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

Primary Purpose

Juvenile Osteochondritis Dissecans

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Retro-articular drilling
Trans-articular drilling
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Osteochondritis Dissecans focused on measuring osteochondritis dissecans (OCD), juvenile osteochondritis dissecans (JOCD), knee osteochondritis dissecans, retro-articular drilling, trans-articular drilling, stable osteochondritis dissecans lesion

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • Kaiser Permanente Los Angeles
  • Rady Children's Hospital
  • Rocky Mountain Hospital for Children
  • Connecticut Children's Medical Center
  • St. Luke's Children's Hospital
  • Boston Children's Hospital
  • Washington University School of Medicine
  • Hospital for Special Surgery
  • Cincinnati Children's Hospital Medical Center
  • Children's Hospital of Philadelphia
  • University of Pennsylvania
  • Tennessee Orthopaedic Alliance
  • Medical College of Wisconsin
  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Retro-articular drilling

Trans-articular drilling

Arm Description

Retro-articular drilling goes through the cortical margin of the affected condyle, thereby sparing the articular surface and physes.

Trans-articular drilling penetrates the articular cartilage through multiple sites to create subchondral penetrations.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Activity level as measured by the Marx Activity Scale
Physical functioning as measured by the Pedi-IKDC total score
Time to lesion healing
Lesion healing will be assessed by x-ray at multiple time points

Full Information

First Posted
December 16, 2012
Last Updated
December 2, 2020
Sponsor
Boston Children's Hospital
Collaborators
Pediatric Orthopaedic Society of North America, University of Pennsylvania, Tennessee Orthopedic Alliance, Children's Hospital Medical Center, Cincinnati, Children's Hospital and Health System Foundation, Wisconsin, Washington University School of Medicine, The Hospital for Sick Children, Children's Hospital of Philadelphia, Kaiser Permanente, Rady Children's Hospital, San Diego, St. Luke's Children's Hospital, Medical College of Wisconsin, Connecticut Children's Medical Center, Hospital for Special Surgery, New York
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1. Study Identification

Unique Protocol Identification Number
NCT01754298
Brief Title
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

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 18, 2013 (Actual)
Primary Completion Date
July 29, 2019 (Actual)
Study Completion Date
October 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
Pediatric Orthopaedic Society of North America, University of Pennsylvania, Tennessee Orthopedic Alliance, Children's Hospital Medical Center, Cincinnati, Children's Hospital and Health System Foundation, Wisconsin, Washington University School of Medicine, The Hospital for Sick Children, Children's Hospital of Philadelphia, Kaiser Permanente, Rady Children's Hospital, San Diego, St. Luke's Children's Hospital, Medical College of Wisconsin, Connecticut Children's Medical Center, Hospital for Special Surgery, New York

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Osteochondritis Dissecans
Keywords
osteochondritis dissecans (OCD), juvenile osteochondritis dissecans (JOCD), knee osteochondritis dissecans, retro-articular drilling, trans-articular drilling, stable osteochondritis dissecans lesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Retro-articular drilling
Arm Type
Active Comparator
Arm Description
Retro-articular drilling goes through the cortical margin of the affected condyle, thereby sparing the articular surface and physes.
Arm Title
Trans-articular drilling
Arm Type
Active Comparator
Arm Description
Trans-articular drilling penetrates the articular cartilage through multiple sites to create subchondral penetrations.
Intervention Type
Procedure
Intervention Name(s)
Retro-articular drilling
Other Intervention Name(s)
antero-grade, extra-articular
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Trans-articular drilling
Other Intervention Name(s)
antero-grade, extra-articular
Intervention Description
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
Primary Outcome Measure Information:
Title
Physical functioning measured by the Pedi-IKDC (International Knee Documentation Committee) total score
Time Frame
One year post-surgery
Secondary Outcome Measure Information:
Title
Activity level as measured by the Marx Activity Scale
Time Frame
One year post-surgery
Title
Physical functioning as measured by the Pedi-IKDC total score
Time Frame
Two years post-surgery
Title
Time to lesion healing
Description
Lesion healing will be assessed by x-ray at multiple time points
Time Frame
3 months to 2 years post-surgery
Other Pre-specified Outcome Measures:
Title
Surgical complications
Description
Inadvertent displacement of OCD fragment; damage to articular cartilage and physes
Time Frame
1 week to 1 year post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benton Heyworth, M.D.
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Rady Children's Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Rocky Mountain Hospital for Children
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Connecticut Children's Medical Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
St. Luke's Children's Hospital
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Tennessee Orthopaedic Alliance
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53201
Country
United States
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Links:
URL
https://kneeocd.org//
Description
Research in OsteoChondritis of the Knee, OCD Study Group of North America

Learn more about this trial

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

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