BridgeMD
New treatment option for Knee Pain Chronic
Official title BioPoly® Partial Resurfacing Knee Implant IDE
ClinicalTrials.gov ID: NCT06915363
What this study is testing
- What it's testing
- The goal of this randomized controlled clinical trial is to demonstrate the safety and effectiveness of the BioPoly® Partial Resurfacing Knee Implant for the treatment of cartilage defects of the distal femur in adult patients with knee pain and symptoms who are candidates for surgical intervention of the knee compared to outcomes for the control group. The primary effectiveness endpoint is Month 24 composite clinical success (CCS) defined by: no secondary surgical intervention (SSI) and an improvement from baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS) total score (scaled 0 to 100) of at least 10 points.
- 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 65
You may be able to join if
- Patient is between 30 and 65 years of age25.
- KOOS quality of life score ≤ 60.
- In the opinion of the Investigator, the patient has the understanding and willingness to comply with all study requirements including the...
- Patient has cartilage lesion that has failed non-surgical conservative therapy (e,g, anti-inflammatory (NSAID), viscosupplementation, steroid...
- Patient has cartilage lesion located in the femoral condyle or trochlear facet.
You likely can't join if
- Patient has body mass index (BMI) ≥ 35.
- Patient has autoimmune arthritis, as diagnosed by Investigator.
- Patient has advanced degenerative osteoarthritis in index knee (Kellgren-Lawrence Grade 4 and/or diagnosed intraoperatively).
- Contralateral knee is known to have symptomatic cartilage, meniscal, or ligamentous lesions, generalized osteoarthritis, or requires surgery.
- Patient has gout, by Investigator diagnosis or patient-reported history within last 12 months.
- Patient has a cartilage lesion that is being treated with a non-surgical conservative therapy (e,g, anti-inflammatory (NSAID), viscosupplementation...
See the full eligibility criteria
Who can join
- Patient is between 30 and 65 years of age25.
- KOOS quality of life score ≤ 60.
- In the opinion of the Investigator, the patient has the understanding and willingness to comply with all study requirements including the Post-Operative rehabilitation and follow-up protocol.
- Patient has cartilage lesion that has failed non-surgical conservative therapy (e,g, anti-inflammatory (NSAID), viscosupplementation, steroid injection, physical therapy, or activity modification) after at least 2...
- Patient has cartilage lesion located in the femoral condyle or trochlear facet.
- Patient has lesion(s) classified as ICRS grade 2, 3 or 4.
- Patient's lesion size may not exceed 3.1 cm2 and must be circumscribed by a 1.5 cm or 2.0 cm diameter circle, or 1.5 cm (M-L) by 2.4 cm (A-P) oval of normal or nearly normal (ICRS grade 0 or 1) cartilage, with an...
- Patient has subchondral bone quality that is non-osteoporotic and is sufficient to support the implant. The quality of bone will be assessed by the surgeon intraoperatively with a surgical instrument such as an awl.
What rules you out
- Patient has body mass index (BMI) ≥ 35.
- Patient has autoimmune arthritis, as diagnosed by Investigator.
- Patient has advanced degenerative osteoarthritis in index knee (Kellgren-Lawrence Grade 4 and/or diagnosed intraoperatively).
- Contralateral knee is known to have symptomatic cartilage, meniscal, or ligamentous lesions, generalized osteoarthritis, or requires surgery.
- Patient has gout, by Investigator diagnosis or patient-reported history within last 12 months.
- Patient has a cartilage lesion that is being treated with a non-surgical conservative therapy (e,g, anti-inflammatory (NSAID), viscosupplementation, steroid injection, physical therapy, or activity modification) and it...
- Patient has a cartilage lesion that is being treated that has failed ACI, OATS or Allograft treatment.
- Patient has malalignment of the index knee (\>5 degrees weight bearing varus or valgus).
- Patient has bipolar articular cartilage involvement (or kissing lesions) of the ipsilateral compartment (i.e. greater than ICRS Grade 2 on the opposing articular surface) in the index knee.
- Patient has uncorrected ligamentous instability (good joint stability in the index joint with a Grade 1 Lachman or less, no pivot shift for ACL insufficiency and no posterior translation of more than grade 1; no...
- Patient has undergone a total meniscectomy of index knee.
- Patient has undergone patellofemoral arthroplasty of the index knee
- Patient currently reports or has a documented history of uncontrolled diabetes.
- Patient currently has any condition, therapy, or medication known to impair bone healing.
- Patient has had an active systemic infection or joint infection in index knee over the last 12 months.
- Patient has an allergy to titanium alloy (Ti-6Al-4V), ultrahigh molecular weight polyethylene (UHMWPE), or hyaluronan/ hyaluronic acid (HA).
- Patient is pregnant or is planning to become pregnant (for female patients only) at any point during the duration of the study.
- Patient has legal involvement or any other issue that would hinder completion of the two-year follow-up period.
- Patient is participating in other studies and/or receiving any other simultaneous therapy in index knee.
- Patient has an uncorrected tear of the meniscus of the index knee. (Partial meniscectomy that retains \>50% of the meniscus is allowed prior to or concurrently with the cartilage treatment procedure. Meniscus suture...
- Patient has an additional cartilage lesion(s) (ICRS Grade 3 or 4) in the index knee, located on the patella, trochlea, tibia, or non-weight bearing area of index condyle that requires treatment.
- More than one implant is required to accommodate defect in the index knee.
- Patient has inadequate bone stock (e.g., cysts, osteoporosis) underlying the lesion site as determined intra-operatively by the investigator
- As determined by the investigator through use of an awl or a similar instrument to determine if the bone quality is insufficient to support the BioPoly device.
- If the cause of inadequate bone stock is due to cysts or to the boney portion of an osteochondral lesion being excessive, then the investigator may opt to fix the implant with cement rather than exclude the patient for...
- Patients with osteoporosis, osteopenia, Paget's disease, osteomalacia or any other metabolic bone disease; a. Osteoporosis is defined as Simple Calculated Osteoporosis Risk Estimation (SCORE) above 6 and DXA T-score \<...
The study team makes the final eligibility decision.
Where it's taking place
- Fort Wayne, Indiana, United States
- Indianapolis, Indiana, United States
- Rochester, Minnesota, United States
- Chesterfield, Missouri, 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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fort Wayne, Indiana, United States; Indianapolis, Indiana, United States; Rochester, Minnesota, United States; Chesterfield, Missouri, 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.