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New treatment option for Bone Marrow Edema
Official title Focused Extracorporeal Shockwave Therapy for Knee Arthritis
ClinicalTrials.gov ID: NCT05596591
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 80
You may be able to join if
- 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...
You likely can't join if
- 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:
See the full eligibility 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).
- people would have failed a minimum of 4 weeks of conservative treatment including rest, analgesics, limited weight-bearing with or without an assistive device.
- 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...
- 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.
- Tumors
- Infection or fracture on ipsilateral lower limb.
- Pregnancy.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Cedar Knolls, New Jersey, United States
- West Orange, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cedar Knolls, New Jersey, United States; West Orange, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.