Rupture of Anterior Cruciate LigamentNCT02834962
Study of Single And Double Bundle Anterior Cruciate Ligament (ACL) Graft Cross-sectional Dimensions
A study testing single bundle ACL reconstruction and double bundle ACL reconstruction in people with Rupture of Anterior Cruciate Ligament, run by Peking University Third Hospital.
Trial summary
To study the difference between single and double bundle ACL graft cross-sectional dimensions compared with native ACL using postoperative 3-D MRI. Read more about this study
- Who is it for?
- Ages 10 to 50 years
- Conditions the study is for
- Rupture of Anterior Cruciate Ligament
- What is being tested?
- single bundle ACL reconstruction and double bundle ACL reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Aug 2017
- 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 10 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ACL rupture patients aged between 10 to 50 years
Who cannot join
- combined severe injuries to the operated knee (additional ligament rupture, major meniscus loss, patella instability, cartilage damage >2°, pathologic leg axis deviation)
- any injury or surgery to the contralateral knee
- any inflammatory or systemic disease, neuromuscular disease in the lower limbs,any recent knee infection
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study of Single And Double Bundle ACL Graft Cross-sectional Dimensions Compared With Native ACL
To study the difference between single and double bundle ACL graft cross-sectional dimensions compared with native ACL using postoperative 3-D MRI.
Read the detailed description
The investigators divide 100 patients with ACL rupture into 2 groups. Group A undergo single bundle anterior cruciate ligament reconstruction (ACLR). Group B undergo double bundle ACL reconstruction. At 3-6 weeks post operation, all the patients undergo 3-D MRI examination of both knees. The investigators reconstruct 3-D models of reconstructed ACL and native ACL, and compare the difference between single and double bundle graft.
- Conditions
- Rupture of Anterior Cruciate Ligament
- Being tested
- single bundle ACL reconstruction, double bundle ACL reconstruction
- Keywords
- Anterior Cruciate Ligament Reconstruction
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single bundle ACL reconstructionProcedure or surgery
anterior cruciate ligament reconstruction using single bundle technique
double bundle ACL reconstructionProcedure or surgery
anterior cruciate ligament reconstruction using double bundle technique
| Study group | Role | What they receive |
|---|---|---|
| single bundle ACLR | Experimental | patients undergo single bundle ACL reconstruction Receives: Procedure: single bundle ACL reconstruction |
| double bundle ACLR | Active comparator | patients undergo double bundle ACL reconstruction Receives: Procedure: double bundle ACL reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
cross-sectional area of the reconstructed ACL
Measured: 3-6 weeks
long to short axis ratio of the cross-sectional area of the reconstructed ACL
Measured: 3-6 weeks
long axis of the cross-sectional area of the reconstructed ACL
Measured: 3-6 weeks
short axis of the cross-sectional area of the reconstructed ACL
Measured: 3-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rupture of Anterior Cruciate LigamentStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia-kuo yu, Peking University Third Hospital
- Investigators
- Jia-Kuo Yu, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834962
- Sponsor's protocol ID
- ACLMRI-1
- Status last verified
- Jul 2016
- First submitted
- 13 Jul 2016
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Single And Double Bundle ACL Graft Cross-sectional Dimensions Compared With Native ACL
- ClinicalTrials.gov ID
- NCT02834962
- Acronym / sponsor ID
- ACLMRI-1
- Conditions
- Rupture of Anterior Cruciate Ligament
- Keywords
- Anterior Cruciate Ligament Reconstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 15 Jul 2016 (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.
To study the difference between single and double bundle ACL graft cross-sectional dimensions compared with native ACL using postoperative 3-D MRI.
Detailed description
The investigators divide 100 patients with ACL rupture into 2 groups. Group A undergo single bundle anterior cruciate ligament reconstruction (ACLR). Group B undergo double bundle ACL reconstruction. At 3-6 weeks post operation, all the patients undergo 3-D MRI examination of both knees. The investigators reconstruct 3-D models of reconstructed ACL and native ACL, and compare the difference between single and double bundle graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single bundle ACLR | Experimental | Procedure: single bundle ACL reconstructionpatients undergo single bundle ACL reconstruction |
| double bundle ACLR | Active comparator | Procedure: double bundle ACL reconstructionpatients undergo double bundle ACL reconstruction |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- ACL rupture patients aged between 10 to 50 years
Key exclusion criteria (3 listed)
- combined severe injuries to the operated knee (additional ligament rupture, major meniscus loss, patella instability, cartilage damage >2°, pathologic leg axis deviation)
- any injury or surgery to the contralateral knee
- any inflammatory or systemic disease, neuromuscular disease in the lower limbs,any recent knee infection
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 |
|---|---|---|
| single bundle ACL reconstructionanterior cruciate ligament reconstruction using single bundle technique | Procedure or surgery | single bundle ACLR |
| double bundle ACL reconstructionanterior cruciate ligament reconstruction using double bundle technique | Procedure or surgery | double bundle ACLR |
Primary outcome
cross-sectional area of the reconstructed ACL
Time frame: 3-6 weeks
long to short axis ratio of the cross-sectional area of the reconstructed ACL
Time frame: 3-6 weeks
long axis of the cross-sectional area of the reconstructed ACL
Time frame: 3-6 weeks
short axis of the cross-sectional area of the reconstructed ACL
Time frame: 3-6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2016.
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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.
Jia-Kuo Yu study chair
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
A study testing single bundle ACL reconstruction and double bundle ACL reconstruction in people with Rupture of Anterior Cruciate Ligament, run by Peking University Third Hospital.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Jia-Kuo, MD (86-10-82267392, yujiakuo@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cross-sectional area of the reconstructed ACL (time frame: 3-6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2016.