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Showing 1-11 of 11 trials
NCT07417436
The aim of our study is to evaluate the effects of graded motor imagery training applied in addition to a structured exercise program in individuals with foot and/or ankle osteoarthritis. The study population will consist of twenty-four individuals diagnosed with foot/ankle osteoarthritis who applied to the Orthopedics and Traumatology Department of Alanya Alaaddin Keykubat University Education and Research Hospital. Individuals who volunteer to participate in the study will be invited to participate through face-to-face interviews. The inclusion and exclusion criteria are as follows: Inclusion criteria: * Being 18 years of age or older * Having a diagnosis of foot/ankle osteoarthritis confirmed by a specialist physician through clinical and/or radiological examination * Experiencing pain in the ankle joint most days for at least three months * Agreeing to participate in randomly assigned treatment and follow-up measurements * Having a sufficient level of Turkish language comprehension * Having a Standardized Mini Mental Test score of at least 24 points Exclusion criteria: * Previous arthrodesis or joint replacement surgery on the affected ankle * Physical therapy for ankle osteoarthritis within the last three months * Vision or hearing problems that would affect compliance with treatment. * Presence of a neuromuscular disease * History of intra-articular ankle injections within the last 3 months * Initiation of a new disease-specific pharmacological treatment during the study period During the study period, participants will receive one of the physical therapy programs. One group will only participate in the structured exercise program, while the other group will receive graded motor imagery training in addition to the exercise program.Both treatment groups will receive a total of 12 treatment sessions over 6 weeks. The results of this study may help improve physiotherapy programs for individuals with similar health conditions.
NCT04405297
This is a prospective, multi-location safety and effectiveness study, and data registry of autologous adult ADRCs generated by the Transpose® RT System in subjects with OA in the shoulder, wrist, knee, hip, or ankle.
NCT04883892
The aim of the study is to compare the efficacy of the infiltrative therapy of BMAC vs HA up to 24 months in the treatment of the ankle osteoarthritis. The efficacy will be assessed through clinical, objective and subjective evaluations. After 12 months patients in the control group can decide to cross-over in the treatment group.
NCT03524729
Ankle osteoarthritis (OA) is a painful, progressive condition that can severely limit physical activity and reduce quality of life. Rocker bottom (RB) shoes and ankle-foot orthoses (AFOs) are commonly used as non-surgical treatments for ankle OA. RB shoes have a curved sole in the toe to heel direction that may alleviate joint pain by reducing ankle range of motion (ROM). Similarly, AFOs may reduce joint motion by securing the foot and ankle within the ankle-foot orthosis (AFO) frame. This study aims to determine the ability of RB shoes and AFOs to improve mobility, by relieving pain and reducing joint ROM.
NCT06514196
The H3 TAR device received U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) on June 4, 2019, and as a condition of that approval, this study is being conducted to provide long-term safety and effectiveness of the H3 TAR System among patients included in the Primary Safety and Effectiveness (PSE) Cohort (P1600361). This will be a Prospective, single-center, single arm study.
NCT06404801
I want to design Stance control orthotic knee joint for improvement of KAFO users which is not available in Pakistan imported stance control orthotic knee joints are very expensive patients can't afford. The aim of my study to develop low cost stance control knee joint and ensure its availablity for KAFO users.
NCT06028763
This study aims to evaluate the effectiveness of heparin-conjugated gel for treating ankle joint cartilage lesions compared to the conventional microfracture method. It involves 40 participants aged 18 to 65 with localized cartilage defects (Outerbridge II-IV) in the ankle's talus bone. Participants will be divided into two groups: the main group and the control group. The main group will undergo a two-stage process. Initially, adipose tissue will be collected via lipoaspiration from osteoarthritis patients. This tissue will be used to isolate mesenchymal stem cells (MSCs) and extract growth factors, resulting in a biocomposite hydrogel. In the second stage, arthroscopy will be performed to apply the hydrogel for cartilage treatment. The control group will undergo standard microfracture surgery, a known cartilage repair method. The study's main objective is to compare heparin-conjugated gel treatment to microfracture in terms of cartilage repair and patient outcomes. A 12-month follow-up will assess short-term and potential mid-term effects. Data will be analyzed using Microsoft Excel and Statistica 13.0 for descriptive and comprehensive statistical analysis. Quantitative indicators will be assessed using appropriate tests (Mann-Whitney, Wilcoxon T, χ2) to determine significant differences between groups. The study addresses key questions: Does heparin-conjugated gel offer better cartilage repair, functional improvement, and pain reduction than microfracture? Does the hydrogel approach better preserve joint integrity and slow degeneration? Are there complications with either method? This study combines cellular and surgical components to explore innovative cartilage lesion treatments. Comparing with microfracture and using a thorough follow-up, it aims to enhance cartilage repair techniques and patient outcomes.
NCT03711747
With IRB approval, a prospective single-cohort clinical trial will be performed to assess safety and efficacy of total biologic arthroplasty of the ankle. With informed consent, patients (n=10) who require tibio-talar arthroplasty based on physical examination and diagnostic imaging will be enrolled. Primary criteria for inclusion will be Grade IV changes in the articular cartilage of the tibial plafond and/or talar dome as determined by physical examination, diagnostic imaging and/or arthroscopy by the attending surgeon. Exclusion criteria include acute injury to any other part of the affected lower extremity or inability to comply with the protocol. After enrollment, patients will undergo standard ankle radiography and complete assessments (described below). Size-matched (standard clinical methodology) MOPSTM allografts (Musculoskeletal Transplant Foundation, Edison, NJ) from the same donor will be obtained to treat the entire tibiotalar joint. The affected joint will be treated with OCA transplants using our current technique and instrumentation. Osteochondral grafts including MOPSTM OCAs are regulated under U.S. Food and Drug Administration (FDA) section 361 of the Public Health Service Act and 21 Code of Federal Regulation 1271 that defines human cells, tissues or cellular or tissue based products (HCT/P). Patients will follow a managed post-operative rehabilitation protocol that is standard for those that have had an osteochondral allograft to their ankle. Range of motion and patient-reported outcome measures (PROMs) including VAS pain score, AOFAS, and PROMIS Mobility as well as complete radiographs (XR) of the affected ankle will be obtained prior to surgery and at 6 weeks, 3 months, 6 months, and 12 months after surgery to evaluate healing, function and evidence for arthrosis. MRIs for cartilage composition (12 months after surgery, and serum and urine biomarkers for treatment monitoring (preop, 6 and 12 months after surgery) will be performed. We will document all adverse events and complications, including joint or incision infection, graft failure, hardware failure, and arthrofibrosis. Patients with a VAS pain score \>5 beyond 3 months postoperatively or clinical or diagnostic imaging evidence for nonunion or graft collapse will undergo MRI of the ankle to determine the appropriate clinical course of action. OCA survival will be determined based on maintenance of acceptable levels of pain (\<2 VAS) and function and/or need for revision surgery or total ankle arthroplasty, fusion, or amputation.
NCT01504438
This is a randomized study to prospectively compare and evaluate the functional outcome and patient satisfaction of total ankle replacements for tibio-talar osteoarthritis using either the STAR or Salto-Talaris prothesis.
NCT04022928
Platelet-rich plasma (PRP) has been reported to be an effective treatment for knee osteoarthritis (OA). The application in ankle OA has rarely been investigated. The aim was to evaluate the efficacy and safety of a single intraarticular injection of PRP for the treatment of patients with ankle OA.
NCT01760577
The purpose of this study is to compare the effects of intraarticular Botulinum Toxin A versus intraarticular hyaluronate plus rehabilitation exercise in patients with ankle osteoarthritis.