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Osteoarthritis, Knee clinical trials

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NCT ID: NCT05470608 Active, not recruiting - Clinical trials for Osteoarthritis, Knee Pain

Phase II Study to Assess Safety and Efficacy of SL-1002 for Osteoarthritic Knee Pain

COMPASS
Start date: June 13, 2022
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, double-blind, placebo-controlled, single ascending dose escalation study to assess the safety and efficacy of single treatment exposure of an injectable formulation of SL-1002 for the treatment of knee pain associated with osteoarthritis. Phase A of the study will enroll 3 cohorts of 8 patients per cohort, for a total of 24 patients. Patients will be randomized to receive either SL-1002 or placebo in a 3:1 ratio within each given cohort. Phase B of the study will enroll a minimum of 92 up to a maximum of 108 patients. Patients will be randomized to receive either SL-1002 or placebo in a 3:1 ratio at the recommended dose determined from Phase A. The study period will be up to 168 days inclusive of a screening period of up to 28 days.

NCT ID: NCT05469776 Active, not recruiting - Knee Osteoarthritis Clinical Trials

Bicruciate-retaining (2C) Total Knee Arthroplasty (TKA) Versus Posterior-stabilized (PS) Total Knee Arthroplasty (TKA)

Start date: November 1, 2011
Phase: N/A
Study type: Interventional

Total knee arthroplasty (TKA) with the sacrifice of the anterior cruciate ligament is the standard treatment for severe knee osteoarthritis. A number of studies on the kinematics of the prosthetic knee tend to show that implants that preserve the cruciate ligaments best reproduce the kinematics of the healthy knee. The goal is to compare the clinical and radiological results in patients undergoing total knee replacement surgery according to the type of prosthesis used. It is anticipated that the bicruciate-retaining prosthesis will result in better function of the operated knee than the posterior-stabilized prosthesis. Method: - Randomized controlled trial - Monocentric - Randomization will be done using sealed envelopes

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.

NCT ID: NCT05462990 Active, not recruiting - Clinical trials for Osteoarthritis, Knee

A Proof-of-concept Study to Examine QUC398 in Participants With Knee OA

Start date: November 9, 2022
Phase: Phase 2
Study type: Interventional

The purpose of the study is to find out if the investigational treatment named QUC398 has beneficial effects on osteoarthritis knee pain and knee cartilage, and if it is safe and well tolerated.

NCT ID: NCT05461638 Withdrawn - Knee Osteoarthritis Clinical Trials

Kinematic Alignment vs Mechanical Alignment for Total Knee Arthroplasty

KA vs MA
Start date: January 5, 2020
Phase: N/A
Study type: Interventional

This is a prospective, randomized, single-blinded, multi-center trial comparing Kinematic Alignment vs Mechanical Alignment in TKA patients using patient reported outcomes, clinical and functional performance tests and radiographic analyses.

NCT ID: NCT05460871 Terminated - Clinical trials for Osteo Arthritis Knee

Pregabalin for Central Sensitization in TKA

Start date: February 21, 2023
Phase: Phase 4
Study type: Interventional

The study purpose is to determine if giving pregabalin before and after total knee arthroplasty (TKA) can improve pain and meaningful function after surgery in patients that have central sensitization (CS). Participants will be identified who are indicated for TKA. Interested patients will complete a standard Knee Injury and Osteoarthritis Outcomes Score (KOOS), asked their pain score (on a scale of 0 to 10), and complete the Central Sensitization Inventory (CSI). If they meet inclusion criteria and agree to participate, they will complete the informed consent before being randomized 1:1 to usual care (control group) or pregabalin (study group). The study group participants will take pregabalin starting 7 days prior to surgery. They will also be scheduled to have a pre-operative physical therapy (PT) appointment which will include tests and measures standard to PT. Tests will include a Timed Up and Go Test (TUG), a Sit to Stand 5 Times Repeat Test (5TSTS) and Patient Specific Functional Scale (SFS) measures. On the day of surgery participants will be asked about any adverse effects of study medication and determine need to withdraw from study. The post-operative plan will be reviewed, including dose of study medication. For the pregabalin group the doses will be doubled for 7 days, then reduced for 7 days, then off. All participants will be given standard peri-operative pain management for TKA . All participants will complete standard of practice physical therapy. After surgery (usually within 7 days) a physical therapist will perform standard post-operative evaluation and treatment for all participants. This includes a re-evaluation of the same pre-operative functional tests of TUG, 5TSTS and PSFS outcome measures. The study pharmacist will also call the patient to determine if there are any medication-related adverse effects and how much opioid medication the patient is taking at that time (morphine milligram equivalents- MME/day on average). At the 6 week post-operative visit all participants will again complete the KOOS survey, report a pain score, complete the CSI survey and determine MME based on patient report of quantity of opioid medication used. A physical therapist will complete the functional assessment of the TUG, 5TSTS and PSFS outcome measures.

NCT ID: NCT05459584 Completed - Clinical trials for Osteoarthritis, Knee

Robotic Assisted Rehabilitation for Balance and Gait in Orthopedic Patients.

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

Osteoarthritis is a chronic, degenerative disease affecting the joints. It is characterized by the presence of bone tissue that goes to make up for the loss of articular cartilage, causing pain and limitation of movement. Osteoarthritis is a direct consequence of aging: it affects almost all 70-year-olds, peaking between 75 and 79 years. The presence of osteoarthritic processes at the hip and knee joints can result in pain, difficulty maintaining standing for a long time, and difficulty walking with loss of balance, increasing the risk of accidental falls to the ground. Falls are a frequent cause of mortality and morbidity and, often, limit autonomy leading to premature entry into assisted living facilities. In Italy, in 2002 it was estimated that 28.6% of people over 65 years fall within a year: of these, 43% fall more than once and 60% of falls occur at home. Such falls can often result in fractures leading to the need for hospitalization with significant impact on both motor and cognitive function. Balance and gait rehabilitation are of primary importance for the recovery of a person's autonomy and independence, especially in older individuals who have undergone osteosynthesis or prosthesis surgery of the lower limbs. Technological and robotic rehabilitation allows for greater intensity, objectivity, and standardization in treatment protocols, as well as in outcome measurement. In this context, patient motivation is fuelled and maintained by both the sensory stimuli that support technological treatment and the challenge of achieving ever better results, objective feedback from instrumental assessments. Osteoarthritic patients who have undergone osteosynthesis or lower extremity prosthetic surgery require special attention, especially with the goal of preventing further accidents and reducing the patient's risk of falling. Given these considerations, it is believed that conventional physical therapy combined with technological balance treatment may be more effective on rehabilitation outcome than conventional therapy alone.

NCT ID: NCT05456711 Recruiting - Knee Osteoarthritis Clinical Trials

Femoral Cartilage Thickness in Knee Osteoarthritis

Start date: May 15, 2022
Phase:
Study type: Observational [Patient Registry]

The aim of the study to investigate the relationship between femoral cartilage thickness in Ultrasonographic evaluation and inflammatory parameters, pain severity and functionality in participants with Knee Osteoarthritis

NCT ID: NCT05455177 Completed - Clinical trials for Osteoarthritis, Knee and Hip

Change in Patient Reported Outcomes and Wish for Joint Surgery

Start date: June 1, 2018
Phase:
Study type: Observational

Aim To investigate associations between within-person change in patient reported outcomes (PROMs) and wish for joint surgery during up to 12-month participation in a digital first-line intervention for knee and hip osteoarthritis (OA) comprising exercise and education. Methods Retrospective observational registry data. All participants enrolling between June 1st 2018 and September 30th 2021 with follow-up data and with a change in their wish for surgery (dichotomous, becoming wishing or unwishing) were included. Analysed PROMS comprised pain (numeric rating scale (NRS), 0-10), 5 level EuroQol - 5-dimension (EQ5D-5L, 0.243-0.976), overall health (NRS, 0-10), activity impairment (NRS, 0-10), walking difficulties (yes/no), fear of movement (yes/no), function and quality of life subscales of Knee/Hip injury and Osteoarthritis Outcome Score 12 Items (KOOS-12/HOOS-12, both 0-100). To capture effects of changes in PROMs over time on probability of wish for surgery, the investigators used fixed effect (conditional) logistic regressions.

NCT ID: NCT05454566 Not yet recruiting - Clinical trials for Osteoarthritis, Knee

A Study Evaluating the Safety, Tolerability, and Activity of ICM-203 in Subjects With Knee Osteoarthritis.

Start date: November 15, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the safety, tolerability, and activity of ICM-203, a recombinant adeno-associated viral (AAV) vector that expresses a therapeutic gene that promotes cartilage formation, reduces joint inflammation and pain, as well as improves joint physical function, by injecting escalating doses of ICM-203 into the knee of subjects with mild to moderate knee osteoarthritis (OA). Approximately 6 to 18 subjects will be enrolled into 3 successive dose-escalating groups in a 3+3 study design, whereby 3 study subjects in each group will be dosed sequentially with ICM-203 and 3 additional subjects will be dosed at the same dose level if a dose limiting toxicity (DLT) occurs in any of the first 3 subjects.