Subchondroplasty® Knee RCT

NCT03112200 | Completed

• 1 other identifier: KC.CR.I.AM.16.1
• Study Type: interventional
• Target: 134
• Locations: 2 countries
• Sites: 13

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Superiority will be statistically tested at month 12 at p<0.01

Secondary Outcomes (13)

• Change from baseline KOOS subscale scores at 12 Months

  12 months post-surgery

• Change from baseline Numeric Pain Score at 12 Months

  12 months post-surgery

• Change from baseline EQ-5D score at 12 Months

  12 months post-surgery

• Change from baseline Global Satisfaction score at 12 Months

  12 months post-surgery

• Change from baseline x-rays to 12 Months

  12 months post-surgery

Study Arms (2)

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.

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.

Procedure: Arthroscopy Alone

Interventions

Subchondroplasty with Arthroscopy PROCEDURE

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.

Subchondroplasty with Arthroscopy

Arthroscopy Alone PROCEDURE

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

Arthroscopy Alone

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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)

You may not qualify if:

• 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,
• 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,

Sponsors & Collaborators

• Zimmer Biomet: lead
• MedNet Solutions: collaborator
• Medical Metrics Diagnostics, Inc: collaborator

Study Sites (13)

CORE Orthopaedic Medical Center

Encinitas, California, 92024, United States

Location

Loma Linda University Health System

Loma Linda, California, 92354, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Foundation for Orthopaedic Research and Education

Tampa, Florida, 33637, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612-3833, United States

Location

MedStar Health Research Institute

Timonium, Maryland, 21093, United States

Location

New Mexico Orthopaedic Fellowship Foundation

Albuquerque, New Mexico, 87106, United States

Location

The Ohio State University

Columbus, Ohio, 43202, United States

Location

Hawkins Foundation

Greenville, South Carolina, 29615, United States

Location

Orthopedic Associates of Central Texas

Austin, Texas, 78745, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Research St. Joseph's - Hamilton

Hamilton, Ontario, L8N4A6, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Arthroscopy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures

Study Officials

• Jason Dragoo, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The surgeon will be blinded to the treatment group until the time of surgery to avoid potential selection bias during the screening process. The subject will be blinded to the treatment group. The research coordinator will consult the central randomization list to determine which group the subject is in. Subjects may be randomized prior to surgery to allow for OR set-up. However, randomization should be performed as close to the time of surgery as possible to reduce the risk of randomization failures due to cancelled procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 13, 2017
• Study Start: March 29, 2017
• Primary Completion: August 23, 2023
• Study Completion: August 23, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (12)