Subchondroplasty® Knee RCT

Study Purpose

This is a multi-center, prospective, single-blinded, two-arm study, randomized to include 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 30 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Candidates must meet ALL of the following: 1.
Voluntary signature of the Institutional Review Board/Research Ethics Board approved Informed Consent, 2. Male or female subjects between the ages of 30 to 75 years, 3. Body Mass Index ≤ 40 (BMI=kg/m2), 4. Has experienced pain in study knee for at least 3 months, 5. Kellgren-Lawrence grade 1-3 Osteoarthritis, as reviewed on preoperative XR imaging, in the study knee, 6. BML is confirmed on T2 weighted or Proton Density MR Imaging by presence of white signal, 7. 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, 8. Surgical candidate for knee arthroscopy due to mechanical symptoms, meniscus tear, loose body and/or synovitis, 9. 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, 10. Index knee alignment is defined radiographically as one of the following: Neutral, ≤ 6° mechanical varus, or ≤ 6° mechanical valgus, 11. Ligaments in the study knee are stable, 12. The contralateral (non-study) knee is stable and functional, 13. Is refractory to conservative non-surgical management 1. 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) 2. and is ≥ 3 months from the start of treatment, 14. 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.

Exclusion Criteria:

  • - Candidates will be excluded if they meet ANY of the following: 1.
BML caused by acute trauma less than 3 months prior to enrollment, 2. Clinical and/or radiographic disease diagnosis of the index knee that includes any of the following: 1. Kellgren-Lawrence Grade 4 Osteoarthritis with complete loss of joint space (bone-on-bone) or subchondral bone collapse, 2. Rheumatoid arthritis, or history of septic or reactive arthritis, 3. Gout or a history of gout or pseudogout in the affected knee, 4. Has more than two clinically relevant BMLs in the index knee, 5. Osteochondritis dissecans of the knee with significant bone loss, 6. Collapse of subchondral bone, 7. Clinically relevant BML located at ACL/PCL insertion, 8. MRI evidence of frank ligament instability, 3. Passive knee flexion < 110° or flexion contracture >30°, 4. History of systemic diseases which could contribute to secondary arthropathies (e.g., sickle cell disease, hemochromatosis, or autoimmune disease), 5. Has a neuromuscular, neurosensory, or musculoskeletal deficiency that limits the ability to perform objective functional assessment of either knee, 6. If diabetic, blood glucose over 200 mg/dL at time of enrollment, 7. Current daily tobacco or high nicotine product user or < 3 months from nicotine cessation, 8. Presents a high surgical risk due to unstable cardiac and/or pulmonary disease, 9. 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, 10. Is at substantial risk for the need of organ transplantation, such as renal insufficiency, 11. Is pregnant or breast-feeding at the time of surgery, 12. 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, 13. Has primary bone tumor in the knee area, 14. Anticipates having a lower extremity surgery other than the investigational surgery during the course of the study, 15. Is participating concurrently in another clinical trial, or has participated in a clinical trial within 30 days of surgery, 16. 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, 17. Active joint infection or history of chronic joint infection at the surgical site, 18. Prior total meniscectomy of index knee, 19. Has primarily patellofemoral symptoms, 20. 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, 21. Has contraindications for Magnetic Resonance Imaging (MRI), 22. Is receiving worker's compensation or is currently involved in litigation relating to the index knee, 23. Has a history of substance abuse.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03112200
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Zimmer Biomet
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jason Dragoo, MD
Principal Investigator Affiliation University of Colorado, Denver
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Recruiting
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Bone Marrow Edema, Knee Pain Chronic, Knee Osteoarthritis, Osteoarthritis, Knee, Osteoarthritis
Study Website: View Trial Website
Additional Details

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.#46; 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 will occur at the study site at 6 weeks, 3 months, 6 months, 12 months, and 24 months post-surgery. Telephone follow-up interviews will be done at 9 and 18 months post-surgery. Target enrollment is 201 subjects, to include 134 subjects in the treatment group (Subchondroplasty + Arthroscopy) and 67 subjects in the control group (Arthroscopy alone). 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.

Arms & Interventions

Arms

Active Comparator: Subchondroplasty with Arthroscopy

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.

Sham Comparator: Arthroscopy Alone

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.

Interventions

Procedure: - Subchondroplasty with Arthroscopy

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.

Procedure: - Arthroscopy Alone

An endoscopic examination, therapy and surgery of the knee joint.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

CORE Orthopaedic Medical Center, Encinitas, California

Status

Recruiting

Address

CORE Orthopaedic Medical Center

Encinitas, California, 92024

Site Contact

Farouk Awad

[email protected]

760-943-6700 #162

Loma Linda University Health System, Loma Linda, California

Status

Recruiting

Address

Loma Linda University Health System

Loma Linda, California, 92354

Site Contact

Elisabeth Clarke

[email protected]

909-558-5592

Stanford University, Stanford, California

Status

Recruiting

Address

Stanford University

Stanford, California, 94305

Site Contact

Taylor Ray

[email protected]

650-721-7653

Shrock Orthopedic Research, Fort Lauderdale, Florida

Status

Recruiting

Address

Shrock Orthopedic Research

Fort Lauderdale, Florida, 33316

Site Contact

Jennifer Motes

[email protected]

954-626-3743

Tampa, Florida

Status

Recruiting

Address

Foundation for Orthopaedic Research and Education

Tampa, Florida, 33637

Site Contact

Debbi Warren, RN

[email protected]

813-978-9700 #6766

Emory University, Atlanta, Georgia

Status

Recruiting

Address

Emory University

Atlanta, Georgia, 30329

Site Contact

Lavanya Veda

[email protected]

404-778-6608

Rush University Medical Center, Chicago, Illinois

Status

Recruiting

Address

Rush University Medical Center

Chicago, Illinois, 60612-3833

Site Contact

Kavita Ahuja

[email protected]

312-563-2214

Anne Arundel Research Institute, Inc., Annapolis, Maryland

Status

Recruiting

Address

Anne Arundel Research Institute, Inc.

Annapolis, Maryland, 21401

Site Contact

Michaline West

[email protected]

484-467-7047

MedStar Health Research Institute, Timonium, Maryland

Status

Recruiting

Address

MedStar Health Research Institute

Timonium, Maryland, 21093

Site Contact

Flossine Brown

[email protected]

410-554-4451

Albuquerque, New Mexico

Status

Recruiting

Address

New Mexico Orthopaedic Fellowship Foundation

Albuquerque, New Mexico, 87106

Site Contact

Natalie R Munson

[email protected]

505-724-3201

The Ohio State University, Columbus, Ohio

Status

Recruiting

Address

The Ohio State University

Columbus, Ohio, 43202

Site Contact

Angela Pedroza

[email protected]

614-293-7952

Oregon Health & Science University, Portland, Oregon

Status

Recruiting

Address

Oregon Health & Science University

Portland, Oregon, 97239

Site Contact

Kaytee Arnold

[email protected]

503-418-9580

Rothman Orthopaedic Institute, Philadelphia, Pennsylvania

Status

Recruiting

Address

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107

Site Contact

Janet Rhee

[email protected]

267-339-3601

Hawkins Foundation, Greenville, South Carolina

Status

Recruiting

Address

Hawkins Foundation

Greenville, South Carolina, 29615

Site Contact

Kyle Adams, BS

[email protected]

864-454-7458

Orthopedic Associates of Central Texas, Austin, Texas

Status

Recruiting

Address

Orthopedic Associates of Central Texas

Austin, Texas, 78745

Site Contact

Elizabeth Eichman

[email protected]

484-467-7047

University of Utah, Salt Lake City, Utah

Status

Recruiting

Address

University of Utah

Salt Lake City, Utah, 84108

Site Contact

Tope Adeyemi

[email protected]

484-467-7047

University of Virginia, Charlottesville, Virginia

Status

Recruiting

Address

University of Virginia

Charlottesville, Virginia, 22903

Site Contact

Kaitlyn Shank

[email protected]

434-243-5653

Jordan Research Foundation, Virginia Beach, Virginia

Status

Recruiting

Address

Jordan Research Foundation

Virginia Beach, Virginia, 23462

Site Contact

Carolyn Battaglia

[email protected]

757-502-8586

International Sites

Research St. Joseph's - Hamilton, Hamilton, Ontario, Canada

Status

Recruiting

Address

Research St. Joseph's - Hamilton

Hamilton, Ontario, L8N4A6

Site Contact

Breanne Flood

[email protected]

416-627-9367