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Osteoarthritis clinical trials

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NCT ID: NCT05992038 Recruiting - Clinical trials for Osteo Arthritis Knee

Use of a Putty as Gap Filler in Open-wedge Osteotomy

AXOS
Start date: September 20, 2023
Phase: N/A
Study type: Interventional

Rationale: Realignment osteotomies around the knee are a proven surgical treatment for unicompartmental knee osteoarthritis and a malalignment. Osteotomies can be very painful in the early postoperative phase. This is probably due to a combination of bony cut (bone pain) and postoperative hematoma (bleeding and leakage of the bone marrow) in the surrounding soft tissue. The AttraX® Putty can be used as a gap filler in open wedge osteotomies to potentially reduce postoperative pain by reducing the bleeding from the bone gap. Objective: The main aim of this study is to determine whether early postoperative pain is decreased when the osteotomy gap is filled with AttraX® Putty, compared to conventional open wedge osteotomy without filling the gap. The secondary aims are faster accelerated rehabilitation/regaining function, reduction of local blood loss, accelerated bone union, comparable surgical accuracy, and the occurrence of (serious) adverse events. Study design: Single-blinded, prospective, randomized controlled trial. Study population: Adult patients qualifying for open-wedge tibial, open-wedge femur or double level osteotomy. Intervention: According to a randomization scheme, the osteotomy gap will be filled with either the synthetic ceramic material AttraX® Putty or without a gap filler (conventional method). Main study parameters/endpoints: The main study endpoint is the Numeric Rating Scale (NRS) pain during the first week postoperative. The secondary study endpoints are faster rehabilitation/regaining function, reduction of local blood loss, accelerated bone union, comparable surgical accuracy, and (serious) adverse events. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients may have the advantage of experiencing less pain postoperatively if they are treated with the AttraX® Putty, which can contribute to a faster rehabilitation. Risks to the AttraX® Putty group may include an allergic reaction, failure to promote bone fusion and excessive bone growth. However, the preclinical studies and clinical studies show that the use of AttraX® Putty is safe for use in humans.

NCT ID: NCT05988307 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Effect of Percussion Massage Gun on Hamstrings Flexibility.

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

The purpose of this study would be to investigate: - The effect of using percussion massage gun on Hamstring flexibility in patients with knee osteoarthritis. - The effect of using percussion massage gun on pain in patients with knee osteoarthritis. - The effect of using percussion massage gun on ROM in patients with knee osteoarthritis. - The effect of using percussion massage gun on knee function in patients with knee osteoarthritis.

NCT ID: NCT05986617 Enrolling by invitation - Obesity Clinical Trials

Wearable Bioimpedance Analyzer for Tracking Body Composition Changes

Start date: July 14, 2023
Phase: N/A
Study type: Interventional

Obesity, namely at body mass index (BMI) levels exceeding 40kg/m2 (class III obesity), is a risk factor for many diseases including osteoarthritis (OA). In arthroplasty, patients in this population frequently present for and are turned away from surgical intervention. Subsequently, efforts are made to decrease BMI through simple weight loss, yet these have been suggested as ineffective and counterproductive. Furthermore, simple weight loss may include muscle mass loss, which is an additional risk factor for surgery. At the University of Iowa Hospitals and Clinics Orthopedics Department, efforts have been made to encourage muscle mass gain and body fat loss over simple weight loss where progress has been tracked through stationary, multi-frequency bioimpedance analysis (BIA). BIA is a readily available technology offered to industry and consumers, and BIA has recently been incorporated into wearable devices. In the UIHC Orthopedics department, a novel clinic aimed at holistically serving the osteoarthritic-class III obese population for controlled and monitored weight loss through BIA. This study, a randomized controlled trial, aims to recruit adult patients with class III obesity presenting to the arthroplasty-obesity clinic. While all patients will receive individual body composition coaching to increase muscle mass and decrease body fat mass, they will be randomized to one of two cohorts: the study group will receive a wearable BIA wristband (InBody BAND 2) and instruction on its use in addition to the standard coaching, and the control group will only receive the standard coaching. This study aims to identify if the use of a wearable BIA wristband aids in the desired body composition changes. In addition, this study aims to quantify the body composition changes exhibited by each cohort. Finally, this study aims to track surgical outcomes for those patients that are indicated for total joint arthroplasty.

NCT ID: NCT05986513 Not yet recruiting - Chronic Pain Clinical Trials

Brain MRI for Knee OA

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

It has been estimated that 300 million people worldwide have osteoarthritis (OA), and this has increased by 97% over the past 25 years. OA is degenerative joint disease that has joint cartilage break down and causes the surrounding bone to change and rub. The pain and loss of mobility experienced by people with knee OA can seriously reduce quality of life, while pain management causes significant healthcare spending. Unfortunately, the pain associated with OA is complex and difficult to treat other than to have a total knee replacement surgery to replace the damaged bone and surrounding tissues with artificial ones. Our research study plans to use advanced magnetic resonance imaging techniques and novel analysis methods to determine if specific parts of the brain are responsible for difficult to describe and diagnose aspects of chronic pain. This study will help us better understand the effects of chronic pain in the brain and the results will help guide future research into new therapeutic options that would focus on relieving the brain dysfunction caused by chronic pain.

NCT ID: NCT05985785 Recruiting - Clinical trials for Osteoarthritis of the Knee

Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection

BMAC
Start date: July 19, 2022
Phase: N/A
Study type: Interventional

Prospective single-masked (study participant will be masked), randomized controlled trial to examine the influence of BMAC on patient-reported outcomes (PROs) in patients with primary knee osteoarthritis.

NCT ID: NCT05981534 Recruiting - Knee Osteoarthritis Clinical Trials

The Effectiveness of Vitamin D Supplementation in Patients With End-stage Knee Osteoarthritis

Start date: March 17, 2024
Phase: N/A
Study type: Interventional

Osteoarthritis (OA) knee is one of the commonest chronic degenerative conditions. It causes disability in elderlies due to pain and stiffness. The prevalence of radiologic knee osteoarthritis increases in proportion to age, reaching an astounding 64.1% for patients who are over 60 years of age. In 2021, there were over 26,000 patients on the Hospital Authority (HA) waiting list for knee total knee replacement (TKR) and with only 4300 TKRs performed, the nominal waiting time for TKR was almost 89 months. Low vitamin D can adversely affect cartilage thickness and study suggested that low serum vitamin D is associated with increased radiographic knee OA progression. A systematic review concluded that vitamin D supplements can improve pain and function in patients with knee OA. Vitamin D has long been recognized for its effect on musculoskeletal health and increasing attention has been focused for its effect on muscle function. Vitamin D have a direct effect on muscle hypertrophy by acting on specific vitamin D receptors (VDRs) on myocytes, and sufficient levels of vitamin D in patients have been found to correlate with an increase in the size, number, and strength of muscle fibres. Vitamin D also seems to exert beneficial effects by its interplay with myokines such as myostatin and irisin. One study also showed that muscle nuclear VDR was increased by 30% and augmented muscle fibre size by 10% in elderly females (mean age of 78 years) taking vitamin D orally at a rate of 100 µg/day (4000 IU/day) for 4 months. This will be a double-blinded RCT investigating the effect of vitamin D supplements or knee muscle strength, physical function, pain symptoms and, sarcopenia status. The study will be a follow-up study with assessment at baseline, 3- ,6-and 12-months post vitamin D intervention.

NCT ID: NCT05980793 Recruiting - Surgery Clinical Trials

Denervation for Osteoarthritis in the PIP-joint Efficacy Study (DOPS)

Start date: September 25, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the effects of a surgical and a non-surgical treatment method in patients with osteoarthritis in the proximal interphalangeal (PIP) joint. The main questions it aims to answer are: - Are the treatments effective? - Is the surgical treatment more effective than the non-surgical treatment? Participants will receive surgical treatment (PIP joint denervation) or non surgical treatment (patient education plus exercise). Researchers will compare the non-surgical and surgical groups to see if pain, patient-reported function, quality of life, movement and grip strength differs between the groups.

NCT ID: NCT05980338 Recruiting - Knee Osteoarthritis Clinical Trials

Knee Genicular Nerve Ablation by Thermal Radiofrequency vs Thermal Radiofrequency Plus Alcohol Neurolysis

Start date: June 17, 2023
Phase: N/A
Study type: Interventional

the aim of our study is to compare effectiveness (satisfaction) and duration of pain relief between patients receiving the conventional thermal radiofrequency on the genicular nerves alone vs patients who will receive the conventional method plus alcohol neurolysis of the targeted nerves.

NCT ID: NCT05980234 Enrolling by invitation - Osteoarthritis Clinical Trials

MDR - Longevity IT Oblique and Offset Liners

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

The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Longevity IT Oblique and Offset liners when used for primary or revision total hip arthroplasty (implants and instrumentation) at a minimum of 10-year follow-up.

NCT ID: NCT05978180 Recruiting - Knee Osteoarthritis Clinical Trials

Safety of Use and Efficacy of Pandora for Patients Suffering From Gonarthrosis (PANDORA2)

PANDORA2
Start date: October 18, 2023
Phase: N/A
Study type: Interventional

The knee osteoarthritis is a frequent degenerative condition that mainly affects subjects over 60, population often weakened by numerous comorbidities and concomitant treatments, justifying the development of new therapies. The viscosupplementation is a symptomatic treatment for knee osteoarthritis ; the objective of this intra-articular injection of hyaluronic acid is to reduce knee pain and improve mobility. In practice, there are two protocols to administer viscosupplementation : in a single injection or in three injections performed weekly. The present clinical investigation has the objective to evaluate the safety and efficacy of use of Pandora, a hyaluronic acid associated with tranexamic acid, in a single injection (HO-1) or in three injections performed weekly (HS-3), compared to a referred and commercialized medical device.