Two Year Clinical Outcomes of the Subchondroplasty® Procedure for Treatment of Symptomatic Bone Marrow Lesions of the Knee

Objectives: Bone Marrow Lesions (BML) are a common finding on knee MRI. In the knee, BML have a strong correlation to patient-reported pain, function, joint deterioration and rapid progression to TKR. Histologic analyses of BML have demonstrated findings consistent with fracture and bony remodeling of the trabeculae. The Subchondroplasty (SCP®) Procedure aims to treat the bone defects present in the BML by percutaneously filling them with a bone substitute material, designed to flow through intact bone, harden at body temperature and then heal through natural bone turnover. Previous retrospective, single-center case series have demonstrated improvements in patient-reported outcomes. The purpose of this prospective, multi-center study is to evaluate the 2-year clinical and radiographic outcomes of patients with BML of the knee treated with the Subchondroplasty Procedure. Methods: Seventy patients were treated between 2012 and 2017 for BML of the tibial plateau and/or femoral condyle. Self-drilling cannulas were inserted into the BML using arthroscopic and fluoroscopic guidance, then injected with AccuFill® Bone Substitute Material. All patients also underwent arthroscopy to aid in targeting the underlying bony lesion and address intra-articular pathology. MRIs and radiographs were obtained pre-operatively, at 6, 12 and 24 months, with additional radiographs collected at 6 weeks and 3 months. Patient-reported outcomes, including VAS pain, IKDC and KOOS were collected pre-operatively, 2 and 6 weeks, and 3, 6, 12 and 24 months post-operatively. Results: Seventy patients (36 males and 34 females), average age 57 were consented and enrolled in the study. Preoperative K-L grade included 1.4% Grade 0, 2.9% Grade 1, 27.1% Grade 2, 55.7% Grade 3 and 7.1% Grade 4. Fifty eight tibial plateaus and 41 femoral condyles were treated (29 bipolar lesions treated). VAS Pain scores improved from a mean of 6.2/10 pre-op to 2.9/10 at 1 year. IKDC scores improved from mean 33.9 pre-op to 61.3 at 1 year. KOOS scores improved from baseline to 1 year (Fig. 1) with mean KOOS Pain from 45.8 to 73.9, ADL 52.9 to 79.2, Symptoms 49.7 to 71.9, Sports 21.2 to 49.9 and Quality of Life 18.1 to 52.3. All patient-reported outcomes showed statistically significant improvement at one year. Two year outcomes collected to date appear to follow the same trend. The last study subject is due to return in January 2019 at which point the final 2 year analysis will be completed. Six patients (8.6%) converted to arthroplasty (1 UKA and 5 TKA) at one year. To date, the 24 month conversion rate is 16.1% out of 62 subjects. The final conversion rate for 24 months will be calculated after the final subject returns. Radiographs and MRIs demonstrated good incorporation of the AccuFill material through 12 months with evidence of early remodeling and a lack of OA progression in the majority of subjects. Twenty-four month MRIs demonstrate continued remodeling of the AccuFill material. Conclusion: This study presents statistically and clinically-meaningful evidence of improvements in clinical outcomes following Subchondroplasty procedure for BML of the knee. The low conversion rate suggests this less-invasive procedure may delay the need for knee arthroplasty. MR imaging demonstrates good incorporation of the BSM and evidence of remodeling and reduction in material volume over time. [Figure: see text][Table: see text]

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The Treatment of Bone Marrow Lesions Associated with Advanced Knee Osteoarthritis: Comparing Intraosseous and Intraarticular Injections with Bone Marrow Concentrate and Platelet Products

January 2018 - Pain Physician ◽

10.36076/ppj.2021/24/e279 ◽

2021 ◽

pp. E279-E288

Author(s):

Ehren Dodson

Keyword(s):

Bone Marrow ◽

Knee Osteoarthritis ◽

Patient Reported Outcomes ◽

Platelet Rich Plasma ◽

Intraarticular Injection ◽

Bone Marrow Concentrate ◽

Bone Marrow Lesions ◽

Treatment Groups ◽

Patient Reported ◽

Intraosseous Injection

Background: Bone marrow lesions are a radiographic indication of bony pathology closely associated with advanced osteoarthritis of the adjacent joint. Injection of autologous orthobiologic products, including bone marrow concentrate and platelet-rich plasma, have demonstrated safety and efficacy in treating both advanced osteoarthritis (via intraarticular injection) and associated bone marrow lesions (via intraosseous injection). The relative efficacy of intraarticular versus intraosseous injection of orthobiologics has not been evaluated at the present time. Objectives: The objective was to evaluate differences in orthobiologic bone marrow lesions treatment, either as a collateral result of intraarticular injection with bone marrow concentrate and platelet products alone, or intraosseous plus intraarticular injection as measured by patient reported outcomes. Study Design: This study employed a prospective case-matched cohort design. Setting: This study took place at a single outpatient interventional orthopedic pain clinic. Methods: Using data from a prospective orthobiologic treatment registry of knee patients, a population of knee osteoarthritis with bone marrow lesions patients who had undergone only intraarticular knee injections of bone marrow concentrate and platelets (for symptomatic advanced osteoarthritis) were age, gender, and disease severity case-matched to a series of advanced osteoarthritis and bone marrow lesions patients who underwent intraosseous plus intraarticular injections. Self-reported patient outcomes for Numeric Pain Scale, International Knee Documentation Committee, lower extremity functional scale, and a modified single assessment numeric evaluation were compared between the 2 treatment groups. Results: Eighty patients were included, 40 in each group. Although pain and functional outcome scores were significantly improved in both treatment groups, there was no statistically significant differences in patient reported outcomes based on the type of treatment. Limitations: There are several limitations to this study, including multiple providers performing the injections, varying onset of symptoms to treatment, and additional injections after their initial treatment, that were not controlled. In addition, increasing the sample size may be beneficial as well, particularly with the large bone marrow lesions group, which did suggest possible improvement with intraosseous plus intraarticular over the intraarticular, although was not statistically significant in our sample. Limited data availability for this cohort as well as some missing data are other limitations to consider. Conclusion: Treating knee bone marrow lesions with intraosseous bone marrow concentrate and platelet products did not affect patient reported outcomes. Key words: Intraosseous, intraarticular, bone marrow concentrate, bone marrow lesion, bone marrow edema, knee osteoarthritis, platelet-rich plasma, injection

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Comparison of Patient Reported Outcomes (PROs) for Major Pathologies of the Forefoot, Midfoot, Hindfoot, and Achilles Using PROMIS

Foot & Ankle Orthopaedics ◽

10.1177/2473011420s00263 ◽

2020 ◽

Vol 5 (4) ◽

pp. 2473011420S0026

Author(s):

Daniel A. Hu ◽

Rusheel Nayak ◽

Elijah O. Ogunkoya ◽

Milap Patel ◽

Anish R. Kadakia

Keyword(s):

Physical Function ◽

Clinical Outcomes ◽

Patient Reported Outcomes ◽

Postoperative Outcomes ◽

Anatomical Location ◽

Foot And Ankle ◽

Patient Reported ◽

Pain Outcomes ◽

One Year ◽

One Way Anova

Category: Other; Hindfoot; Midfoot/Forefoot Introduction/Purpose: Many legacy patient reported outcomes (PROs) lack sufficient validity and reliability for the evaluation of clinical outcomes following foot and ankle procedures. Patient-Reported Outcomes Measurement Information System (PROMIS) is a newly developed PRO that has been validated for the general foot and ankle surgical population. It has since been used to assess the clinical outcomes of a variety of specific foot and ankle procedures. However, there is little data regarding clinical outcomes of patients at a more intermediate subgroup level. There has been some preconceptions that the different anatomic aspects of foot and ankle surgery have disparate functional and pain improvement. Thus, our study utilizes PROMIS to assess postoperative outcomes based on anatomical location in patients undergoing forefoot, midfoot, hindfoot, and Achilles procedures. Methods: Preoperative and one year postoperative PROMIS Physical Function (PF) and Pain Interference (PI) were prospectively collected from a cohort of patients undergoing a foot and ankle procedure at a tertiary medical center. The cohort was split into forefoot, midfoot, hindfoot, and Achilles procedure groups with 355, 95, 356, and 135 patients, respectively. Paired-t tests were used to compare preoperative versus postoperative outcomes within operative groups, while a one-way ANOVA was used to detect differences in PROMIS scores between operative groups. Results: Paired t-tests indicated that all four operative groups had significantly improved PROMIS PF and PI scores preoperatively versus one year postoperatively (all P <.001)(see attached figure). One-way ANOVA demonstrated that there were no differences in postoperative PROMIS PF and PI scores between the groups. A majority of patients achieved the minimal clinically important difference (MCID) level of improvement in PROMIS PF and PI scores following surgery. Conclusion: All four operative groups (forefoot, midfoot, hindfoot, Achilles) had significantly improved PROMIS PF and PI scores postoperatively compared to preperatively, indicating an improvement in physical function and pain outcomes in each of the operative groups. However, there were no differences in physical function and pain outcomes between the groups. [Table: see text]

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In Vivo Analysis of the Biocompatibility and Bone Healing Capacity of a Novel Bone Grafting Material Combined with Hyaluronic Acid

International Journal of Molecular Sciences ◽

10.3390/ijms22094818 ◽

2021 ◽

Vol 22 (9) ◽

pp. 4818

Author(s):

Annica Pröhl ◽

Milijana Batinic ◽

Said Alkildani ◽

Michael Hahn ◽

Milena Radenkovic ◽

...

Keyword(s):

Bone Substitute ◽

Sham Operation ◽

Bone Substitute Material ◽

Water Binding ◽

Sham Operation Group ◽

Operation Group ◽

Substitute Material ◽

Tissue Reactions ◽

Inflammatory Tissue

The present in vivo study analyses both the inflammatory tissue reactions and the bone healing capacity of a newly developed bone substitute material (BSM) based on xenogeneic bone substitute granules combined with hyaluronate (HY) as a water-binding molecule. The results of the hyaluronate containing bone substitute material (BSM) were compared to a control xenogeneic BSM of the same chemical composition and a sham operation group up to 16 weeks post implantationem. A major focus of the study was to analyze the residual hyaluronate and its effects on the material-dependent healing behavior and the inflammatory tissue responses. The study included 63 male Wistar rats using the calvaria implantation model for 2, 8, and 16 weeks post implantationem. Established and Good Laboratory Practice (GLP)-conforming histological, histopathological, and histomorphometrical analysis methods were conducted. The results showed that the new hyaluronate containing BSM was gradually integrated within newly formed bone up to the end of the study that ended in a condition of complete bone defect healing. Thereby, no differences to the healing capacity of the control BSM were found. However, the bone formation in both groups was continuously significantly higher compared to the sham operation group. Additionally, no differences in the (inflammatory) tissue response that was analyzed via qualitative and (semi-) quantitative methods were found. Interestingly, no differences were found between the numbers of pro- and anti-inflammatory macrophages between the three study groups over the entire course of the study. No signs of the HY as a water-binding part of the BSM were histologically detectable at any of the study time points, altogether the results of the present study show that HY allows for an optimal material-associated bone tissue healing comparable to the control xenogeneic BSM. The added HY seems to be degraded within a very short time period of less than 2 weeks so that the remaining BSM granules allow for a gradual osteoconductive bone regeneration. Additionally, no differences between the inflammatory tissue reactions in both material groups and the sham operation group were found. Thus, the new hyaluronate containing xenogeneic BSM and also the control BSM have been shown to be fully biocompatible without any differences regarding bone regeneration.

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Radiographic evaluation of a bone substitute material in alveolar ridge preservation for maxillary removable immediate dentures: A randomized controlled trial

Journal of Prosthetic Dentistry ◽

10.1016/j.prosdent.2021.02.013 ◽

2021 ◽

Author(s):

Christophe Rignon-Bret ◽

Claudine Wulfman ◽

Fabien Valet ◽

Alain Hadida ◽

Thien-Huong Nguyen ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Bone Substitute ◽

Controlled Trial ◽

Radiographic Evaluation ◽

Ridge Preservation ◽

Alveolar Ridge ◽

Bone Substitute Material ◽

Randomized Controlled ◽

Alveolar Ridge Preservation ◽

Substitute Material

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Relationship Between Patient-Reported Outcomes and Clinical Outcomes in Patients With Morquio A Syndrome

Journal of Inborn Errors of Metabolism and Screening ◽

10.1177/2326409815576188 ◽

2015 ◽

Vol 3 ◽

pp. 232640981557618 ◽

Cited By ~ 7

Author(s):

Christina Lampe ◽

Mohit Jain ◽

Andrew Olaye ◽

Bianca Meesen ◽

Celeste Decker ◽

...

Keyword(s):

Clinical Outcomes ◽

Patient Reported Outcomes ◽

Morquio A ◽

Patient Reported ◽

Morquio A Syndrome

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The use of solvent-preserved human and bovine cancellous bone blocks for lateral defect augmentation - an experimental controlled study in vivo

Head & Face Medicine ◽

10.1186/s13005-021-00275-1 ◽

2021 ◽

Vol 17 (1) ◽

Author(s):

Lara Schorn ◽

Tim Fienitz ◽

Kathrin Berndsen ◽

Norbert R. Kübler ◽

Henrik Holtmann ◽

...

Keyword(s):

Bone Formation ◽

Cancellous Bone ◽

Bone Substitute ◽

Bone Matrix ◽

Human Bone ◽

Controlled Study ◽

Bovine Bone ◽

New Bone Formation ◽

Bone Substitute Material ◽

Substitute Material

Abstract Background The aim of this study was to compare new bone formation, resorbed bone matrix, and fibrous enclosed residual bone substitute material in laterally augmented alveolar bone defects using allogeneic, pre-treated and cleaned human bone blocks (tested in dogs, therefore considered to be xenogeneic), and pre-treated and cleaned bovine cancellous bone blocks, both with and without a collagen membrane in order to evaluate their augmentative potential. Methods Thirty-two critical size horizontal defects were prepared in the mandible of 4 adult foxhound dogs (8 per dog, 4 on each side). After 3 months of healing, the defects were laterally augmented in a split-mouth-design with either human (HXB) or bovine solvent-preserved bone blocks (BXB). Afterwards, defects were randomly covered with a bovine collagenous membrane (HXB + M, BXB + M). After a healing interval of 6 months, percentages of new bone formation, resorbed bone matrix, and fibrous enclosed residual bone substitute material were compared. Results Results showed little new bone formation of up to 3.7 % in human bone blocks (HXB 3.7 % ± 10.2, HXB + M 0.3 %± 0.4, BXB, 0.1 % ± 0.8, BXB + M 2.6 % ± 3.2, p = > 0.05). Percentages of fibrous encapsulation were higher in human bone blocks than in bovine bone blocks (HXB 71.2 % ± 8.6, HXB + M 73.71 % ± 10.6, BXB, 60.5 % ± 27.4, BXB + M 52.5 % ± 28.4, p = > 0.05). Resorption rates differed from 44.8 % in bovine bone blocks covered with a membrane to 17.4 % in human bone blocks (HXB 17.4 % ± 7.4, HXB + M 25.9 % ± 10.7, BXB, 38.4 % ± 27.2, BXB + M 44.8 % ± 29.6, p = > 0.05). The use of additional membranes did not significantly affect results. Conclusions Within its limitations, results of this study suggest that solvent-preserved xenogenic human and bovine bone blocks are not suitable for lateral bone augmentation in dogs. Furthermore, defect coverage with a membrane does not positively affect the outcome.

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