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Completed

NCT Number: NCT01754298

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

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.

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Key information

Conditions

Juvenile Osteochondritis Dissecans Bone Diseases Musculoskeletal Diseases Osteochondritis Osteochondritis Dissecans

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Retro-articular drilling

Procedure
  • 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

Trans-articular drilling

Procedure
  • 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 outcomes

  1. Physical functioning measured by the Pedi-IKDC (International Knee Documentation Committee) total score

    Time frame: One year post-surgery

Secondary outcomes

  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 outcomes

  1. Surgical complications

    Time frame: 1 week to 1 year post-surgery

    Inadvertent displacement of OCD fragment; damage to articular cartilage and physes

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Children's Hospital Medical Center, Cincinnati
  • Children's Hospital and Health System Foundation, Wisconsin
  • Children's Hospital of Philadelphia
  • Connecticut Children's Medical Center
  • Hospital for Special Surgery, New York
  • Kaiser Permanente
  • Medical College of Wisconsin
  • Pediatric Orthopaedic Society of North America
  • Rady Children's Hospital, San Diego
  • St. Luke's Children's Hospital
  • Tennessee Orthopedic Alliance
  • The Hospital for Sick Children
  • University of Pennsylvania
  • Washington University School of Medicine

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2019
Study completion
2020
First posted
Dec 21, 2012
Registry last updated
Dec 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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