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

Not Applicable

Completed

• Conditions: Juvenile Osteochondritis Dissecans
• Interventions: Procedure: Trans-articular drilling; Procedure: Retro-articular drilling

• Registration Number: NCT01754298
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-16
• Study First Submitted QC: 2012-12-18
• Study First Posted: 2012-12-21
• Study Start: 2013-01-18
• Primary Completion: 2019-07-29
• Study Completion: 2020-10-16
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-02
• Last Update Posted: 2020-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trans-articular drilling	Trans-articular drilling	Trans-articular drilling penetrates the articular cartilage through multiple sites to create subchondral penetrations.
Retro-articular drilling	Retro-articular drilling	Retro-articular drilling goes through the cortical margin of the affected condyle, thereby sparing the articular surface and physes.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (14)

Rady Children's Hospital; 🇺🇸 San Diego, California, United States

Kaiser Permanente Los Angeles; 🇺🇸 Los Angeles, California, United States

Connecticut Children's Medical Center; 🇺🇸 Farmington, Connecticut, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

St. Luke's Children's Hospital; 🇺🇸 Boise, Idaho, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Hospital for Special Surgery; 🇺🇸 New York, New York, United States

Rocky Mountain Hospital for Children; 🇺🇸 Centennial, Colorado, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Tennessee Orthopaedic Alliance; 🇺🇸 Nashville, Tennessee, United States