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

NCT ID: NCT01754298

Last Updated: 2020-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-18

Study Completion Date

2020-10-16

Brief Summary

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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.

Detailed Description

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Conditions

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Juvenile Osteochondritis Dissecans

Keywords

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osteochondritis dissecans (OCD) juvenile osteochondritis dissecans (JOCD) knee osteochondritis dissecans retro-articular drilling trans-articular drilling stable osteochondritis dissecans lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Retro-articular drilling

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

Group Type ACTIVE_COMPARATOR

Retro-articular drilling

Intervention Type PROCEDURE

* 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.

Trans-articular drilling

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

Group Type ACTIVE_COMPARATOR

Trans-articular drilling

Intervention Type PROCEDURE

* 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

Interventions

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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.

Intervention Type 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

Intervention Type PROCEDURE

Other Intervention Names

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antero-grade extra-articular antero-grade extra-articular

Eligibility Criteria

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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,
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pediatric Orthopaedic Society of North America

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role collaborator

Tennessee Orthopedic Alliance

OTHER

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role collaborator

Children's Hospital and Health System Foundation, Wisconsin

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role collaborator

The Hospital for Sick Children

OTHER

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role collaborator

Rady Children's Hospital, San Diego

OTHER

Sponsor Role collaborator

St. Luke's Children's Hospital

OTHER

Sponsor Role collaborator

Medical College of Wisconsin

OTHER

Sponsor Role collaborator

Connecticut Children's Medical Center

OTHER

Sponsor Role collaborator

Hospital for Special Surgery, New York

OTHER

Sponsor Role collaborator

Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Benton Heyworth

Instructor in Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Benton Heyworth, M.D.

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Kaiser Permanente Los Angeles

Los Angeles, California, United States

Site Status

Rady Children's Hospital

San Diego, California, United States

Site Status

Rocky Mountain Hospital for Children

Centennial, Colorado, United States

Site Status

Connecticut Children's Medical Center

Farmington, Connecticut, United States

Site Status

St. Luke's Children's Hospital

Boise, Idaho, United States

Site Status

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Hospital for Special Surgery

New York, New York, United States

Site Status

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Tennessee Orthopaedic Alliance

Nashville, Tennessee, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type DERIVED
PMID: 37039536 (View on PubMed)

Related Links

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https://kneeocd.org//

Research in OsteoChondritis of the Knee, OCD Study Group of North America

Other Identifiers

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IRB-P00004016

Identifier Type: -

Identifier Source: org_study_id