Subchondroplasty® Knee RCT

Part of paid clinical trials in Encinitas, California.

Sponsor
Zimmer Biomet
Study ID
NCT03112200
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 75 Years
Healthy Volunteers
Not accepted

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.
  • Arthroscopy Alone — PROCEDURE
    An endoscopic examination, therapy and surgery of the knee joint.

Study Details

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.

Key Dates

Start date
Mar 29, 2017
Status verified
Sep 2023
Primary completion
Aug 23, 2023
Completion
Aug 23, 2023

Study Design

Enrollment
131 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Composite Clinical Success [ Time Frame: Superiority will be statistically tested at month 12 at p<0.01 ]

Locations (12)

FacilityCityStateZIPSite coordinators
CORE Orthopaedic Medical CenterEncinitasCalifornia92024-
Loma Linda University Health SystemLoma LindaCalifornia92354-
Stanford UniversityStanfordCalifornia94305-
Foundation for Orthopaedic Research and EducationTampaFlorida33637-
Emory UniversityAtlantaGeorgia30329-
Rush University Medical CenterChicagoIllinois60612-3833-
MedStar Health Research InstituteTimoniumMaryland21093-
New Mexico Orthopaedic Fellowship FoundationAlbuquerqueNew Mexico87106-
The Ohio State UniversityColumbusOhio43202-
Hawkins FoundationGreenvilleSouth Carolina29615-
Orthopedic Associates of Central TexasAustinTexas78745-
University of VirginiaCharlottesvilleVirginia22903-

Find similar trials in Encinitas, CA

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
CORE Orthopaedic Medical Center· Encinitas, CALoma Linda University Health System· Loma Linda, CAStanford University· Stanford, CAFoundation for Orthopaedic Research and Education· Tampa, FLEmory University· Atlanta, GARush University Medical Center· Chicago, IL

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