable to the intake of isotretinoin. Conclusions The results of this research suggest that isotretinoin causes no evident disturbance to the recovery of rhinoplastic incisions and internal nose structures. Moreover, none of the experimental group patients showed hypertrophic tissues and cartilaginous deformities, and the repair was satisfactory, similar to the control group. However, patients receiving isotretinoin were more satisfied with their operation outcomes and experienced fewer skin problems. Level of Evidence: 3


2020 ◽  
Vol 41 (12) ◽  
pp. 1487-1492
Author(s):  
Rona W. Law ◽  
Travis M. Langan ◽  
Devon W. Consul ◽  
James Steriovski ◽  
Mark A. Prissel ◽  
...  

Background: Foot and ankle surgery often requires bone healing, whether in elective arthrodesis or trauma. While primary bone healing is possible, the rate of nonunion in foot and ankle surgery remains variable. The addition of autogenous bone graft can allow for higher union rates by adding to the biology at the site of bone healing. Harvesting autogenous bone graft from the calcaneus for foot and ankle surgery can be done quickly and efficiently and allow for an adequate amount of graft. Methods: A retrospective chart and radiographic review was performed for 1438 patients at a single center between August 1, 2015, and December 15, 2018, who underwent calcaneal autograft harvesting using a power-driven reaming graft harvester. Results: In total, 966 patients were included and evaluated for the safety and complication rate associated with the procedure. Only 1 patient (0.1%) had a major complication, and there were 14 minor complications (1.4%). Conclusion: The safety profile and low complication rate of this case series demonstrate that this simple and efficient calcaneal autograft harvest technique can be considered when a small to moderate amount of autogenous bone graft is required to augment bone healing. Level of Evidence: Therapeutic level IV, case series.


Author(s):  
Amr Elbatawy ◽  
Mohammed Elgammal ◽  
Tarek Zayid ◽  
Abdelnaser Hamdy ◽  
Mohamed Osama Ouf ◽  
...  

Abstract Background Lower limb reconstruction is a well-recognized challenge to the trauma or plastic surgeon. Although techniques and outcomes in the adult population are well documented, they are less so in the pediatric population. Here, we present our experience in the management of posttraumatic foot and ankle defects with free tissue transfer in children. Methods We performed a retrospective analysis of 40 pediatric patients between the ages of 3 and 16 from 2008 to 2016 who underwent foot and ankle soft tissue reconstruction. Any patient who underwent reconstruction for any reason other than trauma was excluded. Data were collected on operative time, free tissue transfer type, use of vein grafts, length of hospital stay, and postoperative morbidity. Also, a comprehensive systematic literature review was completed according to the PRISMA protocol for all previous reports of foot and ankle reconstruction in the young age group with free tissue transfer. Results Of our 40 patients, 23 were males and 12 females, free tissue transfer was used to reconstruct primarily the dorsum (71%), heel (11%), medial (9%), and lateral (3%) aspect of the foot. The anterior tibial artery was the predominant recipient vessel for anastomosis (77%). Mean inpatient stay was 9 days and our complication rate was 20%, primarily of superficial infection treated with antibiotic therapy. The review of the literature articles is completely analyzed in detail. Conclusion The need for durable coverage of exposed joints, tendons, fractures, or hardware makes the free flap particularly well suited to trauma reconstruction of the foot and ankle. The lack of underlying vascular disease in this patient group allows for low complication rates. Our study evidences the safety and positive long-term outcomes of free tissue transfer for the reconstruction of huge sized-soft tissue defects of the foot and ankle in children.


2016 ◽  
Vol 38 (1) ◽  
pp. 27-35 ◽  
Author(s):  
Jessica H. Heyer ◽  
Donald J. Rose

Background: An os trigonum is a potential source of posterior ankle pain in dancers, often associated with flexor hallucis longus (FHL) pathology. Options for operative excision include open excision, subtalar arthroscopy, and posterior endoscopy. The purpose of this paper was to present a series of dancers who underwent excision of a symptomatic os trigonum via an open posteromedial approach. Methods: This study is a retrospective case series of 40 ankles in 38 dancers who underwent os trigonum excision via an open posteromedial approach with FHL tenolysis between 2000 and 2013. All patients were interviewed and charts retrospectively analyzed. Collected variables included pre- and postoperative pain level, time to return to dance, and subjective satisfaction. The average age was 19.2 years; ballet was the primary dance form in 36 (95%) of patient-cases. Eight (20%) of the patient-cases were professional dancers, and 30 (75%) were students or preprofessional dancers. Results: Average preoperative pain level was 7.7/10, which decreased to 0.6/10 postoperatively. Seventeen (42.5%) experienced concurrent preoperation-associated FHL symptomatology, all of whom experienced relief postoperatively. The average time to return to dance was 7.9 weeks, and time to pain-free dance was 17.7 weeks. Of the 37 patient-cases desiring to return to dance, 35 (94.6%) returned to their preoperative level of dance. There were no neurovascular or other major complications. Four (10%) had minor wound complications that resolved, and 38 cases (95%) considered the procedure a success. Conclusion: Open posteromedial excision of an os trigonum in dancers provided satisfactory pain relief, return to dance, and complication rates compared to other approaches, and allowed for identifying and treating any associated FHL pathology. Level of Evidence: Level IV, retrospective case series.


2018 ◽  
Vol 47 (13) ◽  
pp. 3277-3283 ◽  
Author(s):  
Huw Lloyd Morgan Williams ◽  
Jonathan Peter Evans ◽  
Nicholas Duncan Furness ◽  
Christopher David Smith

Background: The surgical treatment of recurrent shoulder instability has evolved in recent years to include a variety of soft tissue and bone block procedures, undertaken with either an open or arthroscopic approach. Although the utilization of such techniques has rapidly expanded, the associated risk of complications remains poorly defined. This information is vital for clinical decision making and patient counseling. Purpose: To quantify the complication rate associated with all types of surgery for anterior glenohumeral joint dislocation. Study Design: Systematic review. Methods: A systematic search was undertaken of studies reporting complications from anterior shoulder stabilization surgery. Inclusion criteria were studies published in English between 2000 and 2017 with a minimum 2-year follow-up. Methodological quality of the included studies was assessed with the Methodological Index for Non-Randomized Studies criteria. Complication rates for all undesirable events contributing to the patient outcome were extracted and cumulative rates calculated. Results: Out of 1942 references, 56 studies were included, totaling 4362 procedures among 4336 patients. Arthroscopic soft tissue repair had a complication rate of 1.6% (n = 2805). When repair was combined with arthroscopic remplissage, the rate was 0.5% (n = 219). Open soft tissue repair had a complication rate of 6.2% (n = 219) and open labral repair with remplissage, a rate of 2.3% (n = 79). An open bone block procedure had a complication rate of 7.2% (n = 573) and an arthroscopic bone block procedure, a rate of 13.6% (n = 163). Conclusion: This large systematic review demonstrates the overall complication rates (not purely recurrence rates) in modern shoulder stabilization surgery. With the growing interest in bone block stabilization procedures, including those performed arthroscopically, surgeons should be aware of the 10-fold increase in complications for these procedures over soft tissue arthroscopic surgery and counsel their patients accordingly.


2020 ◽  
Vol 41 (7) ◽  
pp. 834-838
Author(s):  
Oliver J. Gagné ◽  
Murray Penner ◽  
Kevin Wing ◽  
Andrea Veljkovic ◽  
Alastair S. Younger

Background: The operative procedure for a total ankle replacement (TAR) is intimately associated with the prosthetic design. The anterior and lateral approaches both have pros and cons regarding their respective soft tissue complications, osteotomy requirements, orientation of the bone cut, and gutter visualization. Although both have been studied independently, few reports have compared both in the same setting. The purpose of this retrospective study was to investigate the difference in reoperation rate after lateral or anterior approach ankle arthroplasty. We hypothesized that the anterior approach had a higher rate of wound complications. Methods: We evaluated data from a single center collected between 2014 and 2017, comprising a total of 115 total ankle replacements performed by 1 of 4 fellowship-trained foot and ankle surgeons. Reoperations were recorded as an operative report with classification by Canadian Orthopaedic Foot and Ankle Society (COFAS) Reoperations Coding System (CROCS). The index approach used was determined by the surgeon’s practice preference. Patients were included when they had a primary TAR in the time frame noted and had a complete data set up to at least 2 years after surgery. The cohort comprised 67 anterior and 48 lateral operations with balanced demographics for age (95% CI: 63-67 years) and gender (47% F). The lateral group had more complex cases with higher COFAS type arthritis (more periarticular arthritis and surrounding deformity). Results: Comparing the 2 groups, a total of 40 reoperations (7 anterior [A], 33 lateral [L]) occurred in 27 patients (5 A, 22 L). One patient had 4 related reoperations. The only revision was in the anterior group. The only soft tissue reconstruction was a split-thickness skin graft in the lateral group. Nine reoperations were irrigation debridement related to an infection or wound complication (3 A, 6 L). The majority (19/33) of reoperations in the lateral group were gutter debridement (8) or lateral hardware removal (11). Operative time was statistically different at 145 minutes (95% CI: 127-164 minutes) in anterior TAR and 178 minutes (95% CI: 154-202 minutes) for lateral TAR ( P = .0058). The odds ratio of having any reoperation with a lateral approach TAR was 6.19 compared to the anterior group. Conclusion: The results at the 2-year time point demonstrated that there were more reoperations after a lateral approach TAR than an anterior TAR, recognizing the significant case complexity imbalance between the groups and a corresponding relative increase in resource utilization of lateral TAR patients. The 2 implant designs were associated with different reoperation rates, favoring the anterior group. Change in the lateral fixation may have reduced the risk of repeat surgery. Level of Evidence: Level III, retrospective comparative series.


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