West Orange, NJNCT05596591Now EnrollingIRB Ready

Bone Marrow Edema Clinical Trial in West Orange, NJ

Access cutting-edge bone marrow edema treatment through this clinical trial at a research site in West Orange. Study-provided care at no cost to qualified participants.

Sponsored by Kessler Foundation

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Expert Care in West Orange

Access bone marrow edema specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related bone marrow edema treatment provided free

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Check if you qualify for this bone marrow edema clinical trial in West Orange, NJ

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to West Orange

    Convenient for NJ residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit West Orange site if eligible
  4. 4Begin participation

About This Bone Marrow Edema Study in West Orange

Subchondral bone marrow lesions (BMLs) in knee osteoarthritis (OA) are strongly associated with presence and severity of knee pain, structural deterioration, disease progression with an increased risk of total knee arthroplasty. OA-related BMLs may regress or resolve within 30 months which could be associated with long lasting disability. It has been reported that BMLs persist in the majority of knee OA patients. Different treatment strategies have been proposed including rest and protected weight-bearing, bisphosphonates, subchondroplasty and intraosseous orthobiologic injection. However, conservative treatment response takes a long time and other interventions may be considered invasive procedures that show varying results with several side effects. Focused extracorporeal shockwave therapy (f-ESWT) has been established as a safe non-invasive treatment with positive results in different bone disorders that share the same pathological features of BMLs. This is an exploratory, randomized-controlled, pilot study to determine the efficacy and safety of f-ESWT compared to the standard-of-care (analgesics and protected weight bearing) for the treatment of BMLs in patients with knee OA. Thirty subjects with knee OA who have history of knee pain at rest and during walking with the confirmed diagnosis of subchondral BML(s) on magnetic resonance imaging (MRI) despite at least 4 weeks of conservative treatment will be enrolled into this study. Subjects will receive a total of 4 sessions (at high energy level) over 4 consecutive weeks. Participants will be evaluated for adverse events and changes in pain intensity and knee function, using an 11-point numerical rating scale (NRS; 0-10, with anchors "no pain" and "pain as bad as you can imagine") and; the Knee injury and Osteoarthritis Outcome Score, respectively. Subjects will be assessed with these outcome measures at baseline, 1 month, 2 months, 3 months, and 6 months after the treatment. MRI of the involved knee will be performed prior to treatment (baseline) and 3 months and 6 months after treatment.

Sponsor: Kessler Foundation

Who Can Participate

Inclusion Criteria

Males and females 30-80 years old, inclusive.
Kellgren-Lawrence (KL) score grade 2-4 as diagnosed on X-Ray.
Presence of BML(s) on MRI in a weight-bearing region of the knee (medial/lateral femoral condyle or tibial plateau).
Knee pain for more than 2 months.
Knee pain intensity during the week leading up to the screening visit is at least 4 out of 10 on an 11-point numerical rating scale (NRS; 0, no pain; 10, maximum pain imaginable).
Patient pain confined to the same compartment as the BML(s).
Subjects would have failed a minimum of 4 weeks of conservative treatment including rest, analgesics, limited weight-bearing with or without an assistive device.

Exclusion Criteria

Traumatic BMLs.
Primary cause of patient pain and loss of function is due to pathology other than BML(s), according to patient history and clinical evaluation.
Presence of bilateral BML(s).
Systemic autoimmune diseases, such as systemic lupus erythematosus and rheumatoid arthritis.
Participants receiving glucocorticoids due to any other underlying disease.
Prior treatment for BMLs including:
Subchondroplasty in the involved knee.
Intraosseous and/or intra-articular injection of orthobiologics in the past 6 months, such as platelet rich plasma (PRP), bone marrow aspirate concentrates, micro-fragmented adipose tissue (MFAT) or stromal vascular fraction.
Prior use of bisphosphonates, except according to the washout schedule:
2 years (if use \> 48 weeks).
1 year (if used \> 8 weeks but \< 48 weeks)
6 months (if used \> 2 weeks but \< 8 weeks)
2 months (if used \< 2 weeks)
Any intravenous bisphosphonate within the prior 2 years.
Intra-articular steroid injection in the prior 3 months.
Previous knee surgery in the past 6 months.
Infection or fracture on ipsilateral lower limb.
Contraindications to f-ESWT, such as severe coagulopathy, malignant tumor in the treatment area.
Contraindications to MRI scanning including:
Presence of metal implants such as implanted pacemaker, metal sutures, metallic protheses (including metal pins and rods, heart valves), presence of shrapnel or iron filings in the eye, magnetic dental implants, cochlear implants, cerebral aneurysm clip, and deep brain stimulator.
Claustrophobia.
The patient has been informed by his/her doctor that it is medically unsafe to receive regular MRI as part of his/her medical care.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in West Orange?

Yes, this clinical trial (NCT05596591) has an active research site in West Orange, NJ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Bone Marrow Edema Treatment Options in West Orange, NJ

If you're searching for bone marrow edema treatment options in West Orange, NJ, this clinical trial (NCT05596591) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our West Orange research site is actively enrolling participants for this clinical trial. You'll receive care from experienced bone marrow edema specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all bone marrow edema clinical trials near you to find additional studies recruiting in your area.

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