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

Retro Versus Trans Articular Drilling for Juvenile Osteochondritis Dissecans of the Knee: A Multicenter, Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Juvenile Osteochondritis Dissecans
• Intervention / Treatment: Procedure: Retro-articular drilling; Procedure: Trans-articular drilling

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children
• United States
  • California
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Los Angeles
    • San Diego, California, United States, 92123
      • Rady Children's Hospital
  • Colorado
    • Centennial, Colorado, United States, 80112
      • Rocky Mountain Hospital for Children
  • Connecticut
    • Farmington, Connecticut, United States, 06032
      • Connecticut Children's Medical Center
  • Idaho
    • Boise, Idaho, United States, 83702
      • St. Luke's Children's Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Tennessee Orthopaedic Alliance
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53201
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Physical functioning measured by the Pedi-IKDC (International Knee Documentation Committee) total score	One year post-surgery

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical complications	Inadvertent displacement of OCD fragment; damage to articular cartilage and physes	1 week to 1 year post-surgery

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: The Hospital for Sick Children; Children's Hospital of Philadelphia; University of Pennsylvania; Washington University School of Medicine; Medical College of Wisconsin; Children's Hospital Medical Center, Cincinnati; Kaiser Permanente; Hospital for Special Surgery, New York; Children's Hospital and Health System Foundation, Wisconsin; Rady Children's Hospital, San Diego; Pediatric Orthopaedic Society of North America; Connecticut Children's Medical Center; Tennessee Orthopedic Alliance; St. Luke's Children's Hospital
• Investigators: Principal Investigator: Benton Heyworth, M.D., Boston Children's Hospital

Publications and helpful links

Helpful Links

• Research in OsteoChondritis of the Knee, OCD Study Group of North America

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2013
• Primary Completion (Actual): July 29, 2019
• Study Completion (Actual): October 16, 2020

Study Registration Dates

• First Submitted: December 16, 2012
• First Submitted That Met QC Criteria: December 18, 2012
• First Posted (Estimate): December 21, 2012

Study Record Updates

• Last Update Posted (Actual): December 3, 2020
• Last Update Submitted That Met QC Criteria: December 2, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: osteochondritis dissecans (OCD); juvenile osteochondritis dissecans (JOCD); knee osteochondritis dissecans; retro-articular drilling; trans-articular drilling; stable osteochondritis dissecans lesion
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Bone Diseases; Cartilage Diseases; Osteochondrosis; Osteochondritis; Osteochondritis Dissecans
• Other Study ID Numbers: IRB-P00004016