Bone Marrow EdemaPRESERVE KneeNCT03112200
Subchondroplasty® Knee RCT
A study testing Subchondroplasty with Arthroscopy and Arthroscopy Alone in people with Bone Marrow Edema and Knee Pain Chronic, run by Zimmer Biomet at 13 sites in 2 countries.
Trial summary
This is a multi-center, prospective, single-blinded, two-arm study, randomized to include approximately 134 subjects treated with Subchondroplasty (SCP) + Arthroscopy and 67 subjects with arthroscopy alone. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Bone Marrow Edema, Knee Pain Chronic, Knee Osteoarthritis
- What is being tested?
- Subchondroplasty with Arthroscopy and Arthroscopy Alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 29 Mar 2017to 23 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates must meet ALL of the following:
- Voluntary signature of the Institutional Review Board/Research Ethics Board approved Informed Consent,
- Male or female subjects between the ages of 30 to 75 years,
- Body Mass Index ≤ 40 (BMI=kg/m2),
- Has experienced pain in study knee for at least 3 months,
- Kellgren-Lawrence grade 1-3 Osteoarthritis, as reviewed on preoperative XR imaging, in the study knee,
Show all 17Show fewer
- BML is confirmed on T2 weighted or Proton Density MR Imaging by presence of white signal,
- Single BML of tibia, single BML of femur, or adjoining BML's of tibia \& femur, in the same compartment, extending to the articular surface of the joint,
- Surgical candidate for knee arthroscopy due to mechanical symptoms, meniscus tear, loose body and/or synovitis,
- Must record a response, at the preoperative study visit, of moderate to extreme pain for any one of the KOOS Pain Scale questions, P2 through P9,
- Index knee alignment is defined radiographically as one of the following: Neutral, ≤ 6° mechanical varus, or ≤ 6° mechanical valgus,
- Ligaments in the study knee are stable,
- The contralateral (non-study) knee is stable and functional,
- Is refractory to conservative non-surgical management
- having failed 2 or more of the following: hyaluronic acid injection, corticosteroid injection, NSAIDs, physical therapy, bracing, activity modification, or minimal surgical intervention (e.g., arthroscopy, debridement/chondroplasty, and/or loose body removal)
- and is ≥ 3 months from the start of treatment,
- Must be physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to be compliant with the protocol - including all follow-up visits, survey completion, weight-bearing restrictions, and post-operative rehabilitation.
Who cannot join
- Candidates will be excluded if they meet ANY of the following:
- BML caused by acute trauma less than 3 months prior to enrollment,
- Clinical and/or radiographic disease diagnosis of the index knee that includes any of the following:
- Kellgren-Lawrence Grade 4 Osteoarthritis with complete loss of joint space (bone-on-bone) or subchondral bone collapse,
- Rheumatoid arthritis, or history of septic or reactive arthritis,
- Gout or a history of gout or pseudogout in the affected knee,
Show all 32Show fewer
- Has more than two clinically relevant BMLs in the index knee,
- Osteochondritis dissecans of the knee with significant bone loss,
- Collapse of subchondral bone,
- Clinically relevant BML located at ACL/PCL insertion,
- MRI evidence of frank ligament instability,
- Passive knee flexion < 110° or flexion contracture >30°,
- History of systemic diseases which could contribute to secondary arthropathies (e.g., sickle cell disease, hemochromatosis, or autoimmune disease),
- Has a neuromuscular, neurosensory, or musculoskeletal deficiency that limits the ability to perform objective functional assessment of either knee,
- If diabetic, blood glucose over 200 mg/dL at time of enrollment,
- Current daily tobacco or high nicotine product user or < 3 months from nicotine cessation,
- Presents a high surgical risk due to unstable cardiac and/or pulmonary disease,
- Has HIV or other immunodeficient state including subjects on immunosuppressant therapies, or has significant illness (metastasis of any type) that decreases the probability of survival to the 2 year endpoint,
- Is at substantial risk for the need of organ transplantation, such as renal insufficiency,
- Is pregnant or breast-feeding at the time of surgery,
- Has a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for 5 years,
- Has primary bone tumor in the knee area,
- Anticipates having a lower extremity surgery other than the investigational surgery during the course of the study,
- Is participating concurrently in another clinical trial, or has participated in a clinical trial within 30 days of surgery,
- Is receiving prescription pain medication other than NSAIDs or acetaminophen for conditions unrelated to the index knee condition, chronic use of anticoagulants, or taking corticosteroids,
- Active joint infection or history of chronic joint infection at the surgical site,
- Prior total meniscectomy of index knee,
- Has primarily patellofemoral symptoms,
- Is indicated for concomitant procedures (i.e., microfracture, subchondral drilling, cartilage allograft, ligament or tendon repair, distal realignment/osteotomy, root repair) in the index knee, with the exception of incidental loose body removal, debridement, synovectomy, osteophyte removal in locations other than adjacent to BMLs, and/or partial meniscectomy,
- Has contraindications for Magnetic Resonance Imaging (MRI),
- Is receiving worker's compensation or is currently involved in litigation relating to the index knee,
- Has a history of substance abuse.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
New Mexico Orthopaedic Fellowship Foundation
Albuquerque, New Mexico, 87106
Emory University
Atlanta, Georgia, 30329
Orthopedic Associates of Central Texas
Austin, Texas, 78745
University of Virginia
Charlottesville, Virginia, 22903
Rush University Medical Center
Chicago, Illinois, 60612-3833
The Ohio State University
Columbus, Ohio, 43202
CORE Orthopaedic Medical Center
Encinitas, California, 92024
Hawkins Foundation
Greenville, South Carolina, 29615
Loma Linda University Health System
Loma Linda, California, 92354
Stanford University
Stanford, California, 94305
Foundation for Orthopaedic Research and Education
Tampa, Florida, 33637
MedStar Health Research Institute
Timonium, Maryland, 21093
About this study
Official title: A Randomized Controlled Trial of the Subchondroplasty® Procedure With Arthroscopy Versus Arthroscopy Alone for Treatment of Bone Marrow Lesions in the Knee
This is a multi-center, prospective, single-blinded, two-arm study, randomized to include approximately 134 subjects treated with Subchondroplasty (SCP) + Arthroscopy and 67 subjects with arthroscopy alone.
The primary objective of this study is to demonstrate superiority of Subchondroplasty with arthroscopy compared to arthroscopy alone for treatment of Bone Marrow Lesions (BMLs) in the knee.
Read the detailed description
This is a multicenter, prospective, single-blinded, two-arm, randomized study. Enrolled subjects will have a single Bone Marrow Lesion of the tibia, single BML of the femur, or adjoining Bone Marrow Lesions of tibia and femur. Subjects will also be surgical candidates for knee arthroscopy due to mechanical symptoms, meniscus tear, loose body and/or synovitis.
A stratified blocked randomization will be used to assign subjects to either Subchondroplasty with arthroscopy or to arthroscopy alone in a 2:1 ratio. Individual sets of blocks will be determined within study site and lesion polarity status (unipolar vs. bipolar).
Subjects will be enrolled within 60 days prior to surgery and take part in follow-up visits for two years following surgery. A preoperative visit will occur at the time of enrollment. Follow-up visits were to initially occur at the study site at 6 weeks, 3 months, 6 months, 12 months, and 24 months post-surgery. Telephone follow-up interviews to be be performed at 9 and 18 months post-surgery. Target enrollment was 201 subjects, to include 134 subjects in the treatment group (Subchondroplasty + Arthroscopy) and 67 subjects in the control group (Arthroscopy alone).
As of October 2020, follow-up has been amended to be completed remotely, where all visits can be performed electronically and/or via telephone.
Subjects will complete the study at the 24 month follow-up visit. For the purposes of this protocol, a revision will be defined as any partial or total joint arthroplasty or any bone fixation, bone grafting or bone substitute procedure in the same compartment in the study knee.
- Conditions
- Bone Marrow Edema, Knee Pain Chronic, Knee Osteoarthritis, Osteoarthritis, Knee, Osteoarthritis
- Being tested
- Subchondroplasty with Arthroscopy, Arthroscopy Alone
- Keywords
- Subchondroplasty, Arthroscopy, Bone Substitute Material, Subchondral Bone Defect, AccuFill, Bone Marrow Lesion, Knee Replacement, Knee Replacement Alternative
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subchondroplasty with ArthroscopyProcedure or surgery
The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process.
Arthroscopy AloneProcedure or surgery
An endoscopic examination, therapy and surgery of the knee joint.
| Study group | Role | What they receive |
|---|---|---|
| Subchondroplasty with Arthroscopy | Active comparator | After randomization to the study group, subjects assigned to the Subchondroplasty + Arthroscopy group will undergo the Subchondroplasty portion of the procedure before or after the Arthroscopy portion per the surgeon's discretion. All operative procedures are to be performed under aseptic conditions according to the institution's standards. Receives: Procedure: Subchondroplasty with Arthroscopy |
| Arthroscopy Alone | Sham comparator | After randomization, subjects assigned to the Arthroscopy control group will undergo arthroscopy of the study knee with one or more of the following procedures:
* Partial meniscectomy
* Lavage
* Debridement
* Loose body removal
* Synovectomy
* Removal of osteophytes in the notch or locations other than those adjacent to BML(s)
Superficial skin incision(s) should be created at the typical AccuPort® access point(s) as if the subject had undergone Subchondroplasty. The incisions should be closed in the typical fashion. Receives: Procedure: Arthroscopy Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Clinical Success
The primary objective of this study is to determine whether Subchondroplasty with arthroscopy is superior to arthroscopy alone for treatment of bone marrow lesions in the knee.
Superiority will be evaluated in terms of Composite Clinical Success (CCS) requiring freedom from subsequent secondary surgical intervention (SSSI) and among those free from SSSI, a clinically meaningful reduction in self-reported pain based on a validated measure of subject-reported pain (improvement in KOOS (Knee Injury and Osteoarthritis Outcome Score) pain of at least 10 points at 12 months).
For the purpose of this study, SSSI will include any partial or total joint arthroplasty or any bone grafting or bone substitute procedure in the study knee.
Measured: Superiority will be statistically tested at month 12 at p<0.01
Secondary outcomes (12)
Change From Baseline KOOS Subscale Scores at 12 Months
Comparison of mean change in KOOS subscale scores (Pain, Activities of Daily Living), Symptoms, Sports and Recreation, Quality of Life). Each subscale is scored from 0 to 100 on a worst to best scale.
Measured: 12 months post-surgery
Change From Baseline Numeric Pain Score at 12 Months
Comparison of mean Numeric Pain Score (NPS). The NPS is scored from 0 to 10 where 0 indicates no pain; 5 indicates moderate pain; and 10 indicates the worst pain.
Measured: 12 months post-surgery
Change From Baseline EQ-5D Index Score at 12 Months
Comparison of mean EQ-5D Index score
Measured: 12 months post-surgery
Global Satisfaction Score at 6-Weeks
Patient satisfaction with knee procedure rated on a 0-10 scale, where 0 = totally dissatisfied and 10 = extremely satisfied.
Measured: 6-weeks post-surgery
Change From Baseline KOOS Subscale Scores at 24 Months
Comparison of mean change in KOOS subscale scores (Pain, Activities of Daily Living), Symptoms, Sports and Recreation, Quality of Life). Each subscale is scored from 0 to 100 on a worst to best scale.
Measured: 24 months post-surgery
Change From Baseline Numeric Pain Score at 24 Months
Comparison of mean Numeric Pain Score (NPS). The NPS is scored from 0 to 10 where 0 indicates no pain; 5 indicates moderate pain; and 10 indicates the worst pain.
Measured: 24 months post-surgery
Change From Baseline EQ-5D Overall Health Score at 12 Months
Comparison of mean EQ-5D Overall Health score using the EQ Visual Analog Scale (VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health).
Measured: 12 months post-surgery
Change From Baseline EQ-5D Overall Health Score at 24 Months
Comparison of mean EQ-5D Overall Health score using the EQ Visual Analog Scale (VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health).
Measured: 24 months post-surgery
Global Satisfaction Score at 3 Months
Patient satisfaction with knee procedure rated on a 0-10 scale, where 0 = totally dissatisfied and 10 = extremely satisfied.
Measured: 3 Months post-surgery
Global Satisfaction Score at 6 Months
Patient satisfaction with knee procedure rated on a 0-10 scale, where 0 = totally dissatisfied and 10 = extremely satisfied.
Measured: 6 months post-surgery
Global Satisfaction Score at 12 Months
Patient satisfaction with knee procedure rated on a 0-10 scale, where 0 = totally dissatisfied and 10 = extremely satisfied.
Measured: 12 months post-surgery
Global Satisfaction Score at 24 Months
Patient satisfaction with knee procedure rated on a 0-10 scale, where 0 = totally dissatisfied and 10 = extremely satisfied.
Measured: 24 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start29 Mar 2017
- Primary completion23 Aug 2023
- Study completion23 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bone Marrow EdemaStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- A stratified blocked randomization will be used to assign subjects to either Subchondroplasty with arthroscopy or to arthroscopy alone in a 2:1 ratio. Individual sets of blocks will be determined within study site and lesion polarity status (unipolar vs. bipolar).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MedNet Solutions, Medical Metrics Diagnostics, Inc
- Responsible party
- Sponsor
- Investigators
- Jason Dragoo, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112200
- Sponsor's protocol ID
- KC.CR.I.AM.16.1
- Acronym
- PRESERVE Knee
- Status last verified
- Sep 2023
- First submitted
- 27 Mar 2017
- Last updated
- 14 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Subchondroplasty® Procedure With Arthroscopy Versus Arthroscopy Alone for Treatment of Bone Marrow Lesions in the Knee
- ClinicalTrials.gov ID
- NCT03112200
- Acronym / sponsor ID
- PRESERVE Knee / KC.CR.I.AM.16.1
- Conditions
- Bone Marrow Edema, Knee Pain Chronic, Knee Osteoarthritis, Osteoarthritis, Knee, Osteoarthritis
- Keywords
- Subchondroplasty, Arthroscopy, Bone Substitute Material, Subchondral Bone Defect, AccuFill, Bone Marrow Lesion, Knee Replacement, Knee Replacement Alternative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- MedNet Solutions, Medical Metrics Diagnostics, Inc
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 13 Apr 2017 (actual)
- Results
- Posted 14 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, prospective, single-blinded, two-arm study, randomized to include approximately 134 subjects treated with Subchondroplasty (SCP) + Arthroscopy and 67 subjects with arthroscopy alone.
The primary objective of this study is to demonstrate superiority of Subchondroplasty with arthroscopy compared to arthroscopy alone for treatment of Bone Marrow Lesions (BMLs) in the knee.
Detailed description
This is a multicenter, prospective, single-blinded, two-arm, randomized study. Enrolled subjects will have a single Bone Marrow Lesion of the tibia, single BML of the femur, or adjoining Bone Marrow Lesions of tibia and femur. Subjects will also be surgical candidates for knee arthroscopy due to mechanical symptoms, meniscus tear, loose body and/or synovitis.
A stratified blocked randomization will be used to assign subjects to either Subchondroplasty with arthroscopy or to arthroscopy alone in a 2:1 ratio. Individual sets of blocks will be determined within study site and lesion polarity status (unipolar vs. bipolar).
Subjects will be enrolled within 60 days prior to surgery and take part in follow-up visits for two years following surgery. A preoperative visit will occur at the time of enrollment. Follow-up visits were to initially occur at the study site at 6 weeks, 3 months, 6 months, 12 months, and 24 months post-surgery. Telephone follow-up interviews to be be performed at 9 and 18 months post-surgery. Target enrollment was 201 subjects, to include 134 subjects in the treatment group (Subchondroplasty + Arthroscopy) and 67 subjects in the control group (Arthroscopy alone).
As of October 2020, follow-up has been amended to be completed remotely, where all visits can be performed electronically and/or via telephone.
Subjects will complete the study at the 24 month follow-up visit. For the purposes of this protocol, a revision will be defined as any partial or total joint arthroplasty or any bone fixation, bone grafting or bone substitute procedure in the same compartment in the study knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A stratified blocked randomization will be used to assign subjects to either Subchondroplasty with arthroscopy or to arthroscopy alone in a 2:1 ratio. Individual sets of blocks will be determined within study site and lesion polarity status (unipolar vs. bipolar).
| Arm | Type | Receives |
|---|---|---|
| Subchondroplasty with Arthroscopy | Active comparator | Procedure: Subchondroplasty with ArthroscopyAfter randomization to the study group, subjects assigned to the Subchondroplasty + Arthroscopy group will undergo the Subchondroplasty portion of the procedure before or after the Arthroscopy portion per the surgeon's discretion. All operative procedures are to be performed under aseptic conditions according to the institution's standards. |
| Arthroscopy Alone | Sham comparator | Procedure: Arthroscopy AloneAfter randomization, subjects assigned to the Arthroscopy control group will undergo arthroscopy of the study knee with one or more of the following procedures: * Partial meniscectomy * Lavage * Debridement * Loose body removal * Synovectomy * Removal of osteophytes in the notch or locations other than those adjacent to BML(s) Superficial skin incision(s) should be created at the typical AccuPort® access point(s) as if the subject had undergone Subchondroplasty. The incisions should be closed in the typical fashion. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Candidates must meet ALL of the following:
Key exclusion criteria (32 listed)
- Candidates will be excluded if they meet ANY of the following:
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 |
|---|---|---|
| Subchondroplasty with ArthroscopyThe Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process. | Procedure or surgery | Subchondroplasty with Arthroscopy |
| Arthroscopy AloneAn endoscopic examination, therapy and surgery of the knee joint. | Procedure or surgery | Arthroscopy Alone |
Primary outcome
Composite Clinical Success
Time frame: Superiority will be statistically tested at month 12 at p<0.01
The primary objective of this study is to determine whether Subchondroplasty with arthroscopy is superior to arthroscopy alone for treatment of bone marrow lesions in the knee. Superiority will be evaluated in terms of Composite Clinical Success (CCS) requiring freedom from subsequent secondary surgical intervention (SSSI) and among those free from SSSI, a clinically meaningful reduction in self-reported pain based on a validated measure of subject-reported pain (improvement in KOOS (Knee Injury and Osteoarthritis Outcome Score) pain of at least 10 points at 12 months). For the purpose of this study, SSSI will include any partial or total joint arthroplasty or any bone grafting or bone substitute procedure in the study knee.
12 secondary outcomes
Change From Baseline KOOS Subscale Scores at 12 Months
Time frame: 12 months post-surgery
Change From Baseline Numeric Pain Score at 12 Months
Time frame: 12 months post-surgery
Change From Baseline EQ-5D Index Score at 12 Months
Time frame: 12 months post-surgery
Global Satisfaction Score at 6-Weeks
Time frame: 6-weeks post-surgery
Change From Baseline KOOS Subscale Scores at 24 Months
Time frame: 24 months post-surgery
Change From Baseline Numeric Pain Score at 24 Months
Time frame: 24 months post-surgery
Change From Baseline EQ-5D Overall Health Score at 12 Months
Time frame: 12 months post-surgery
Change From Baseline EQ-5D Overall Health Score at 24 Months
Time frame: 24 months post-surgery
Global Satisfaction Score at 3 Months
Time frame: 3 Months post-surgery
Global Satisfaction Score at 6 Months
Time frame: 6 months post-surgery
Global Satisfaction Score at 12 Months
Time frame: 12 months post-surgery
Global Satisfaction Score at 24 Months
Time frame: 24 months post-surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jason Dragoo, MD principal investigator
University of Colorado, Denver
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subchondroplasty with Arthroscopy and Arthroscopy Alone in people with Bone Marrow Edema and Knee Pain Chronic, run by Zimmer Biomet at 13 sites in 2 countries.
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 17 inclusion and 32 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: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 14 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Clinical Success (time frame: Superiority will be statistically tested at month 12 at p<0.01). 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 14 May 2026.