Study of Two Surgical Drilling Techniques to Treat Juvenile Osteochondritis Dissecans of the Knee
Retro Versus Trans Articular Drilling for Juvenile Osteochondritis Dissecans of the Knee: A Multicenter, Randomized Controlled Trial
1 other identifier
interventional
91
2 countries
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2013
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2012
CompletedFirst Posted
Study publicly available on registry
December 21, 2012
CompletedStudy Start
First participant enrolled
January 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 16, 2020
CompletedDecember 3, 2020
December 1, 2020
6.5 years
December 16, 2012
December 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Physical functioning measured by the Pedi-IKDC (International Knee Documentation Committee) total score
One year post-surgery
Secondary Outcomes (3)
Activity level as measured by the Marx Activity Scale
One year post-surgery
Physical functioning as measured by the Pedi-IKDC total score
Two years post-surgery
Time to lesion healing
3 months to 2 years post-surgery
Other Outcomes (1)
Surgical complications
1 week to 1 year post-surgery
Study Arms (2)
Retro-articular drilling
ACTIVE COMPARATORRetro-articular drilling goes through the cortical margin of the affected condyle, thereby sparing the articular surface and physes.
Trans-articular drilling
ACTIVE COMPARATORTrans-articular drilling penetrates the articular cartilage through multiple sites to create subchondral penetrations.
Interventions
* 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.
* 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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Children's Hospitallead
- Pediatric Orthopaedic Society of North Americacollaborator
- University of Pennsylvaniacollaborator
- Tennessee Orthopedic Alliancecollaborator
- Children's Hospital Medical Center, Cincinnaticollaborator
- Children's Hospital and Health System Foundation, Wisconsincollaborator
- Washington University School of Medicinecollaborator
- The Hospital for Sick Childrencollaborator
- Children's Hospital of Philadelphiacollaborator
- Kaiser Permanentecollaborator
- Rady Children's Hospital, San Diegocollaborator
- St. Luke's Children's Hospitalcollaborator
- Medical College of Wisconsincollaborator
- Connecticut Children's Medical Centercollaborator
- Hospital for Special Surgery, New Yorkcollaborator
Study Sites (14)
Kaiser Permanente Los Angeles
Los Angeles, California, 90027, United States
Rady Children's Hospital
San Diego, California, 92123, United States
Rocky Mountain Hospital for Children
Centennial, Colorado, 80112, United States
Connecticut Children's Medical Center
Farmington, Connecticut, 06032, United States
St. Luke's Children's Hospital
Boise, Idaho, 83702, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Tennessee Orthopaedic Alliance
Nashville, Tennessee, 37205, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53201, United States
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Related Publications (1)
Heyworth BE, Ganley TJ, Liotta ES, Hergott KA, Miller PE, Wall EJ, Myer GD, Nissen CW, Edmonds EW, Lyon RM, Chambers HG, Milewski MD, Green DW, Weiss JM, Wright RW, Polousky JD, Nepple JJ, Carey JL, Kocher MS; ROCK Group; Shea KG. Transarticular Versus Retroarticular Drilling of Stable Osteochondritis Dissecans of the Knee: A Prospective Multicenter Randomized Controlled Trial by the ROCK Group. Am J Sports Med. 2023 May;51(6):1392-1402. doi: 10.1177/03635465231165290. Epub 2023 Apr 11.
PMID: 37039536DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benton Heyworth, M.D.
Boston Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Instructor in Orthopaedic Surgery
Study Record Dates
First Submitted
December 16, 2012
First Posted
December 21, 2012
Study Start
January 18, 2013
Primary Completion
July 29, 2019
Study Completion
October 16, 2020
Last Updated
December 3, 2020
Record last verified: 2020-12