Human-engineered auricular reconstruction (hEAR) by 3D-printed molding with human-derived auricular and costal chondrocytes and adipose-derived mesenchymal stem cells

Microtia is a small, malformed external ear, which occurs at an incidence of 1-10 per 10,000 births. Autologous reconstruction using costal cartilage is the most widely accepted surgical microtia repair technique. Yet, the method involves donor-site pain and discomfort and relies on the artistic skill of the surgeon to create an aesthetic ear. This study employed novel tissue engineering techniques to overcome these limitations, by developing a clinical-grade, 3D-printed biodegradable auricle scaffold that formed stable, custom-made, neocartilage implants. The unique scaffold design combined strategically reinforced areas to maintain the complex topography of the outer ear and micropores to allow cell adhesion for the effective production of stable cartilage. The auricle construct was CT scan-based composed of a 3D-printed clinical-grade polycaprolactone (PCL) scaffold loaded with patient‐derived chondrocytes produced from either auricular cartilage or costal cartilage biopsies combined with adipose-derived MSCs. Cartilage formation was measured within the construct in vitro, and cartilage maturation and stabilization were observed 12 weeks after its subcutaneous implantation into a murine model. The proposed technology is simple and effective and is

803 Management of An Intra-Oral Resection with Integra® Dermal Regeneration Template – Worth A Bite?

Introduction There are a spectrum of treatment options available for reconstruction of oral mucosal defects including secondary healing, skin grafts, local flaps and microvascular free flaps. We present the use of an alternative intra-oral reconstruction with Integra® Dermal Regeneration Template. Case Report An 85-year-old patient with a severe gag reflex and history of oral cancer presented with biopsy proven severe dysplasia of the right palate extending to the hamular notch. She was treated with wide local excision, extraction of teeth, buccal fat pad advancement for closure of an oral-antral communication and placement of Integra® Dermal Regeneration Template. Discharge was possible the same day as the patient was able to eat and had minimal pain. Discussion Integra® Dermal Regeneration Template is a bilayer wound matrix consisting of silicone in the outer layer with bovine collagen and glycosaminoglycan from shark cartilage in the inner layer. Oral cancer predominantly affects the older population, and this method can reduce surgical time, remove donor site pain, reduce post-operative pain and avoid use of a cover plate where a strong gag reflex was present. The area heals quickly and aids quick restoration of oral function. Conclusion Integra® Dermal Regeneration Template has been used for head and neck defects with good outcomes. It is being increasingly used intra-orally with good outcomes, suggesting a further application of the material with advantages over traditional techniques in specific patient groups.

Minimal graft site morbidity using autogenous semitendinosus graft from the uninjured leg: a randomised controlled trial

Purpose To quantify the effect on strength of semitendinosus (ST) graft harvest by comparing isokinetic and isometric muscle strength. Methods A cohort of 140 patients underwent anterior cruciate ligament (ACL) reconstruction (ACLR) and were randomized to ipsilateral or contralateral ST graft harvest. Isokinetic and isometric muscle strength testing using a dynamometer were collected for the operated and non-operated leg. Patients were assessed pre-surgery and at 6, 12 and 24 months after reconstruction. Results ST graft harvest reduced isokinetic flexion muscle strength for 6 months. At 12 months follow up there was no significant difference between the two groups and they were all stronger than pre-injury. No other significant differences were found in any primary or secondary outcome measurements. Conclusion Solitary ST graft harvest does not appear to result in a permanent reduced isometric or isokinetic quadriceps muscle strength on the side where the graft is harvested. A reduction in hamstring muscle strength of less than 10% can be seen at short-term follow-up with full recovery by 12 months. Most patients report little or no donor site pain. Given these findings, ST autograft is an alternative graft choice that could be used for various reconstructions in terms of donor site morbidity. Level of evidence Level II.

Calcaneal Reconstruction With Free Deep Circumflex Iliac Artery Osseocutaneous Flap Following Aggressive Benign Bone Tumor Resection

Background: Advances in limb-salvage techniques have made total calcanectomy and primary reconstruction possible in managing calcaneal aggressive benign tumors and selected cases of intraosseous malignant tumors. However, there is still no consensus on the operative approach, oncologic margin, and the best reconstruction method to date. These 2 cases describe our experience in calcaneal reconstruction with the free deep circumflex iliac artery (DCIA) osseocutaneous flap in benign aggressive calcaneal tumors. Methods: We reported 2 consecutive male and female patients, with an average age of 25 years (age 19 and 31, respectively), who underwent total calcanectomy and primary calcaneal reconstruction with the free DCIA osseocutaneous flaps for calcaneal chondroblastoma and giant cell tumor. A marginal resection of the entire calcaneus through the subtalar and calcaneocuboid joints (intra-articular approach) was performed in the first case and a wide local resection leaving 1 cm normal calcaneal bone margin anterosuperiorly (intraosseous approach) was performed in the second case. Results: The follow-up period averaged 48 months. Negative oncologic margins were achieved in both cases. The first case was complicated with venous thrombosis; however, the graft remained viable after emergency reexploration. Normal foot function was restored with good solid osseous union and bony hypertrophy observed. Both patients achieved good short-term functional and aesthetic outcomes with no donor site pain or disability. No local recurrence was reported either. Conclusion: Primary calcaneal reconstruction with the free DCIA osseocutaneous flap can lead to good short-term functional and aesthetic outcomes. Level of Evidence: Level IV, case series.

Evaluation of Liposomal Bupivacaine at Split Thickness Skin Graft Donor Sites Through a Randomized, Controlled Trial

Split thickness skin grafts (STSG) are commonly required in reconstructive surgery but may cause significant pain. The goal of this investigator-initiated trial is to evaluate the effect of liposomal bupivacaine on donor site pain and opioid consumption. A parallel, randomized, controlled trial of adult acute burn patients with <20% total body surface area burns (TBSA) was conducted to evaluate the efficacy of liposomal bupivacaine at STSG donor sites. The control group received standard subcutaneous infiltration of dilute lidocaine solution at the STSG donor site, and the experimental group received dilute liposomal bupivacaine infiltration in a similar fashion. Donor site pain scores and opioid consumption in morphine equivalents (MEE) were evaluated. A total of 25 patients were enrolled in each group. There were no statistical differences in demographic variables, and TBSA was 4.0% in both groups (p=.94). There were no statistical differences in pain scores at any time point postoperatively (mean control range 3.1/10-4.9/10, experimental range 3.3/10-4.3/10, p=.12-.96). There were no statistical differences in opioid consumption at 24, 48, or 72 hours postoperatively between the groups (mean control MEE range 49.3-71.1, experimental MEE range 63.6-75.8, p=.34-.85). The average length of stay was 7.7 days in both groups (p=.88). No adverse events occurred in either group. There is no statistical benefit to the use of liposomal bupivacaine for infiltration at STSG donor sites compared to standard of care with respect to pain control, opioid use, or length of stay when evaluated in a randomized, controlled fashion.

ANTERIOR CRUCIATE LIGAMENT RECONSRUCTION IN CHILDREN: OUTCOMES OF QUADRICEPS VERSUS HAMSTRING AUTOGRAFTS

Background: Emerging evidence has suggested reduced donor site pain and equivalent/improved functional outcomes in adults undergoing ACL reconstruction (ACLR) with quadriceps (QT) autograft versus hamstrings (HT) grafts. No studies in children comparing QT versus HT autografts have assessed postoperative strength or active range of motion (AROM) in addition to more commonly accepted patient-reported outcome measures (PROMs). Hypothesis/Purpose: The purpose of this study was to directly compare clinical and patient-reported outcomes of pediatric patients undergoing QT and HT autograft ACL reconstructions. We hypothesized that use of QT autografts would result in similar clinical and PROMs to HT autografts. Methods: A retrospective cohort analysis of pediatric patients (≤18 years) undergoing primary transphyseal ACLR from 1/2018-12/2019 without concomitant multiligamentous reconstruction was conducted. Outcomes at 3 and 6 months, including isokinetic strength testing, PROMIS and IKDC scores, and AROM were compared between patients receiving either HT or QT autografts. Hamstrings to quadriceps (H/Q) ratios were calculated using the ratio of the respective peak torque values normalized to body weight. Multiple imputation was utilized to minimize bias resulting from missed follow-up appointments. Results: 84 patients met inclusion criteria (Table 1). The 40 patients receiving QT were more often male (62.5% vs 34.1%, p=0.009). There were no differences in operative time (p=0.053) or proportion of patients requiring meniscus repair (p=0.958). At 3 months postoperative, those with HT had lower H/Q ratios (62.2 ± 15.8 vs 78.6 ± 19.9, p<0.001) and limb symmetry index (LSI) in flexion (86.1 ± 17.1 vs 94.3 ± 17.6, p=0.042), while patients with QT had lower LSI in extension (66.8 ± 13.2 vs 77.3 ± 12.6, p=0.001). The H/Q ratio was also lower at 6 months among patients receiving HT (59.7 ± 11.2 vs 66.3 ± 8.2, p=0.004). IKDC, PROMIS physical function, and PROMIS pain interference scores were not different between cohorts at either 3 or 6 months. There was no difference in AROM in flexion or extension between groups at all postoperative visits. Patients with QT were more likely to have a postoperative wound issue (20.0% vs 2.3%, p=0.012). Conclusion: Significant differences in quadriceps and hamstrings strength at 3 months were observed for ACLR patients by graft type. This contributed to higher H/Q ratios at 3 and 6 months postoperatively for patients receiving QT. QT grafts appear to have a higher rate of postoperative infection/wound issues. Tables/Figures: [Table: see text]

31 A phase 3 open-label, controlled, randomized trial evaluating the efficacy and safety of a bioengineered allogeneic cellularized construct in patients with deep partial-thickness thermal burns

Introduction Autograft (AG) is the standard of care for treatment of severe burns. While AG provides effective wound closure (WC), the procedure creates a donor site wound prone to pain and scarring. In a phase 1b trial, no deep partial-thickness (DPT) wound treated with a bioengineered allogeneic cellularized construct (BACC) required AG by Day 28 and WC at the BACC site was achieved in 93% of patients by Month (M) 3. This phase 3 study (NCT03005106) evaluated the efficacy and safety of this BACC in patients with DPT burns. Methods Enrolled patients were aged ≥18 years with 3–49% TBSA thermal burns on the torso or extremities. In each patient, two DPT areas (≤2,000 cm2 total) deemed comparable following excision were randomized to treatment with either cryopreserved BACC or AG. Coprimary endpoints were 1) the difference in percent area of BACC treatment site and AG treatment site autografted at M3 and 2) the proportion of patients achieving durable WC of the BACC treatment site without AG at M3. Ranked secondary endpoints were: 1) the difference between BACC and AG donor sites in average donor site pain intensity through Day 14; 2) the difference between BACC and AG donor site cosmesis at M3; and 3) the difference between BACC and AG treatment site cosmesis at M12. Safety assessments were performed in all patients through M12. Results Seventy-one patients were enrolled. By M3, there was a 96% reduction in mean percent area of BACC treatment sites that required AG, compared with AG treatment sites (4.3% vs 102.1%, respectively; P&lt;.0001). BACC treatment resulted in durable WC at M3 without AG in 92% (95% CI: 85.6, 98.8; 59/64) of patients for whom data was available. By M3, mean donor site Patient and Observer Scar Assessment Scale (POSAS) observer total score (±SD) was significantly lower (more like normal skin) for BACC donor sites compared with AG donor sites (6.3 ± 1.71 vs 16.3 ± 7.71; P&lt;.0001). At M12, mean POSAS observer total score (±SD) was 15.6 (± 8.34) for BACC treatment sites compared with 16.3 (± 9.41) for AG treatment sites (P=.4268). The most common BACC-related adverse event (AE) was pruritus, which occurred in 11 (15%) patients. All BACC-related AEs were mild or moderate in severity. Conclusions This phase 3 study achieved both coprimary endpoints, including significant autograft sparing and durable WC in DPT burns. Both donor site pain and donor site cosmesis were favorable outcomes of significantly reduced use of AG in BACC-treated patients. M12 POSAS for BACC did not differ significantly from AG. This BACC may offer a new treatment for severe burns to reduce or eliminate the need for AG. Applicability of Research to Practice This BACC has shown clinical benefit in patients with DPT thermal burns, potentially mitigating donor site morbidity. External Funding Stratatech, a Mallinckrodt Company; Funding and technical support for the Phase 3 clinical study were provided by the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services, under Project BioShield Contract No. HHSO100201500027C.

More weighted cancellous bone can be harvested from the proximal tibia with less donor site pain than anterior iliac crest corticocancellous bone harvesting: retrospective review

Background Iliac crest is the most preferred autogenous bone graft harvesting donor site while it has sorts of complications like prolonged pain, hematoma, and fracture. Harvesting cancellous bone from proximal tibia is also increasingly being used because of lower complications and less donor site pain. However, there are lack of studies to compare these two donor sites in detail. Thus, we proposed to investigate the available amount of autogenous bone graft from the proximal tibia. Methods Fifty-one patients who underwent simultaneous bone graft harvest from the PT and the AIC to fill up the given critical sized bone defects were enrolled in this study. We prospectively collected data including the weight of the harvested bone, donor site pain using the visual analog scale (VAS) score, and complications between the two sites. Results The mean weight of cancellous bone harvested from the PT was greater than AIC (33.2g vs. 27.4g, p = 0.001). The mean VAS score was significantly lesser in the PT up to 60 days after harvesting (p < 0.001). There was persistent pain up to 90 days in four PT patients and in seven AIC patients. The major complication was reported only in AIC patients (11.8%). Conclusions Harvesting cancellous bone from the PT is an acceptable alternative to the AIC for autogenous bone grafting owing to availability of more weighted graft bone and less donor site pain.

FUNCTIONAL OUTCOME OF MODIFIED PUTTI PLATT PROCEDURE IN RECURRENT DISLOCATION OF SHOULDER – A RETROSPECTIVE ANALYSIS

Hand, which is considered to be an extension of brain and a tool for the execution of human intellect and will, owes much to the versatility of the movement of the shoulder for its placement on the desired spot of action. The shoulder, by virtue of its anatomy and biomechanics, is one of the most unstable and frequently dislocated joints, accounting for nearly 50% of all dislocations. Most of the recurrent dislocations of shoulder (96%) follow an initial signicant traumatic dislocation. There are two basic types of surgical approaches for shoulders with anterior instability: "anatomic" and "non-anatomic" repairs. With anatomic repairs, the goals are to restore the labrum toits normal position and to reestablish the appropriate tension in the shoulder capsule and ligaments. The goal of non-anatomic surgical procedures is to stabilize the shoulder by compensating for the capsulolabral and osseous injury with an osseous or soft-tissue checkrein that blocks excessive translation and restores stability. In Modied Putti Platt procedure, as done in our institute, after proper positioning and adequate exposure, the subscapularis muscle and capsule is incised at the musculotendinous junction. Aquadrangular unicortical graft, harvested from the iliac crest, is inserted fully into the trough made in the anterior glenoid, resulting in deepening of the glenoid articular surface. Subscapularis and the capsule are closed by double breasting, keeping the arm in external rotation. We did a retrospective analysis to assess the outcome of this procedure done in our institute. 102 patients were assessed and the required data were collected using hospital medical records, telephonic interview and direct clinicoradiological assessment. All the patients had positive apprehension test, pre- operatively. The mean Rowe score was 30.98 (standard deviation 5.846). The mean follow up duration was 44.52 months. 91 patients (89.2%) had no pain at last follow up duration and the rest had slight and occasional pain. All the patients were able to work above shoulder. The mean external rotation at 6 months follow up was 37.89° (SD 9.239), which increased to 65.88° (SD 8.967) at last follow up. The mean internal rotation at 6 months follow up was 61.18° (SD 4.623), which increased to 77.16° (SD 6.234) at last follow up. There was signicant improvement of Rowe's score post-operatively when compared to pre-operative Rowe's score. There was a signicant mean increase of 49.216 points post operatively with a correlation coefcient of +0.513. (p<0.05). All patients, at last follow up had a UCLA score of more than 27, with 96 patients (94.1%) had good clinical outcome (according to UCLA grading system). 6 patients had fair clinical outcome. 77 patients (75.5 %), according to Rowe score had good clinical outcome.12 patients (11.8%) had excellent outcome. 13 patients had fair clinical outcome. None of the patients who were operated in our institute had recurrence of dislocation. None of them were reoperated. 91 patients (89.2%) had negative apprehension with no evidence of subluxation. 10 patients (9.8%) had negative apprehension, but slight discomfort in abduction and external rotation. One person had positive apprehension test, but he was able to continue his activities of daily living and continued to engage in professional non contact sports, though at one level below; and he did not choose to undergo a reoperation. 6 patients, all aged more than 45 years, had clinicoradiological evidence of mild arthrosis of the shoulder joint. They are being treated conservatively with physical therapy and analgesics Mild donor site pain was there in 6 patients in the rst yr of surgery. This subsided with time with analgesics. None had evidence of donor site infection, and none had evidence of visceral injuries.

Novel bone grafting technique in stand-alone ALIF procedure combining allograft and autograft (‘Northumbria Technique’)—Fusion rate and functional outcomes in 100 consecutive patients

Introduction Successful ALIF surgery depends upon achieving solid fusion, whilst avoiding significant complications. Herein, we present the ‘Northumbria Technique’ of combining allograft with autograft in order to achieve solid interbody fusion. Materials and Methods A single-surgeon series of 100 consecutive patients undergoing stand-alone ALIF from 2016 to 2019 was studied. All had percutaneously harvested iliac crest bone graft (ICBG) dowels inserted into blocks of fresh frozen femoral head (FFFH) allograft, which were then inserted into the ALIF cages. Patients had dynamic radiographs at 4 months, CT at 6 months, and patient reported outcome measure scores (PROMS) throughout. Results One hundred patients (average age 44.8 years) were followed-up for an average of 29.1 months. Ninety-four (94%) patients were assessed as having fused on both CT and radiographs by an independent Radiologist. Three (3%) patients had abolition of movement on radiographs, but either lacked a CT scan or failed to meet Williams criteria for fusion. Two patients failed to attend for any imaging, so were considered not fused, and one patient had no evidence of fusion in either modality. There was a significant improvement in all PROMS. There were no intra-operative complications, and one patient had transient donor-site pain. Conclusions The newly described ‘Northumbria Technique’ utilises the osteoconductive characteristics of the FFFH allograft, as well as the osteoinductive and osteogenic properties of the ICBG autograft. It gives high fusion rates (94–97%) and statistically significant improvements in PROMS, whilst avoiding the complications of harvesting a large amount of autograft and the huge costs of using synthetic agents.