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Stone K.R.,The Foundation Stone | Walgenbach A.,The Foundation Stone | Galili U.,University of Massachusetts Medical School
Tissue Engineering - Part B: Reviews | Year: 2017

This review describes a novel method developed for processing porcine tendon and other ligament implants that enables in situ remodeling into autologous ligaments in humans. The method differs from methods using extracellular matrices (ECMs) that provide postoperative orthobiological support (i.e., augmentation grafts) for healing of injured ligaments, in that the porcine bone-patellar-tendon-bone itself serves as the graft replacing ruptured anterior cruciate ligament (ACL). The method allows for gradual remodeling of porcine tendon into autologous human ACL while maintaining the biomechanical integrity. The method was first evaluated in a preclinical model of monkeys and subsequently in patients. The method overcomes detrimental effects of the natural anti-Gal antibody and harnesses anti-non-gal antibodies for the remodeling process in two steps: Step 1. Elimination of α-gal epitopes - this epitope that is abundant in pigs (as in other nonprimate mammals) binds the natural anti-Gal antibody, which is the most abundant natural antibody in humans. This interaction, which can induce fast resorption of the porcine implant, is avoided by enzymatic elimination of α-gal epitopes from the implant with recombinant α-galactosidase. Step 2. Partial cross-linking of porcine tendon with glutaraldehyde - this cross-linking generates covalent bonds in the ECM, which slow infiltration of macrophages into the implant. Anti-non-gal antibodies are produced in recipients against the multiple porcine antigenic proteins and proteoglycans because of sequence differences between human and porcine homologous proteins. Anti-non-gal antibodies bind to the implant ECM, recruit macrophages, and induce the implant destruction by directing proteolytic activity of macrophages. Partial cross-linking of the tendon ECM decreases the extent of macrophage infiltration and degradation of the implant and enables concomitant infiltration of fibroblasts that follow the infiltrating macrophages. These fibroblasts align with the implant collagen fibers and secrete their own collagen and other ECM proteins, which gradually remodel the porcine tendon into human ACL. This ligamentization process lasts ∼2 years and the biomechanical integrity of the graft is maintained throughout the whole period. These studies are the first, and so far the only, to demonstrate remodeling of porcine tendon implants into permanently functional autologous ACL in humans. © Mary Ann Liebert, Inc. 2017.


Stone K.R.,The Stone Clinic | Stone K.R.,The Foundation Stone | Pelsis J.R.,The Foundation Stone | Crues J.V.,RadNet | And 3 more authors.
Knee | Year: 2014

Background: Revision of failed surgical treatments of osteochondritis dissecans (OCD) lesions remains a challenge without an obvious solution. The aim of this study was to evaluate seven consecutive patients undergoing osteochondral grafting of a failed OCD repair. Methods: The mean time from surgery to the latest evaluation was 7.0. years. IKDC, WOMAC, Tegner, and MRI studies were collected both preoperatively and during follow-up. Evaluation of the graft was assessed using the magnetic resonance observation of cartilage repair tissue (MOCART) grading system. Results: Over the course of the study period, five patients required additional surgery with a study median of one additional surgery (range, zero to 3). At most recent follow-up, there was significant improvement from preoperative values in median IKDC (p = 0.004), WOMAC (p = 0.030), and Tegner (p = 0.012). Complete cartilage fill and adjacent tissue integration of the paste graft were observed by MRI evaluation in five of the seven (71.4%) patients. Definitive correlation between clinical outcomes and MRI scores was not observed. Conclusions: This study shows promising results of osteochondral grafting as a viable option for the revision of failed OCD lesion repairs; however, more patients are needed to fully support its efficacy in these challenging failed revision cases. © 2014 Elsevier B.V.


Stone K.R.,The Foundation Stone | Pelsis J.R.,The Foundation Stone | Surrette S.T.,The Foundation Stone | Walgenbach A.W.,The Foundation Stone | Turek T.J.,The Foundation Stone
Knee Surgery, Sports Traumatology, Arthroscopy | Year: 2014

Methods: Forty-nine patients with moderate to severe cartilage damage who underwent meniscus allograft transplantation were included in this study; those with symptoms related to articular cartilage damage also underwent articular cartilage repair. Kaplan–Meier (KM) survival estimate, potential hazards to survival, and subjective clinical outcomes were analyzed. For KM survival, failure was defined as progression to knee arthroplasty, surgical removal of the meniscus transplant without revision, a self-reported follow-up pain level that was more than preoperative level, or constant moderate pain with no relief from non-operative treatment.Results: The mean follow-up time was 8.6 ± 4.2 years. The mean age at surgery was 45.3 ± 12.9 years. Meniscus transplantation was performed in 37 medial cases and 12 lateral cases. There were 41 patients with Outerbridge Grade IV and 8 with Grade III. Thirty-six (73.5 %) patients were able to participate in sporting activities postoperatively. Eleven (22.4 %) meniscus transplants failed at an average of 5.2 ± 4.4 years. The KM mean estimated survival time was 12.6 ± 0.7 years. No tested risks were found to affect sports participation or procedure success.Conclusions: Meniscus transplantation is a viable surgical option for patients with severe cartilage damage and missing or irreparable menisci to provide significant improvements in pain and function levels in the medium to long term with the majority of patients achieving their goal of participation in sporting activities. These results indicate that symptomatic patients may be able to participate in sports activities for an average of 12.6 years following meniscus transplantation.Level of evidence: Case series, Level IV.Purpose: The purpose of this study was to evaluate the efficacy of meniscus allograft transplantation in an active patient population with moderate to severe cartilage damage and the procedure’s ability to allow sports participation postoperatively. © 2014, European Society of Sports Traumatology, Knee Surgery, Arthroscopy (ESSKA).


Feuerstein J.D.,Beth Israel Deaconess Medical Center | Pelsis J.R.,The Foundation Stone | Lloyd S.,Beth Israel Deaconess Medical Center | Cheifetz A.S.,Beth Israel Deaconess Medical Center | Stone K.R.,The Foundation Stone
Seminars in Arthritis and Rheumatism | Year: 2016

Objective: To determine the validity of the hip and knee osteoarthritis guidelines. Methods: A systematic search of PubMed using a combination of Mesh and text terms with limitations to guidelines was performed to identify hip and knee osteoarthritis guidelines. The study was performed from April 17, 2014 to October 1, 2014. Guidelines were reviewed for graded levels of evidence, methods used to grade the evidence, and disclosures of conflicts of interest. Additionally, guidelines were also assessed for key quality measures using the AGREE II system for assessing the quality of guidelines. Results: A total of 13 guidelines relevant to the diagnosis and/or treatment of hip/knee osteoarthritis was identified. The 180 recommendations reviewed were supported by 231 pieces of evidence. In total, 35% (n = 80; range: 0-26) were supported by level A evidence, 15% (n = 35; range: 0-10) were by level B, and 50% (n = 116; range: 0-62) were by level C. Median age of the guidelines was 4 years (±4.8; range: 0-16) with no comments on planned updates. In total, 31% of the guidelines included patients in the development process. Only one guideline incorporated cost consideration, and only 15% of the guidelines addressed the surgical management of osteoarthritis. Additionally, 46% of guidelines did not comment on conflicts of interest (COI). When present, there was an average 29.8 COI. Notably, 82% of the COI were monetary support/consulting. Conclusions: In total, 50% of the hip/knee osteoarthritis guideline recommendations are based on lower quality evidence. Nearly half the guidelines fail to disclose relevant COI and when disclosed, multiple potential COI are present. Future hip/knee osteoarthritis guideline development committees should strive to improve the transparency and quality of evidence used to formulate practice guidelines. © 2015 Elsevier Inc.


Stone K.R.,The Foundation Stone | Adelson W.S.,The Foundation Stone | Pelsis J.R.,The Foundation Stone | Walgenbach A.W.,The Foundation Stone | Turek T.J.,The Foundation Stone
Journal of Bone and Joint Surgery - Series B | Year: 2010

We describe 119 meniscal allograft transplantations performed concurrently with articular cartilage repair in 115 patients with severe articular cartilage damage. In all, 53 (46.1%) of the patients were over the age of 50 at the time of surgery. The mean follow-up was for 5.8 years (2 months to 12.3 years), with 25 procedures (20.1%) failing at a mean of 4.6 years (2 months to 10.4 years). Of these, 18 progressed to knee replacement at a mean of 5.1 years (1.3 to 10.4). The Kaplan-Meier estimated mean survival time for the whole series was 9.9 years (SD 0.4). Cox's proportional hazards model was used to assess the effect of covariates on survival, with age at the time of surgery (p = 0.026) and number of previous operations (p = 0.006) found to be significant. The survival of the transplant was not affected by gender, the severity of cartilage damage, axial alignment, the degree of narrowing of the joint space or medial versus lateral allograft transplantation. Patients experienced significant improvements at all periods of follow-up in subjective outcome measures of pain, activity and function (all p-values < 0.05), with the exception of the seven-year Tegner index score (p = 0.076). ©2010 British Editorial Society of Bone and Joint Surgery.


Thomas K.,The Foundation Stone | Thomas K.,Guys Hospital | Smith N.C.,The Foundation Stone | Hegarty N.,The Foundation Stone | Glass J.M.,The Foundation Stone
Urology | Year: 2011

Objectives: To report the development and validation of a scoring system, the Guy's stone score, to grade the complexity of percutaneous nephrolithotomy (PCNL). Currently, no standardized method is available to predict the stone-free rate after PCNL. Methods: The Guy's stone score was developed through a combination of expert opinion, published data review, and iterative testing. It comprises 4 grades: grade I, solitary stone in mid/lower pole or solitary stone in the pelvis with simple anatomy; grade II, solitary stone in upper pole or multiple stones in a patient with simple anatomy or a solitary stone in a patient with abnormal anatomy; grade III, multiple stones in a patient with abnormal anatomy or stones in a caliceal diverticulum or partial staghorn calculus; grade IV, staghorn calculus or any stone in a patient with spina bifida or spinal injury. It was assessed for reproducibility using the kappa coefficient and validated on a prospective database of 100 PCNL procedures performed in a tertiary stone center. The complications were graded using the modified Clavien score. The clinical outcomes were recorded prospectively and assessed with multivariate analysis. Results: The Guy's stone score was the only factor that significantly and independently predicted the stone-free rate (P =.01). It was found to be reproducible, with good inter-rater agreement (P =.81). None of the other factors tested, including stone burden, operating surgeon, patient weight, age, and comorbidity, correlated with the stone-free rate. Conclusions: The Guy's stone score accurately predicted the stone-free rate after PCNL. It was easy to use and reproducible. © 2011 Elsevier Inc.


PubMed | The Foundation Stone and Beth Israel Deaconess Medical Center
Type: Journal Article | Journal: Seminars in arthritis and rheumatism | Year: 2016

To determine the validity of the hip and knee osteoarthritis guidelines.A systematic search of PubMed using a combination of Mesh and text terms with limitations to guidelines was performed to identify hip and knee osteoarthritis guidelines. The study was performed from April 17, 2014 to October 1, 2014. Guidelines were reviewed for graded levels of evidence, methods used to grade the evidence, and disclosures of conflicts of interest. Additionally, guidelines were also assessed for key quality measures using the AGREE II system for assessing the quality of guidelines.A total of 13 guidelines relevant to the diagnosis and/or treatment of hip/knee osteoarthritis was identified. The 180 recommendations reviewed were supported by 231 pieces of evidence. In total, 35% (n = 80; range: 0-26) were supported by level A evidence, 15% (n = 35; range: 0-10) were by level B, and 50% (n = 116; range: 0-62) were by level C. Median age of the guidelines was 4 years (4.8; range: 0-16) with no comments on planned updates. In total, 31% of the guidelines included patients in the development process. Only one guideline incorporated cost consideration, and only 15% of the guidelines addressed the surgical management of osteoarthritis. Additionally, 46% of guidelines did not comment on conflicts of interest (COI). When present, there was an average 29.8 COI. Notably, 82% of the COI were monetary support/consulting.In total, 50% of the hip/knee osteoarthritis guideline recommendations are based on lower quality evidence. Nearly half the guidelines fail to disclose relevant COI and when disclosed, multiple potential COI are present. Future hip/knee osteoarthritis guideline development committees should strive to improve the transparency and quality of evidence used to formulate practice guidelines.


PubMed | The Foundation Stone
Type: Journal Article | Journal: The Canadian journal of urology | Year: 2015

Calcification of the vas deferens and seminal vesicles is a rare condition of unknown incidence. It has been described in association with diabetes, hyperparathyroidism and genitourinary tuberculosis, amongst other conditions. Little is known about the clinical significance and management of this condition. We review the literature in an effort to find answers about an entity that is frequently appreciated as an incidental finding.An electronic database search was performed (Medline) using the key words: vas deferens; seminal vesicles; calcification, alone or in combination. Articles were selected according to relevance and quality of evidence.The search included published manuscripts between 1960 and 2012. A total of 17 relevant publications were identified. The majority were written in the English language and mostly consisted of case presentations and reports of radiologic findings.Calcification of the vas deferens and seminal vesicles is a rare condition. However, it may be implicated in male factor infertility and symptoms from the urogenital tract. Treatment should be directed towards the underlying cause on an individual basis. It is unknown whether control of the primary process has any effects on the histopathological appearance of the ducts and/or their improvement of function.


PubMed | The Foundation Stone
Type: Journal Article | Journal: Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA | Year: 2015

The purpose of this study was to evaluate the efficacy of meniscus allograft transplantation in an active patient population with moderate to severe cartilage damage and the procedures ability to allow sports participation postoperatively.Forty-nine patients with moderate to severe cartilage damage who underwent meniscus allograft transplantation were included in this study; those with symptoms related to articular cartilage damage also underwent articular cartilage repair. Kaplan-Meier (KM) survival estimate, potential hazards to survival, and subjective clinical outcomes were analyzed. For KM survival, failure was defined as progression to knee arthroplasty, surgical removal of the meniscus transplant without revision, a self-reported follow-up pain level that was more than preoperative level, or constant moderate pain with no relief from non-operative treatment.The mean follow-up time was 8.6 4.2 years. The mean age at surgery was 45.3 12.9 years. Meniscus transplantation was performed in 37 medial cases and 12 lateral cases. There were 41 patients with Outerbridge Grade IV and 8 with Grade III. Thirty-six (73.5%) patients were able to participate in sporting activities postoperatively. Eleven (22.4%) meniscus transplants failed at an average of 5.2 4.4 years. The KM mean estimated survival time was 12.6 0.7 years. No tested risks were found to affect sports participation or procedure success.Meniscus transplantation is a viable surgical option for patients with severe cartilage damage and missing or irreparable menisci to provide significant improvements in pain and function levels in the medium to long term with the majority of patients achieving their goal of participation in sporting activities. These results indicate that symptomatic patients may be able to participate in sports activities for an average of 12.6 years following meniscus transplantation.Case series, Level IV.


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