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

Juvenile Osteochondritis Dissecans Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01754298
• Other study ID #: IRB-P00004016
• Status: Completed
• Phase: N/A
• Start date: January 18, 2013
• Est. completion date: October 16, 2020

Study information

• Verified date: December 2020
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: October 16, 2020
• Est. primary completion date: July 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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,

Related Conditions & MeSH terms

• Juvenile Osteochondritis Dissecans
• Osteochondritis
• Osteochondritis Dissecans

Intervention

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.
• 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

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario
United States	St. Luke's Children's Hospital	Boise	Idaho
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Rocky Mountain Hospital for Children	Centennial	Colorado
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Connecticut Children's Medical Center	Farmington	Connecticut
United States	Kaiser Permanente Los Angeles	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Tennessee Orthopaedic Alliance	Nashville	Tennessee
United States	Hospital for Special Surgery	New York	New York
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Rady Children's Hospital	San Diego	California

Sponsors (15)

Lead Sponsor

Collaborator

Boston Children's Hospital

Children's Hospital and Health System Foundation, Wisconsin, Children's Hospital Medical Center, Cincinnati, 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

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Surgical complications	Inadvertent displacement of OCD fragment; damage to articular cartilage and physes	1 week to 1 year post-surgery
Primary	Physical functioning measured by the Pedi-IKDC (International Knee Documentation Committee) total score		One year post-surgery
Secondary	Activity level as measured by the Marx Activity Scale		One year post-surgery
Secondary	Physical functioning as measured by the Pedi-IKDC total score		Two years post-surgery
Secondary	Time to lesion healing	Lesion healing will be assessed by x-ray at multiple time points	3 months to 2 years post-surgery

External Links

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