Trial record 2 of 14 for:    "Osteochondritis dissecans"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Children's Hospital Boston
Sponsor:
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
Information provided by (Responsible Party):
Benton Heyworth, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01754298
First received: December 16, 2012
Last updated: September 29, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Juvenile Osteochondritis Dissecans
Procedure: Retro-articular drilling
Procedure: Trans-articular drilling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Retro Versus Trans Articular Drilling for Juvenile Osteochondritis Dissecans of the Knee: A Multicenter, Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Physical functioning measured by the Pedi-IKDC (International Knee Documentation Committee) total score [ Time Frame: One year post-surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Activity level as measured by the Marx Activity Scale [ Time Frame: One year post-surgery ] [ Designated as safety issue: No ]
  • Physical functioning as measured by the Pedi-IKDC total score [ Time Frame: Two years post-surgery ] [ Designated as safety issue: No ]
  • Time to lesion healing [ Time Frame: 3 months to 2 years post-surgery ] [ Designated as safety issue: No ]
    Lesion healing will be assessed by x-ray at multiple time points


Other Outcome Measures:
  • Surgical complications [ Time Frame: 1 week to 1 year post-surgery ] [ Designated as safety issue: Yes ]
    Inadvertent displacement of OCD fragment; damage to articular cartilage and physes


Estimated Enrollment: 58
Study Start Date: November 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Retro-articular drilling
Retro-articular drilling goes through the cortical margin of the affected condyle, thereby sparing the articular surface and physes.
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.
Other Names:
  • antero-grade
  • extra-articular
Active Comparator: Trans-articular drilling
Trans-articular drilling penetrates the articular cartilage through multiple sites to create subchondral penetrations.
Procedure: 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
Other Names:
  • antero-grade
  • extra-articular

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • 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,
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754298

Contacts
Contact: Kyna Donohue, B.A. 857-218-3272 kyna.donohue@childrens.harvard.edu

Locations
United States, California
Kaiser Permanente Los Angeles Not yet recruiting
Los Angeles, California, United States, 90027
Contact: Jennifer M. Weiss, MD    310-597-9216    jennifermweiss@yahoo.com   
Principal Investigator: Jennifer M. Weiss, MD         
Rady Children's Hospital Recruiting
San Diego, California, United States, 92123
Contact: Joanna Roocroft       jroocroft@rchsd.org   
Principal Investigator: Henry G. Chambers, MD         
United States, Colorado
Rocky Mountain Hospital for Children Not yet recruiting
Centennial, Colorado, United States, 80112
Contact: John D Polousky, MD    720-979-0840    johnpolousky@msn.com   
Principal Investigator: John D. Polousky, MD         
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Farmington, Connecticut, United States, 06032
Contact: Emily O'Hara       eohara@hartford.edu   
Principal Investigator: Carl W. Nissen, MD         
United States, Idaho
St. Luke's Children's Hospital Recruiting
Boise, Idaho, United States, 83702
Contact: Jake Jacobs       jacobsjo@slhs.org   
Principal Investigator: Kevin G Shea, MD         
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Catherine Suppan, BA    857-218-3272    catherine.suppan@childrens.harvard.edu   
Principal Investigator: Benton Heyworth, MD         
United States, Missouri
Washington University School of Medicine Not yet recruiting
St. Louis, Missouri, United States, 63110
Contact: Amanda Haas       haasa@wudosis.wustl.edu   
Principal Investigator: Rick W. Wright, MD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Emily Eismann       Emily.Eismann@cchmc.org   
Principal Investigator: Eric J. Wall, MD         
United States, Pennsylvania
The Children's Hopstial of Philadelphia Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Melissa Gunderson       GundersonM@email.chop.edu   
Principal Investigator: Theodore J. Ganley, MD         
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Annamarie Horan       Annamarie.Horan@uphs.upenn.edu   
Principal Investigator: James L. Carey, MD         
United States, Tennessee
Tennessee Orthopaedic Alliance Recruiting
Nashville, Tennessee, United States, 37205
Contact: Kimberly Owens       kimberly.owens@stthomas.org   
Principal Investigator: Allen F. Anderson, MD         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53201
Contact: Jeff Crawford       jcrawford@chw.org   
Principal Investigator: Roger M. Lyon, MD         
Canada, Ontario
The Hospital for Sick Children Not yet recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: M. Lucas Murnaghan, MD    (416) 823-4902    lucas.murnaghan@sickkids.ca   
Principal Investigator: M. Lucas Murnaghan, MD         
Sponsors and Collaborators
Children's Hospital Boston
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
Investigators
Principal Investigator: Benton Heyworth, M.D. Children's Hospital Boston
  More Information

Additional Information:
No publications provided

Responsible Party: Benton Heyworth, Instructor in Orthopaedic Surgery, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01754298     History of Changes
Other Study ID Numbers: IRB-P00004016
Study First Received: December 16, 2012
Last Updated: September 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
osteochondritis dissecans (OCD)
juvenile osteochondritis dissecans (JOCD)
knee osteochondritis dissecans
retro-articular drilling
trans-articular drilling
stable osteochondritis dissecans lesion

Additional relevant MeSH terms:
Osteochondritis
Osteochondritis Dissecans
Osteochondrosis
Bone Diseases
Cartilage Diseases
Connective Tissue Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 23, 2014