Trial record 18 of 19 for:
Open Studies | "Cartilage Diseases"
Study of Two Surgical Drilling Techniques to Treat Juvenile Osteochondritis Dissecans of the Knee
This study is currently recruiting participants.
Verified December 2012 by Children's Hospital Boston
Sponsor:
Children's Hospital Boston
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: December 18, 2012
Last verified: December 2012
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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 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 2015 |
| Estimated Primary Completion Date: | November 2014 (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
Other Names:
|
|
Active Comparator: Trans-articular drilling
Trans-articular drilling penetrates the articular cartilage through multiple sites to create subchondral penetrations.
|
Procedure: Trans-articular drilling
Other Names:
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01754298
Contacts
| Contact: Catherine Suppan, B.A. | 857-218-3272 | catherine.suppan@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 | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Annamarie Horan Annamarie.Horan@uphs.upenn.edu | |
| Principal Investigator: James L. Carey, MD | |
| 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 | |
| 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: | December 18, 2012 |
| 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 |
Musculoskeletal Diseases Cartilage Diseases Connective Tissue Diseases |
ClinicalTrials.gov processed this record on May 16, 2013