BridgeMD
New treatment option for ACL - Anterior Cruciate Ligament Rupture
Official title Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings
ClinicalTrials.gov ID: NCT03896464
What this study is testing
- What it's testing
- To date, the use of the quadriceps tendon as an autograft option in primary paediatric Anterior Cruciate Ligament (ACL) reconstruction has not been well studied. The 2018 International Olympic Committee (IOC) Consensus Statement now outlines the quadriceps tendon as a possible autograft option.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 18
You may be able to join if
- Patients aged 10-18 years.
- History, physical exam, and magnetic resonance imaging (MRI) or arthroscopic image confirmation of ACL insufficiency.
- Suitable for anatomic, single-bundle arthroscopic-assisted ACL reconstruction.
- X-ray or MRI evidence of skeletal immaturity (i.e., open physes) based on imaging that is closest to the time of injury (and correlated with standard...
- Patient involved in sport (competitive and/or recreational level) prior to injury.
You likely can't join if
- Evidence (i.e. radiographic and/or arthroscopic) of International Cartilage Repair Society (ICRS) Cartilage Lesion Classification System Grade 2...
- Tibial eminence/spine fractures treated surgically.
- Concomitant collateral, posterior cruciate, and/or cartilage pathology requiring surgical reconstruction and/or advanced restoration techniques...
- Previous ACL reconstruction in the affected knee or contralateral knee.
- Previous distal femur and/or proximal tibial/fibular physeal injury in the affected knee or contralateral knee.
- Allograft or allograft-augmentation, or synthetic augmentation of the ACL reconstruction.
See the full eligibility criteria
- Patients aged 10-18 years.
- History, physical exam, and magnetic resonance imaging (MRI) or arthroscopic image confirmation of ACL insufficiency.
- Suitable for anatomic, single-bundle arthroscopic-assisted ACL reconstruction.
- X-ray or MRI evidence of skeletal immaturity (i.e., open physes) based on imaging that is closest to the time of injury (and correlated with standard bone age left hand posteroanterior (PA) radiographs).
- Patient involved in sport (competitive and/or recreational level) prior to injury.
- Patient and parent/guardian speak, read, and understand the language of the clinical site.
- Patient and parent/guardian provide informed consent and/or assent.
- Evidence (i.e. radiographic and/or arthroscopic) of International Cartilage Repair Society (ICRS) Cartilage Lesion Classification System Grade 2 (i.e., lesions extending down to 50% of the cartilage depth) and higher...
- Tibial eminence/spine fractures treated surgically.
- Concomitant collateral, posterior cruciate, and/or cartilage pathology requiring surgical reconstruction and/or advanced restoration techniques (i.e., osteochondral allograft or autograft transfer, matrix-induced...
- Previous ACL reconstruction in the affected knee or contralateral knee.
- Previous distal femur and/or proximal tibial/fibular physeal injury in the affected knee or contralateral knee.
- Allograft or allograft-augmentation, or synthetic augmentation of the ACL reconstruction.
- Biological-augmentation of the ACL reconstruction (i.e. platelet-rich-plasma, fibrin clot, reinforced bioinductive implants, etc.).
- ACL reconstruction utilizing synthetic grafts.
- Primary ACL repair.
- Patient diagnosed with inflammatory arthropathy.
- Significant medical co-morbidities (requiring daily assistance for activities of daily living).
- Patient, parent/guardian, and/or clinical investigator believe the patient will have difficulty maintaining follow-up.
The study team makes the final eligibility decision.
Where it's taking place
- Hamilton, Ontario, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Kobe, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamilton, Ontario, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Kobe, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.