Knee Pain ChronicNCT06915363
BioPoly® Partial Resurfacing Knee Implant IDE
A study testing BioPoly in people with Knee Pain Chronic and Knee Osteoarthritis, run by BioPoly LLC at 4 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Knee Pain Chronic, Knee Osteoarthritis, Cartilage Damage
- What is being tested?
- BioPoly
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Mar 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 months of beginning the therapy or failed surgical conservative therapy (e.g. debridement/lavage, marrow stimulation, or alignment high tibial osteotomy) that was performed at least 12 months ago in the index knee and is a candidate for surgical intervention.
- 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 overall depth less than 4mm from the articulating surface.
- 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.
Who cannot join
- 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 has been < 2 months since beginning treatment or the patient's cartilage lesion has failed surgical therapy (e.g. debridement/lavage, marrow stimulation, alignment (high tibial osteotomy)) in the index knee and it has been < 12 months since the surgical treatment.
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- 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 deficits in flexion or extension of > 10 degrees compared to contralateral knee) in the index knee.
- 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 repair is allowed prior to or concurrently with the cartilage treatment procedure if >50% of the functional meniscus remains.).
- 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 inadequate bone stock.
- 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 < -2.5 or QCT T-score < 80mg/cubic cm. History of a fragility fracture requires that a DXA scan or QCT scan is completed
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Washington University Orthopedics
Chesterfield, Missouri, 63017-5701
Susan Brandon, 618.520.0590, sbrandon@wustl.edu
Matthew Matava, MD
- Recruiting
Dupont Hospital
Fort Wayne, Indiana, 46845
Ian Nelson, MD
- Recruiting
OrthoIndy
Indianapolis, Indiana, 46278
Melanie Glover, BSN, 317.802.2880, mglover@orthoindy.com
Troy Roberson, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Noelle Drapeau, 612.741.5893, Drapeau.Noelle2@mayo.edu
Daniel Saris, MD
About this study
Official title: Pivotal, Prospective, Randomized, Controlled, Multicenter Clinical Trial of BioPoly® Partial Resurfacing Knee Implant for Treatment of Focal Cartilage Lesions of the Distal Femur
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:
Read more
- 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.
Researchers will compare the CCS for the investigational device group to a control group receiving the standard of care, either microfracture or debridement).
Subjects randomized to the investigational group will receive the BioPoly Knee device and those randomized to the control group will receive the current standard of care, either microfracture or debridement.
Read the detailed description
The BioPoly® Partial Resurfacing Knee Implant is a surgical intervention when conservative therapies have been ineffective for focal cartilage lesions in the femoral condyles and is an early intervention prior to partial or total joint replacement. It is indicated for focal lesions with healthy surrounding and opposing cartilage. Specifically, the BioPoly® device is intended for the replacement of symptomatic abnormal or severely abnormal (ICRS Grade 2, 3 or 4) chondral or osteochondral focal lesions located in the femoral condyles or trochlear facets in patients between 30 and 65 years of age.
The RCT compares the primary endpoint, Composite Clinical Success criteria, for the investigational device, the BioPoly device, to that of the control group, which is the standard of care for these focal lesions either microfracture or debridement.
For those patients who meet eligibility criteria, randomization is 1:1. For the control group, there is a treatment algorithm to determine if microfracture or debridement that is based upon age of the subject, Kellgren-Lawrence score, and lesion size.
- Conditions
- Knee Pain Chronic, Knee Osteoarthritis, Cartilage Damage, Cartilage Defects of the Knee, Cartilage or Osteochondral Defects in the Knee, Cartilage Lesion
- Being tested
- BioPoly, surgical standard of care (SSOC)
- Keywords
- articular cartilage, cartilage lesion, focal cartilage defect, cartilage defect
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioPolyDevice
partial resurfacing knee replacement
surgical standard of care (SSOC)Procedure or surgery
either microfracture or debridement
| Study group | Role | What they receive |
|---|---|---|
| Investigational | Active comparator | BioPoly Knee device Receives: Device: BioPoly |
| Control | Active comparator | Surgical Standard of Care Group: either Microfracture or debridement procedure Receives: Procedure: surgical standard of care (SSOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in the Knee injury and Osteoarthritis Outcome Score (KOOS) to Assess Composite Clinical Success (CCS) effectiveness
An improvement from baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS) total score (scaled 0 to 100) of at least 10 points. If this criteria is met, the subject will be considered as a success relative to the measure of the Clinical Composite Success for effectiveness.
Measured: 24 months
Composite Clinical Success (CCS) Safety as Measured by No Secondary Surgical Intenvention
No secondary surgical intervention (SSI) by 24 months will be considered as a success for the subject relative to the Composite Clinical Success (CCS) for Safety.
Measured: 24 months
Secondary outcomes (5)
Effectiveness over 24 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS)
KOOS individual component sub-scales (Pain, Symptoms, Activities of Daily Living, Sports/Recreation, Quality of Life) as measured by change from baseline at 6 weeks, 3, 6, 12, and 24 months. The minimum and maximum raw scores for each sub-scale is as follows: Pain = 0-36, Symptoms = 0-28, Activities of Daily Living = 0-38, Sports/Recreation = 20, Quality of Life = 0-16. The sub-scales will be reported on a normalized scale relative the maximum raw score for the particular sub-scale, thus, each sub-scale score will have a range of 0-100 with 100 being better. For instance, a subject's Quality of Life raw score of 12 would be normalized as 12/16 x 100 = 75 points. The reported number will be the difference between the normalized score at a particular timepoint minus the baseline normalized score.
Measured: 24 months
Effectiveness pain reduction over 24 months
Variable Analog Scale (VAS) Pain score as measured by change from baseline at 6 weeks, 3, 6, 12, and 24 months. The VAS Pain score ranges from 0-100 where a lower number is a measure of less pain; so, lower VAS Pain scores are better.
Measured: 24 months
Adverse Events Over 24 Months
- Serious device-related adverse events through 24 months
- Device-related adverse events through 24 months
- Serious adverse events through 24 months
- Unanticipated adverse device effects (UADE) through 24 months
Measured: 24 months
Radiograph review to Assess Implant Stability Over 24 Months
Implant stability over time is assessed by monitoring implant migration/subsidence, implant loosening, and radiolucencies around the implant at 24 months.
Measured: 24 months
Survival Over 24 Months
A survival analysis will be performed to determine the number of treated and control subjects that did not have a secondary surgical intervention to remove the implant or to perform another procedure to treat the same cartilage lesion.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start17 Mar 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Pain ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized 1:1
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioPoly LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herb Schwartz, Ph.D., Study director, BioPoly LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915363
- Sponsor's protocol ID
- 1150117
- Status last verified
- Jul 2026
- First submitted
- 24 Mar 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Sharing of any data will only be in the aggregate.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal, Prospective, Randomized, Controlled, Multicenter Clinical Trial of BioPoly® Partial Resurfacing Knee Implant for Treatment of Focal Cartilage Lesions of the Distal Femur
- ClinicalTrials.gov ID
- NCT06915363
- Acronym / sponsor ID
- 1150117
- Conditions
- Knee Pain Chronic, Knee Osteoarthritis, Cartilage Damage, Cartilage Defects of the Knee, Cartilage or Osteochondral Defects in the Knee, Cartilage Lesion
- Keywords
- articular cartilage, cartilage lesion, focal cartilage defect, cartilage defect
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- BioPoly LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Researchers will compare the CCS for the investigational device group to a control group receiving the standard of care, either microfracture or debridement).
Subjects randomized to the investigational group will receive the BioPoly Knee device and those randomized to the control group will receive the current standard of care, either microfracture or debridement.
Detailed description
The BioPoly® Partial Resurfacing Knee Implant is a surgical intervention when conservative therapies have been ineffective for focal cartilage lesions in the femoral condyles and is an early intervention prior to partial or total joint replacement. It is indicated for focal lesions with healthy surrounding and opposing cartilage. Specifically, the BioPoly® device is intended for the replacement of symptomatic abnormal or severely abnormal (ICRS Grade 2, 3 or 4) chondral or osteochondral focal lesions located in the femoral condyles or trochlear facets in patients between 30 and 65 years of age.
The RCT compares the primary endpoint, Composite Clinical Success criteria, for the investigational device, the BioPoly device, to that of the control group, which is the standard of care for these focal lesions either microfracture or debridement.
For those patients who meet eligibility criteria, randomization is 1:1. For the control group, there is a treatment algorithm to determine if microfracture or debridement that is based upon age of the subject, Kellgren-Lawrence score, and lesion size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized 1:1
| Arm | Type | Receives |
|---|---|---|
| Investigational | Active comparator | Device: BioPolyBioPoly Knee device |
| Control | Active comparator | Procedure: surgical standard of care (SSOC)Surgical Standard of Care Group: either Microfracture or debridement procedure |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 months of beginning the therapy or failed surgical conservative therapy (e.g. debridement/lavage, marrow stimulation, or alignment high tibial osteotomy) that was performed at least 12 months ago in the index knee and is a candidate for surgical intervention.
- Patient has cartilage lesion located in the femoral condyle or trochlear facet.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioPolypartial resurfacing knee replacement | Device | Investigational |
| surgical standard of care (SSOC)either microfracture or debridement | Procedure or surgery | Control |
Primary outcome
Improvement in the Knee injury and Osteoarthritis Outcome Score (KOOS) to Assess Composite Clinical Success (CCS) effectiveness
Time frame: 24 months
An improvement from baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS) total score (scaled 0 to 100) of at least 10 points. If this criteria is met, the subject will be considered as a success relative to the measure of the Clinical Composite Success for effectiveness.
Composite Clinical Success (CCS) Safety as Measured by No Secondary Surgical Intenvention
Time frame: 24 months
No secondary surgical intervention (SSI) by 24 months will be considered as a success for the subject relative to the Composite Clinical Success (CCS) for Safety.
5 secondary outcomes
Effectiveness over 24 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 24 months
Effectiveness pain reduction over 24 months
Time frame: 24 months
Adverse Events Over 24 Months
Time frame: 24 months
Radiograph review to Assess Implant Stability Over 24 Months
Time frame: 24 months
Survival Over 24 Months
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No. Sharing of any data will only be in the aggregate.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Herb Schwartz, Ph.D. study director
BioPoly LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioPoly in people with Knee Pain Chronic and Knee Osteoarthritis, run by BioPoly LLC at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheila Schwartz, R.Ph. (2609996135, sheila@biopolyortho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in the Knee injury and Osteoarthritis Outcome Score (KOOS) to Assess Composite Clinical Success (CCS) effectiveness (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.