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Osteoarthritis, Knee clinical trials

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NCT ID: NCT05590663 Not yet recruiting - Knee Osteoarthritis Clinical Trials

FAST and PSFS: Assessment and Validation of Two Functional Scales in Patients With Knee OA in Singapore

Start date: October 2022
Phase:
Study type: Observational [Patient Registry]

The new National One-Rehab framework mandates the use of the Patient-Specific Functional Scale (PSFS) as an outcome measure to track patients' rehabilitation progress. Anecdotally, we have encountered patients (especially elderly ≥ 65 years old) with difficulty understanding and completing such questionnaire accurately. We developed a pictorial functional scale (Functional Activity Scoring Tool, FAST) with reference to the successful application of the Wong-Baker FACES pain rating scale. Concurrently, we hope to validate PSFS and FAST against Knee injury and Osteoarthritis Outcome Score (KOOS) which is validated in Singapore population. This study aims to investigate the reliability and validity of the PSFS and FAST in patients with knee osteoarthritis. We hypothesize that both the PSFS and FAST can be used to measure difficulty in performing activities of daily living in patients with knee osteoarthritis in a reliable and valid manner. The FAST and PSFS questionnaires will be administered to patients in SingHealth Polyclinics with knee osteoarthritis to explore the psychometric and clinimetric properties. Eligibility criteria were: age 45 and above, proficient in English, diagnosed with knee osteoarthritis. Patients were excluded if they have underlying medical or trauma conditions (i.e., trauma, fracture, infection, inflammatory disease, tumor), history of knee surgery within the last 3 months, or clinically recognizable cognitive impairment. Eligible patients will be informed about the purpose of the study and the confidentiality and anonymity of the process. After giving written consent they will complete a questionnaire on demographic and clinical characteristics and the sets of outcome measures (FAST, KOOS, PSFS). Participants will then return at two-to-three weeks later to complete the sets of outcome measures again and GROC, and to state their preferred outcome measures. Statistical analysis will be conducted to evaluate the validity and reliability of PSFS and FAST against KOOS.

NCT ID: NCT05561010 Not yet recruiting - Chronic Pain Clinical Trials

Understanding Pain Mechanisms in Knee Osteoarthritis

UP-KNEE
Start date: October 2022
Phase: N/A
Study type: Interventional

UP-KNEE study is a feasibility, double-blind, placebo-controlled randomised parallel study in participants with radiographically defined knee OA, and with self-reported chronic knee pain.

NCT ID: NCT05559268 Not yet recruiting - Clinical trials for Osteoarthritis, Knee

Effects of Denosumab on Bone Microarchitecture After Total Knee Arthroplasty

Start date: October 1, 2022
Phase: Phase 4
Study type: Interventional

This study evaluates single dose of Denosumab in decreasing systemic and periprosthetic bone resorption after Total Knee Arthroplasty compared to placebo in 60 patients (30 placebo and 30 Denosumab) within 2 months after surgery. This study also evaluates the anti-RANKL effect of single dose of Denosumab in serum, skeletal muscle, synovium, fat, and cartilage.

NCT ID: NCT05517434 Not yet recruiting - Clinical trials for Osteoarthritis, Knee

Autologous BMA vs Saline and LAM + LP-PRP vs Saline Evaluations in Knee OA

ABLE-OA
Start date: June 2024
Phase: Phase 2/Phase 3
Study type: Interventional

ABLE OA is a Health Canada authorized (phase II/III) trial [Parent Control #: 263591]. A multi-center, prospective, double-blinded, randomized, placebo-controlled adaptive trial to evaluate the efficacy of two minimally manipulated autologous cellular preparations i) bone marrow aspirate (BMA) injection; and, ii) combined lipoaspirate micronized (LAM) and leukocyte poor (LP) platelet-rich plasma (PRP) injections for the treatment of knee osteoarthritis (OA). BMA, LAM from lipoaspirate (LA), and LP-PRP from whole blood will be prepared using the Cervos Marrow Cellution™ Bone Marrow Aspiration System, Cervos LIPO-PRO™ Adipose Transfer System, and Cervos KEYPRP Platelet Separator System, respectively. Patient-reported outcome measures will be collected using web- or paper-based questionnaires administered at baseline (pre-injection) as well as at 3, 6 and 12 months (post-injection). Blood, synovial fluid, and urine samples will be collected at baseline pre-injection and 6 months post-injection only.

NCT ID: NCT05514704 Not yet recruiting - Clinical trials for Osteoarthritis, Knee

Effects of Different Telerehabilitation Methods on Pain, Functional Limitation, Muscle Strength, Balance, and Quality of Life in Patients With Knee Osteoarthritis.

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

The aim of our study is; To compare the effectiveness of asynchronous and synchronous telerehabilitation programs on pain, functional limitation, muscle strength, balance and quality of life parameters in patients with knee osteoarthritis. 60 patients with knee osteoarthritis who applied to Marmara University Faculty of Health Sciences Physiotherapy and Rehabilitation Department will be included in our study. The treatment and evaluations to be made will be explained and their consent will be obtained with their signatures. Patients will be randomly assigned to the asynchronous telerehabilitation group (n= 30 patients) and the synchronous telerehabilitation group (n= 30 patients). In the asynchronous telerehabilitation group, the rehabilitation program will be carried out via a mobile application (Diabetex). The coordinator will forward the exercise programs prepared specifically for the patients to the relevant participants through the application. On the other hand, telerehabilitation in the synchronous group will be carried out via video conference (Zoom). Patients will be taken to video conference calls and will perform their exercises simultaneously under the guidance of the researcher. An exercise program including lower extremity strengthening and stretching exercises will be applied to all patients. In both groups, the exercise program will be applied 3 days a week for 8 weeks, 1 session per day and 45 minutes per session. All outcome parameters will be evaluated by a blinded assessor who has not seen patients before. Patients starting the rehabilitation program will be evaluated at the beginning of the study, at weeks 4, 8, and 16. The information of the patients participating in the study will be taken with the demographic data form. Pain in patients will be measured with the Visual Analog Scale, while the functionality of the patients will be evaluated with the WOMAC osteoarthritis index and the Lysholm Knee Scoring Scale. In addition, the affected quality of life of the patients will be evaluated with the Patient Generated Index and Short Form-12 scales. While the functional mobility of the patients was evaluated with the Timed Up and Go Test; functional capacities 2 Minute Walk Test, and lower extremity neuromuscular function levels 30 sec. It will be evaluated with Sit and Stand and 5 Sit and Stand performance tests. In addition, the Unilateral Posture Test, Limits of Stability Test, Sit and Stand Up Test will be performed using the NeuroCom Balance Master Posturography device for balance evaluation, and knee flexion and extension muscle strength and proprioception will be evaluated with the Isokinetic device.

NCT ID: NCT05512507 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Sanomechanics® Rehabilitative Technology

Start date: January 30, 2023
Phase:
Study type: Observational

Rehabilitative Sanomechanics Method (RSM) of exercise designed to restore normal subperiosteal transmission of in-joint pressures and normalizing contact pressures on cartilages, will reduce pain in the affected joints and improve locomotor function.

NCT ID: NCT05510648 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis

Start date: September 25, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the effects of high intensity laser therapy (HILT) on range of motion, pain, quality of life, muscle strength and femoral cartilage thickness in patients with knee osteoarthritis.

NCT ID: NCT05507619 Not yet recruiting - Clinical trials for Osteoarthritis, Knee

Heat and Acupuncture Randomised Controlled Trial to Manage Osteoarthritis of the Knee

HARMOKnee
Start date: August 17, 2022
Phase: N/A
Study type: Interventional

Knee osteoarthritis (KOA) is one of the largest and fast-growing causes of pain, impaired mobility, and poor quality of life in the elderly worldwide. Despite a significant increase in Traditional Chinese Medicine (TCM) utilisation, in particular acupuncture, as first or second-line treatment among local KOA patients, there exists a lack of high-quality evidence on its efficacy and local practice guidelines for TCM use in KOA tailored to our specific population demographic. HarmoKNEE trial aims to address these gaps by evaluating the short and medium-term clinical and cost-effectiveness of TCM acupuncture with far-infrared heat therapy in addition to standard care, compared to standard care alone. Through a robust process and economic evaluation, the investigators aim to inform evidence-based practice for KOA patients in Singapore to facilitate the large-scale implementation of a comprehensive and holistic model of care which harmonises elements from Western medicine and TCM. The investigators hypothesize that acupuncture with heat therapy as an adjunct to standard care is clinically more effective than standard care alone. This will be a multi-centre pragmatic, parallel-arm, single-blinded, effectiveness-implementation hybrid randomised control trial. KOA patients will be randomised to either the control arm (standard care only) or intervention arm (biweekly sessions of acupuncture with heat therapy over 6 weeks, in addition to standard care). A mixed-method approach through an embedded process evaluation will facilitate large scale implementation. An economic evaluation will be performed to evaluate financial sustainability

NCT ID: NCT05477745 Not yet recruiting - Knee Osteoarthritis Clinical Trials

The Correlation Between Femoral Component Implanting Flexion Angle and Posterior Condyle Offset in Cruciate Retaining Total Knee Arthroplasty

Start date: July 29, 2022
Phase:
Study type: Observational

The main aim and scope is making measurement and comparison about the femoral component posterior offset under different femoral component implanting flexion angle in cruciate retaining total knee arthroplasty. The results may identify the influence of the flexion component implanting flexion angle on the femoral component posterior offset.

NCT ID: NCT05467592 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Central Sensitization in Patients Seeking Outpatient Physical Therapy Services

Start date: July 18, 2022
Phase:
Study type: Observational

This is an observational study to examine presence of CS in patients with knee osteoarthritis (OA), chronic LBP (CLBP), and chronic neck pain (CNP) seeking outpatient physical therapy (PT) services. The study will also examine if outcomes differ between patients with CS and patients without CS symptoms with standard PT interventions.