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Study of Two Surgical Drilling Techniques to Treat Juvenile Osteochondritis Dissecans of the Knee

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01754298
Recruitment Status : Completed
First Posted : December 21, 2012
Last Update Posted : December 3, 2020
Sponsor:
Collaborators:
Pediatric Orthopaedic Society of North America
University of Pennsylvania
Tennessee Orthopedic Alliance
Children's Hospital Medical Center, Cincinnati
Children's Hospital and Health System Foundation, Wisconsin
Washington University School of Medicine
The Hospital for Sick Children
Children's Hospital of Philadelphia
Kaiser Permanente
Rady Children's Hospital, San Diego
St. Luke's Children's Hospital
Medical College of Wisconsin
Connecticut Children's Medical Center
Hospital for Special Surgery, New York
Information provided by (Responsible Party):
Benton Heyworth, Boston Children's Hospital

Brief Summary:
The purpose of this study is to compare the functional, clinical and radiographic outcomes associated with trans-articular drilling versus retro-articular drilling, two commonly employed techniques of operative treatment for stable forms of juvenile osteochondritis dissecans (JOCD) lesions. This study also aims to better define the natural history of this condition in its most commonly identified pathological state (as a stable lesion) following surgical intervention by determining the rate of radiographic healing and any need for secondary surgery.

Condition or disease Intervention/treatment Phase
Juvenile Osteochondritis Dissecans Procedure: Retro-articular drilling Procedure: Trans-articular drilling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Retro Versus Trans Articular Drilling for Juvenile Osteochondritis Dissecans of the Knee: A Multicenter, Randomized Controlled Trial
Actual Study Start Date : January 18, 2013
Actual Primary Completion Date : July 29, 2019
Actual Study Completion Date : October 16, 2020


Arm Intervention/treatment
Active Comparator: Retro-articular drilling
Retro-articular drilling goes through the cortical margin of the affected condyle, thereby sparing the articular surface and physes.
Procedure: Retro-articular drilling
  • Drilling must be performed under AP and lateral fluoroscopic guidance, with no additional drilling in 'trans-articular', or intra-articular trans-condylar fashion.
  • Use a 0.045 K-wire for drilling.
  • Minimum of 8 wire passes per square centimeter with no maximum number of wire passes.
Other Names:
  • antero-grade
  • extra-articular

Active Comparator: Trans-articular drilling
Trans-articular drilling penetrates the articular cartilage through multiple sites to create subchondral penetrations.
Procedure: Trans-articular drilling
  • Drilling must be performed, under arthroscopic visualization, directly through the articular cartilage, with no additional drilling in 'retro-articular', 'extra-articular', or trans-condylar (through the intercondylar notch)
  • Use a 0.045 K-wire for drilling
  • A minimum 4 wire passes per square centimeter, with a maximum of 5 wire passes per square centimeter
Other Names:
  • antero-grade
  • extra-articular




Primary Outcome Measures :
  1. Physical functioning measured by the Pedi-IKDC (International Knee Documentation Committee) total score [ Time Frame: One year post-surgery ]

Secondary Outcome Measures :
  1. Activity level as measured by the Marx Activity Scale [ Time Frame: One year post-surgery ]
  2. Physical functioning as measured by the Pedi-IKDC total score [ Time Frame: Two years post-surgery ]
  3. Time to lesion healing [ Time Frame: 3 months to 2 years post-surgery ]
    Lesion healing will be assessed by x-ray at multiple time points


Other Outcome Measures:
  1. Surgical complications [ Time Frame: 1 week to 1 year post-surgery ]
    Inadvertent displacement of OCD fragment; damage to articular cartilage and physes



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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of JOCD,
  • Lesion located on the lateral aspect of the medial femoral condyle,
  • Lesion considered stable based on MRI,
  • Patient deemed skeletally immature based on MRI,
  • Completed a course of conservative therapy.

Exclusion Criteria:

  • Significant concomitant knee pathology (AVN, fracture, inflammatory arthritis, ACL tear, discoid/meniscal tear, etc.)
  • Lesion healed sufficiently and surgery is not recommended,
  • Prior surgery on the affected knee,
  • Diagnosis of metabolic bone disorder (e.g. osteogenesis imperfecta),
  • Diagnosis of sickle cell disease,
  • History of prolonged corticosteroid or chemotherapy treatment,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754298


Locations
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United States, California
Kaiser Permanente Los Angeles
Los Angeles, California, United States, 90027
Rady Children's Hospital
San Diego, California, United States, 92123
United States, Colorado
Rocky Mountain Hospital for Children
Centennial, Colorado, United States, 80112
United States, Connecticut
Connecticut Children's Medical Center
Farmington, Connecticut, United States, 06032
United States, Idaho
St. Luke's Children's Hospital
Boise, Idaho, United States, 83702
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Tennessee Orthopaedic Alliance
Nashville, Tennessee, United States, 37205
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53201
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
Boston Children's Hospital
Pediatric Orthopaedic Society of North America
University of Pennsylvania
Tennessee Orthopedic Alliance
Children's Hospital Medical Center, Cincinnati
Children's Hospital and Health System Foundation, Wisconsin
Washington University School of Medicine
The Hospital for Sick Children
Children's Hospital of Philadelphia
Kaiser Permanente
Rady Children's Hospital, San Diego
St. Luke's Children's Hospital
Medical College of Wisconsin
Connecticut Children's Medical Center
Hospital for Special Surgery, New York
Investigators
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Principal Investigator: Benton Heyworth, M.D. Boston Children's Hospital
Additional Information:
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Responsible Party: Benton Heyworth, Instructor in Orthopaedic Surgery, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT01754298    
Other Study ID Numbers: IRB-P00004016
First Posted: December 21, 2012    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: December 2020
Keywords provided by Benton Heyworth, Boston Children's Hospital:
osteochondritis dissecans (OCD)
juvenile osteochondritis dissecans (JOCD)
knee osteochondritis dissecans
retro-articular drilling
trans-articular drilling
stable osteochondritis dissecans lesion
Additional relevant MeSH terms:
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Osteochondritis
Osteochondritis Dissecans
Osteochondrosis
Bone Diseases
Musculoskeletal Diseases
Cartilage Diseases
Connective Tissue Diseases