Juvenile Osteochondritis DissecansNCT01754298
Study of Two Surgical Drilling Techniques to Treat Juvenile Osteochondritis Dissecans of the Knee
A study testing Retro-articular drilling and Trans-articular drilling in people with Juvenile Osteochondritis Dissecans, run by Boston Children's Hospital at 14 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Juvenile Osteochondritis Dissecans
- What is being tested?
- Retro-articular drilling and Trans-articular drilling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 18 Jan 2013to 16 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States13 sites
St. Luke's Children's Hospital
Boise, Idaho, 83702
Boston Children's Hospital
Boston, Massachusetts, 02115
Rocky Mountain Hospital for Children
Centennial, Colorado, 80112
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Connecticut Children's Medical Center
Farmington, Connecticut, 06032
Kaiser Permanente Los Angeles
Los Angeles, California, 90027
Medical College of Wisconsin
Milwaukee, Wisconsin, 53201
Tennessee Orthopaedic Alliance
Nashville, Tennessee, 37205
Hospital for Special Surgery
New York, New York, 10021
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Rady Children's Hospital
San Diego, California, 92123
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Retro Versus Trans Articular Drilling for Juvenile Osteochondritis Dissecans of the Knee: A Multicenter, Randomized Controlled Trial
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.
- Conditions
- Juvenile Osteochondritis Dissecans
- Being tested
- Retro-articular drilling, Trans-articular drilling
- Keywords
- osteochondritis dissecans (OCD), juvenile osteochondritis dissecans (JOCD), knee osteochondritis dissecans, retro-articular drilling, trans-articular drilling, stable osteochondritis dissecans lesion
- Medical subject headings
- Osteochondritis Dissecans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retro-articular drillingProcedure or surgery
Also called antero-grade, extra-articular
- 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 drillingProcedure or surgery
Also called antero-grade, extra-articular
- 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
| Study group | Role | What they receive |
|---|---|---|
| Retro-articular drilling | Active comparator | Retro-articular drilling goes through the cortical margin of the affected condyle, thereby sparing the articular surface and physes. Receives: Procedure: Retro-articular drilling |
| Trans-articular drilling | Active comparator | Trans-articular drilling penetrates the articular cartilage through multiple sites to create subchondral penetrations. Receives: Procedure: Trans-articular drilling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical functioning measured by the Pedi-IKDC (International Knee Documentation Committee) total score
Measured: One year post-surgery
Secondary outcomes (3)
Activity level as measured by the Marx Activity Scale
Measured: One year post-surgery
Physical functioning as measured by the Pedi-IKDC total score
Measured: Two years post-surgery
Time to lesion healing
Lesion healing will be assessed by x-ray at multiple time points
Measured: 3 months to 2 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study start18 Jan 2013
- Primary completion29 Jul 2019
- Study completion16 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Juvenile Osteochondritis DissecansStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Benton Heyworth, Boston Children's Hospital
- Investigators
- Benton Heyworth, M.D., Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754298
- Sponsor's protocol ID
- IRB-P00004016
- Status last verified
- Dec 2020
- First submitted
- 16 Dec 2012
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37039536
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retro Versus Trans Articular Drilling for Juvenile Osteochondritis Dissecans of the Knee: A Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01754298
- Acronym / sponsor ID
- IRB-P00004016
- Conditions
- Juvenile Osteochondritis Dissecans
- Keywords
- osteochondritis dissecans (OCD), juvenile osteochondritis dissecans (JOCD), knee osteochondritis dissecans, retro-articular drilling, trans-articular drilling, stable osteochondritis dissecans lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- 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
- Study start
- 18 Jan 2013 (actual)
- Primary completion
- 29 Jul 2019 (actual)
- Study completion
- 16 Oct 2020 (actual)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retro-articular drilling | Active comparator | Procedure: Retro-articular drillingRetro-articular drilling goes through the cortical margin of the affected condyle, thereby sparing the articular surface and physes. |
| Trans-articular drilling | Active comparator | Procedure: Trans-articular drillingTrans-articular drilling penetrates the articular cartilage through multiple sites to create subchondral penetrations. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retro-articular drillingAlso: antero-grade, extra-articular* 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. | Procedure or surgery | Retro-articular drilling |
| Trans-articular drillingAlso: antero-grade, extra-articular* 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 | Procedure or surgery | Trans-articular drilling |
Primary outcome
Physical functioning measured by the Pedi-IKDC (International Knee Documentation Committee) total score
Time frame: One year post-surgery
3 secondary outcomes
Activity level as measured by the Marx Activity Scale
Time frame: One year post-surgery
Physical functioning as measured by the Pedi-IKDC total score
Time frame: Two years post-surgery
Time to lesion healing
Time frame: 3 months to 2 years post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Derived from this study: PubMed 37039536Heyworth 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.
- Research in OsteoChondritis of the Knee, OCD Study Group of North AmericaLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benton Heyworth, M.D. principal investigator
Boston Children's Hospital
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retro-articular drilling and Trans-articular drilling in people with Juvenile Osteochondritis Dissecans, run by Boston Children's Hospital at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical functioning measured by the Pedi-IKDC (International Knee Documentation Committee) total score (time frame: One year post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01754298, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.