Clinical trial NCT01754298: Study of Two Surgical Drilling Techniques to Treat Juvenile Osteochondritis Dissecans of the Knee
Official title: Retro Versus Trans Articular Drilling for Juvenile Osteochondritis Dissecans of the Knee: A Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Juvenile Osteochondritis Dissecans
Keywords: osteochondritis dissecans (OCD)
juvenile osteochondritis dissecans (JOCD)
knee osteochondritis dissecans
retro-articular drilling
trans-articular drilling
stable osteochondritis dissecans lesion
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Pediatric Orthopaedic Society of North America
name: University of Pennsylvania
name: Tennessee Orthopedic Alliance
name: Children's Hospital Medical Center, Cincinnati
name: Children's Hospital and Health System Foundation, Wisconsin
name: Washington University School of Medicine
name: The Hospital for Sick Children
name: Children's Hospital of Philadelphia
name: Kaiser Permanente
name: Rady Children's Hospital, San Diego
name: St. Luke's Children's Hospital
name: Medical College of Wisconsin
name: Connecticut Children's Medical Center
name: Hospital for Special Surgery, New York
First posted: 2012-12-21
Enrollment: 91
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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,

Primary outcomes:
measure: Physical functioning measured by the Pedi-IKDC (International Knee Documentation Committee) total score
timeFrame: One year post-surgery
Secondary outcomes:
measure: Activity level as measured by the Marx Activity Scale
timeFrame: One year post-surgery
measure: Physical functioning as measured by the Pedi-IKDC total score
timeFrame: Two years post-surgery
measure: Time to lesion healing
timeFrame: 3 months to 2 years post-surgery
Other outcomes:
measure: Surgical complications
timeFrame: 1 week to 1 year post-surgery
Locations:
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: Centennial
country: United States
facility: Rocky Mountain Hospital for Children
state: Colorado
city: Farmington
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Boise
country: United States
facility: St. Luke's Children's Hospital
state: Idaho
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Orthopaedic Alliance
state: Tennessee
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Boston Children's Hospital
name: Benton Heyworth, M.D.
role: PRINCIPAL_INVESTIGATOR
References: