New Adjustable Unloader Knee Brace and Its Effectiveness

2017 ◽  
Vol 12 (1) ◽  
Author(s):  
Gajendra Hangalur ◽  
Ryan Bakker ◽  
Sebastian Tomescu ◽  
Naveen Chandrashekar

Unloader knee braces are prescribed for patients with unicompartmental osteoarthritis of the knee. These braces aim to reduce pain in patients by applying a coronal moment to the knee to unload the symptomatic knee compartment. However, existing unloading mechanisms use straps that go directly behind the knee joint, to apply the needed moment. This can impinge on the popliteal artery and peroneal nerves thereby causing discomfort to the patient. Hence, these braces cannot be worn for prolonged periods of time. This research focused on developing a new knee brace to improve comfort while unloading the osteoarthritic knee. A new knee brace was developed that uses a four-point bending approach to unload the knee. In this brace, unloading can be adjusted, and the unloading mechanism is away from the joint. The new brace was tested on a cadaver specimen to quantify its capability to unload the knee compartment. The brace was also worn by a patient with osteoarthritis who subjectively compared it to his existing unloader brace. During cadaver testing, the new brace design could reduce the force exerted on the medial condyle by 25%. Radiographic images of the patient's knee confirmed that the brace unloaded the medial condyle successfully. The patient reported that the new brace reduced pain, was significantly comfortable to wear and could be used for a longer duration in comparison to his existing brace.

2020 ◽  
Vol 8 (7_suppl6) ◽  
pp. 2325967120S0045
Author(s):  
David Klein ◽  
David Bloom ◽  
Kirk Campbell ◽  
Guillem Gonzalez-Lomas ◽  
Michael Alaia ◽  
...  

Objectives: Osteoarthritis, a degenerative and debilitating joint disease, is one of the most prevalent diseases in the United States. Despite the significant burden osteoarthritis can place on an individual and society, nonoperative treatment options are still very limited. Little clinical data exists on the use of injectable macromolecules for the treatment of osteoarthritis of the knee. Alpha-2-macroglobulin (A2M), a naturally occurring macromolecule, inhibits the many endogenous and exogenous proteinases presenting in the pathogenesis of osteoarthritis. To date, no studies exist evaluating the effectiveness of A2M with other intra-articular injectables. The purpose of this study is to compare the clinical effectiveness of intra-articular injection of A2M against both platelet-rich plasma (PRP) and corticosteroids. Methods: This prospective randomized control trial was conducted at a single medical center. Seventy-five patients with symptomatic knee osteoarthritis with Kellgren-Lawrence grade 2 or 3 were randomized into one of three cohorts receiving intra-articular injection. One group was given PRP, one group was given A2M, and one group was given corticosteroids. All groups had blood drawn to simulate A2M preparation. Patient reported outcomes were collected prior to injection, 6 weeks and 12 weeks following injection. Several measures were used for clinical assessment including the visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee Injury and Osteoarthritis Outcome Score (KOOS), Lysholm, and Tegner scores. Results: Seventy-five patients with a mean age of 61.08 (± 8.48) were enrolled between June 2018 and February 2019. At six weeks, the A2M group had the greatest decrease in VAS (-1.60) and WOMAC (-10.9), however, the differences were not statistically significant. Between the injection and the twelve week visit, the A2M group had a statistically significant difference in WOMAC score compared with PRP (-18.43 vs -5.70, p <0.02). Overall, both corticosteroid (-1.57) and A2M (-1.70) had a similar improvement in VAS when compared with PRP (-0.61). These differences were also not statistically significant. Conclusions: Our study demonstrates Alpha 2 Macroglobulin shows similar effectiveness to corticosteroids in the treatment of knee osteoarthritis. Both A2M and corticosteroids appear to show marginally better effectiveness than PRP injection, however the differences are small and did not reach statistical significance in most outcome measures.


2021 ◽  
pp. 026921552199363
Author(s):  
Martin Schwarze ◽  
Leonie P Bartsch ◽  
Julia Block ◽  
Merkur Alimusaj ◽  
Ayham Jaber ◽  
...  

Objective: To compare biomechanical and clinical outcome of laterally wedged insoles (LWI) and an ankle-foot orthosis (AFO) in patients with medial knee osteoarthritis. Design: Single-centre, block-randomized, cross-over controlled trial. Setting: Outpatient clinic. Subjects: About 39 patients with symptomatic medial knee osteoarthritis. Interventions: Patients started with either LWI or AFO, determined randomly, and six weeks later changed to the alternative. Main measures: Change in the 1st maximum of external knee adduction moment (eKAM) was assessed with gait analysis. Additional outcomes were other kinetic and kinematic changes and the patient-reported outcomes EQ-5D-5L, Oxford Knee Score (OKS), American Knee Society Clinical Rating System (AKSS), Hannover Functional Ability Questionnaire – Osteoarthritis and knee pain. Results: Mean age (SD) of the study population was 58 (8) years, mean BMI 30 (5). Both aids significantly improved OKS (LWI P = 0.003, AFO P = 0.001), AKSS Knee Score (LWI P = 0.01, AFO P = 0.004) and EQ-5D-5L Index (LWI P = 0.001, AFO P = 0.002). AFO reduced the 1st maximum of eKAM by 18% ( P < 0.001). The LWI reduced both maxima by 6% ( P = 0.02, P = 0.03). Both AFO and LWI reduced the knee adduction angular impulse (KAAI) by 11% ( P < 0.001) and 5% ( P = 0.05) respectively. The eKAM (1st maximum) and KAAI reduction was significantly larger with AFO than with LWI ( P = 0.001, P = 0.004). Conclusions: AFO reduces medial knee load more than LWI. Nevertheless, no clinical superiority of either of the two aids could be shown.


2020 ◽  
Vol 14 (1) ◽  
pp. 135-139
Author(s):  
Wataru Kusano ◽  
Takatomo Mine ◽  
Koichiro Ihara ◽  
Hiroyuki Kawamura ◽  
Michio Shinohara ◽  
...  

Untreated leg length discrepancy can cause spontaneous osteonecrosis of the knee, which is associated with subchondral insufficiency fractures of the knee and progression or onset of osteoarthritis of the knee. Spontaneous osteonecrosis of the knee can be secondary to cartilage loss or additional subchondral changes. A 40-year-old female underwent opening-wedge high tibial osteotomy and osteochondral grafting for osteonecrosis of the femoral medial condyle and osteoarthritis of the knee caused by leg length discrepancy after a traffic accident. High tibial osteotomy and cartilage restoration are often considered for the treatment of knee osteonecrosis with cartilage damage in younger patients.


2019 ◽  
Vol 32 (11) ◽  
pp. 1143-1154 ◽  
Author(s):  
Jack Farr ◽  
Andreas H. Gomoll ◽  
Adam B. Yanke ◽  
Eric J. Strauss ◽  
Katie C. Mowry ◽  
...  

AbstractPlacental-derived tissues are a known source of anti-inflammatory and immune modulating factors. Published pilot data on amniotic suspension allograft (ASA) for the treatment of osteoarthritis (OA) demonstrated safety and trends for improved pain and function. A multicenter randomized controlled trial was designed to evaluate the efficacy of symptom modulation with ASA compared with saline and hyaluronic acid (HA) in subjects with knee OA. A total of 200 subjects were randomized 1:1:1 to ASA, HA, or saline, with subjects blinded to their allocation. Changes from baseline of patient-reported outcomes (PROs)—EQ-5D-5L, Knee Osteoarthritis Outcome Score (KOOS), visual analog scale (VAS), Tegner, and Single Assessment Numerical Evaluation (SANE)—were compared between groups. Patients reporting unacceptable pain at 3 months were considered treatment failures and withdrawn from the study. Statistical analysis was completed by comparing changes in PROs from baseline to 3 and 6 months for all groups. Comparison of demographics between treatment groups showed no significant differences between groups. Patients reporting unacceptable pain at 3 months in each group were ASA (13.2%), HA (68.8%), and saline (75%). Patients receiving ASA demonstrated significantly greater improvements from baseline for overall pain (VAS), KOOS pain, and KOOS-activities of daily living scores compared with those in the HA group (3 months) and both groups (6 months). ASA patients had significantly greater improvements in KOOS symptom scores compared with HA and saline at 3 and 6 months, respectively. OMERACT-OARSI responder rates for ASA, HA, and saline groups were 69.1, 39.1, and 42.6%, respectively (p = 0.0007). Subjects receiving ASA treatment showed greater improvements in PROs and fewer patients reported unacceptable pain compared with HA and saline. The evidence presented in this Level I Randomized Controlled Trial suggests that ASA injection is an effective treatment for the nonoperative management of symptomatic knee OA.


Author(s):  
Ebtesam Abdulla ◽  
Krishna Das ◽  
Joseph Ravindra ◽  
Tejal Shah ◽  
Sara George

AbstractSkull base osteomas (SBOs) are benign tumors that are frequently detected on radiographic images by coincidence. They are known for being slow-growing tumors and rarely symptomatic. The therapeutic approach for SBOs can differ substantially. Depending on the symptoms, size, and location of the tumor, this can range from serial observation to vigorous surgical extirpation. Clival osteoma is extremely rare. We report a case of clival osteoma, causing intractable trigeminal neuralgia due to the pressure effect on the trigeminal nerve at Meckel's cave. We also provide a review of pertinent literature. A 37-year-old woman presented with intractable trigeminal neuralgia. Cranial magnetic resonance imaging (MRI) demonstrated a large, lobulated, extra-axial lesion involving the right cerebellopontine angle and epicentering the clivus. Pathologically, the specimen was proven to be osteoma. The patient reported complete symptom resolution over a 4-year follow-up period. To the best of the authors' knowledge, this is the first clinical case of intractable trigeminal neuralgia due to clival osteoma.


2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Ashim Gupta ◽  
Nicola Maffulli ◽  
Hugo C. Rodriguez ◽  
R. Justin Mistovich ◽  
Kristin Delfino ◽  
...  

Abstract Background Musculoskeletal conditions are highly prevalent, and knee OA is most common. Current treatment modalities have limitations and either fail to solve the underlying pathophysiology or are highly invasive. To address these limitations, attention has focused on the use of biologics. The efficacy of these devices is attributed to presence of growth factors (GFs), cytokines (CKs), and extracellular vesicles (EVs). With this in mind, we formulated a novel cell-free stem cell-derived extract (CCM) from human progenitor endothelial stem cells (hPESCs). A preliminary study demonstrated the presence of essential components of regenerative medicine, namely GFs, CKs, and EVs, including exosomes, in CCM. The proposed study aims to evaluate the safety and efficacy of intraarticular injection of the novel cell-free stem cell-derived extract (CCM) for the treatment of knee OA. Methods and analysis This is a non-randomized, open-label, multi-center, prospective study in which the safety and efficacy of intraarticular CCM in patients suffering from grade II/III knee OA will be evaluated. Up to 20 patients with grade II/III OA who meet the inclusion and exclusion criteria will be consented and screened to recruit 12 patients to receive treatment. The study will be conducted at up to 2 sites within the USA, and the 12 participants will be followed for 24 months. The study participants will be monitored for adverse reactions and assessed using Numeric Pain Rating Scale (NPRS), Patient-Reported Outcomes Measurement Information System (PROMIS) Score, Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.), 36-ietm short form survey (SF-36), Single Assessment Numeric Evaluation (SANE), physical exams, plain radiography, and magnetic resonance imaging (MRI) with Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score for improvements in pain, function, satisfaction, and cartilage regeneration. Discussion This prospective study will provide valuable information into the safety and efficacy of intraarticular administration of cell-free stem cell-derived extract (CCM) in patients suffering with grade II/III knee OA. The outcomes from this initial study of novel CCM will lay the foundation for a larger randomized, placebo-controlled, multi-center clinical trial of intraarticular CCM for symptomatic knee OA. Trial registration Registered on July 21, 2021. ClinicalTrials.gov NCT04971798


2021 ◽  
Vol 3 (1) ◽  
pp. e19-e28
Author(s):  
Nathan Hogaboom ◽  
Ella D'Amico ◽  
Ken Mautner ◽  
Christopher Rogers ◽  
Gerard Malanga

BackgroundTo evaluate changes in pain, function, and quality of life after treatment with injected micro-fragmented adipose tissue (MFAT) for knee osteoarthritis in a large cohort of individuals treated at multiple centers. MethodsOne hundred ten individuals were recruited from three private outpatient clinics. Participants had to be diagnosed with symptomatic knee OA (defined by persistent knee pain associated with clinical symptoms of OA and/ or classic imaging findings) and who had not received prior knee surgery or treatment with platelet-rich plasma, cortisone, or hyaluronic acid within the previous 6 weeks. Data from 120 knees were included in the analysis. Outcome measures included Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales (pain, symptoms, activities of daily living [ADL], sports and recreation, quality of life [QOL]) and an 11-point Numerical Rating Scale (NRS) for average knee pain over the past week. Outcomes were collected at baseline and 3, 6, and 12 months. ResultsSignificant increases and decreases in KOOS subscale and NRS scores were observed, respectively, in the cohort as a whole (p< .05). Lower BMI was associated with more significant improvements in pain, sports/recreation, and ADL KOOS subscale scores (p< .05). Greater age was associated with more significant improvements in symptoms and QOL subscale scores (p< .05). ConclusionsA single injection of MFAT improved pain, function, and QOL outcome measures up to 12 months in this cohort for more than half of the participants. Greater BMI and lower age negatively influenced outcomes. It is not known whether improvements continue after this timeframe or why many participants reported little-to-no improvement.


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