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Osteoarthritis clinical trials

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NCT ID: NCT06122727 Recruiting - Knee Osteoarthritis Clinical Trials

Comparison of Custom and Standard Total Knee Replacements

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

Total knee arthroplasty (TKA) is the most common surgery in North America and the second most common in Europe. One of the most critical issues for stability and durability of the interventional is the prosthesis-bone geometric fit, where a required a perfect match; the recent availability of custom 3D implants can overcome this problem. In order to further improve a TKA surgery, it is in fact, it is possible today to completely customize the procedure for each individual patient, with cost and time now accessible. This intervention can be performed with the use of instrumentation specific to the patient (so-called resin 'cutting templates' referred to as PSI, "Patient Specific Instrumentation") to make cuts accurate bone cuts in accordance with a specific 3D preoperative plan . Also the design and fabrication in of the components prosthetic components themselves, in metal and polyethylene, is done by means of 3D printing. Based on the unique anatomy of each patient, the precise sagittal orientation and axial rotation of the components of the prosthesis customized for the surgeon, it is possible to plan and perform the surgery quickly and in accordance with the exact specifications of the individual patient. These procedures should also make it possible to greatly reduce the instrumentation and the sizes that need to be available in the operating room, reducing time and costs associated with transportation and storage . The objective of this study is to compare primary TKAs performed with a customized procedure (prostheses customized for each patient based on his or her reconstructed knee morphology by tomographic scans, and implanted via cutting guides customized for the patient) with standard primary TKAs, considering: the objective radiological results, the subjective results of the patients and the costs of both procedures.

NCT ID: NCT06122116 Recruiting - Knee Osteoarthritis Clinical Trials

Investigating Orthobiologics After PRP and Photobiomodulation for Knee Osteoarthritis

Start date: October 13, 2023
Phase: N/A
Study type: Interventional

This research assesses the effects that Photobiomodulation Therapy (PBMT) has on Intra-articular administered Plasma-Rich Platelet (PRP) injections for Knee Osteoarthritis (KOA) treatment through evaluations of synovial and serum inflammatory and reparative biomarkers. A comparison of Physical Therapy (PT) vs PT + PRP vs PT + PBMT vs PT + PRP + PBMT for KOA treatment is made. The relationship between self-reported pain and functionality and treatment mechanisms is analyzed along with an analysis of the intersectionality between participant self-reported pain and functionality and medicine markers across treatment groups. These aims seek to inform current treatment practices in treating KOA and returning Active-Duty Service Members to duty readiness.

NCT ID: NCT06121882 Recruiting - Knee Osteoarthritis Clinical Trials

Microfragmented Adipose Tissue Compared to Saline Injection for the Treatment of Knee Osteoarthritis

ARISE2
Start date: March 15, 2024
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to examine the effect of a single autologous, intra-articular injection of MFat versus saline injection for the treatment of pain and function associated with K/L grade 2/3 knee Osteoarthritis. Participants will receive an injection of MFat or saline.

NCT ID: NCT06120920 Recruiting - Knee Osteoarthritis Clinical Trials

Comparison of Hip Strengthening Exercises and Core Stability Exercises in Patients With Knee Osteoarthritis

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

Knee Osteoarthritis is a chronic degenerative joint disease with complex etiology that results in loss of normal joint function due to damage to the articular cartilage. It is characterized by pain, swelling, inflammation and narrowing in articular cartilage. Hip muscle weakness has been observed in persons with knee OA and poor core stability may be one of the other contributing factors that lead to knee OA development as well as its progression. Core stabilization and muscular synergism of the trunk and hip work is an effective way to improve lower limb strength balance and prevent injury. So the lumbopelvic stability is vital to support loads on the knee joint.

NCT ID: NCT06118892 Recruiting - Clinical trials for Osteo Arthritis Knee

MISHA® Post-Market Clinical Study

Start date: November 3, 2023
Phase: N/A
Study type: Interventional

Prospective evaluation of the safety and effectiveness of the MISHA Knee System. The study will collect data on the procedural and long-term adverse events, WOMAC pain and function scores, KSS satisfaction, subsequent surgical interventions, BMI levels, range of motion, UCLA activity level of the subjects, and perform radiographic/x-ray evaluations at clinical visits through 5 years post-procedure. The primary analysis of this study is freedom from device- and procedure-related SSIs at five (5) years post-implantation. This study will also assess device performance in subjects with intact and retained devices and subjects with devices removed prior to study termination and freedom from conversion to arthroplasty through 5 years. Study subjects will be followed over a five-year post-implant period.

NCT ID: NCT06113783 Recruiting - Knee Osteoarthritis Clinical Trials

Assessment of Efficacy of a Single Intra-articular Injection of HYALUBRIX 60 in Knee Osteoarthritis

Start date: June 16, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effect of one single intra-articular (IA) injection of HYALUBRIX 60® plus physical exercise program (PEP) in terms of pain reduction, compared to PEP alone, in patients with knee osteoarthritis (OA).

NCT ID: NCT06113549 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Grip on Knee Osteoarthritis; DIstraction Versus Arthroplasty

GODIVA
Start date: December 2023
Phase: N/A
Study type: Interventional

The goal of this pragmatic, open, (1:1) randomized, multi-centre, non-inferiority trial is to to determine whether knee-joint distraction (KD) is non-inferior on patient reported effectiveness as compared to a knee-prosthesis (KP; i.e. usual care) for relatively young patients with end-stage knee Osteoarthritis (OA). The main question[s] it aims to answer are: - Is KD non-inferior to KP regarding pain, function and stiffness (as indicated by the total score on the total Western Ontario and McMaster Universities Osteoarthritis Index' (WOMAC), with a non-inferiority limit of 15 points) at 2 years? - Is KD non-inferior to KP regarding Quality of Life (36-Item Short Form Health Survey, (SF36), Physical- and Mental- Component Summary (PCS/MCS), with a non-inferiority limit of 10 points) at 2 years? - Does KD lead to regeneration of tissue (increase in minimum joint-space-width > 0.05mm on x-ray) over 2 years? Participants will be allocated to undergo either a knee joint distraction or prosthesis (total- or unicompartmental KP according to orthopedic surgeon/patients discretion), and groups will be compared using will be compared between groups using (multivariable) random effects (mixed) modelling to account for the nested and longitudinal structure of the data over the 24 months follow-up. The stratification factors for randomization, center (using a random intercept) and gender, as well as a limited number of a priori defined prognostic factors (i.e. baseline WOMAC total score, age, BMI, severity of cartilage damage) will be accounted for in this analysis. The difference in mean total WOMAC score at 24 months between treatment groups will be estimated from this model with a 95% confidence interval (CI) and non-inferiority will be determined using the lower limit of this confidence interval.

NCT ID: NCT06113536 Recruiting - Knee Osteoarthritis Clinical Trials

Evaluation of Meniscal Extrusion by Dynamic Ultrasonography in Patients With Ostearthritis

Start date: March 23, 2021
Phase: N/A
Study type: Interventional

This is a diagnostic, open-label, single-center interventional study. The aim of the study is to evaluate the relationship between medial and lateral meniscus extrusion determined by dynamic ultrasound study and bone edema assessed by MRI study in patients with knee OA. As a secondary objective, the correlation of the above parameters with the patient's symptomatology assessed by subject clinical questionnaires will be evaluated.

NCT ID: NCT06111690 Recruiting - Knee Osteoarthritis Clinical Trials

Blood Flow Restriction Training in Individuals Awaiting Total Knee Replacement

Start date: September 23, 2022
Phase: N/A
Study type: Interventional

The aim is to demonstrate that preoperative exercises (prehabilitation) using blood-flow restriction training (BFRT) is safe, well tolerated, improves muscle function, decreases functional limitation, and increases physical activity in older adults awaiting total knee replacement (TKR).

NCT ID: NCT06110104 Completed - Knee Osteoarthritis Clinical Trials

Effect of Retrowalking Program Versus Whole Body Vibration in Patients With Chronic Knee Osteoarthritis

Start date: September 11, 2023
Phase: N/A
Study type: Interventional

Osteoarthritis is one of the most common degenerative joint disease that affects approximately more than 300 million people worldwide