Rupture of Anterior Cruciate LigamentNCT02833454
Study of the Anatomical Direct Insertion Anterior Cruciate Ligament Reconstruction
A study testing direct insertion anterior cruciate ligament reconstruction, single bundle anterior cruciate ligament reconstruction and double bundle anterior cruciate ligament reconstruction in people with Rupture of Anterior Cruciate Ligament, run by Peking University Third Hospital.
Trial summary
The purpose of the study is to study the effect of anatomical direct insertion ACL reconstruction compared with conventional anatomical ACL reconstruction. Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Rupture of Anterior Cruciate Ligament
- What is being tested?
- direct insertion anterior cruciate ligament reconstruction, single bundle anterior cruciate ligament reconstruction and double bundle anterior cruciate ligament reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Aug 2018
- 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 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ACL rupture patients aged between 16 to 40 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 infammatory 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: Anterior Cruciate Ligament Reconstruction (ACLR) Using Direct Insertion Technique or Traditional Technique With Single and Double Bundle Procedure.
The purpose of the study is to study the effect of anatomical direct insertion ACL reconstruction compared with conventional anatomical ACL reconstruction.
Read the detailed description
The investigators divide 320 patients with ACL rupture into 4 groups, each group has 80 patients. The operation technique is different among the groups: group A: conventional anatomical double bundle acl reconstruction, group B: conventional anatomical single bundle acl reconstruction, group DA: direct insertion double bundle acl reconstruction, group DSB: direct insertion single bundle acl reconstruction. The investigators compare the results of the patients of each group at 2 years of surgery.
- Conditions
- Rupture of Anterior Cruciate Ligament
- Being tested
- direct insertion anterior cruciate ligament reconstruction, single bundle anterior cruciate ligament reconstruction, double bundle anterior cruciate ligament reconstruction
- Keywords
- Anterior Cruciate Ligament Reconstruction, Direct Insertion of Anterior Cruciate Ligament
- 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.
direct insertion anterior cruciate ligament reconstructionProcedure or surgery
ACL reconstruction based on direct insertion of ACL.
single bundle anterior cruciate ligament reconstructionProcedure or surgery
anterior cruciate ligament reconstruction using single bundle technique
double bundle anterior cruciate ligament reconstructionProcedure or surgery
anterior cruciate ligament reconstruction using double bundle technique
| Study group | Role | What they receive |
|---|---|---|
| direct insertion single bundle ACLR | Active comparator | Patients with ACL rupture undergo direct insertion anterior cruciate ligament reconstruction using single bundle technique. Receives: Procedure: direct insertion anterior cruciate ligament reconstruction; Procedure: single bundle anterior cruciate ligament reconstruction |
| anatomical double bundle ACLR | Experimental | Patients with ACL rupture undergo double bundle anterior cruciate ligament reconstruction. Receives: Procedure: double bundle anterior cruciate ligament reconstruction |
| anatomical single bundle ACLR | Experimental | Patients with ACL rupture undergo single bundle anterior cruciate ligament reconstruction. Receives: Procedure: single bundle anterior cruciate ligament reconstruction |
| direct insertion double bundle ACLR | Active comparator | Patients with ACL rupture undergo direct insertion anterior cruciate ligament reconstruction using double bundle technique. Receives: Procedure: direct insertion anterior cruciate ligament reconstruction; Procedure: double bundle anterior cruciate ligament reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lysholm score of the knee
Lysholm score of the knee was evaluated preoperatively and at 2 years post operation .
Scale name:score
Measured: two years
Tegner score of the knee
Tegner score of the knee was evaluated preoperatively and at 2 years post operation .
Scale name:score
Measured: two years
IKDC score of the knee
IKDC score of the knee was evaluated preoperatively and at 2 years post operation .
Scale name:score
Measured: two years
Secondary outcomes (1)
KT-2000 of the knee
KT-2000 of the knee was evaluated preoperatively and at 2 years post operation.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2018 (estimated)
- Study completionAug 2018 (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.
- More trials run by Peking University Third 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 320 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, MD, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833454
- Sponsor's protocol ID
- DACL-1
- Status last verified
- Jul 2016
- First submitted
- 11 Jul 2016
- Last updated
- 15 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Cruciate Ligament Reconstruction (ACLR) Using Direct Insertion Technique or Traditional Technique With Single and Double Bundle Procedure.
- ClinicalTrials.gov ID
- NCT02833454
- Acronym / sponsor ID
- DACL-1
- Conditions
- Rupture of Anterior Cruciate Ligament
- Keywords
- Anterior Cruciate Ligament Reconstruction, Direct Insertion of Anterior Cruciate Ligament
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 14 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.
The purpose of the study is to study the effect of anatomical direct insertion ACL reconstruction compared with conventional anatomical ACL reconstruction.
Detailed description
The investigators divide 320 patients with ACL rupture into 4 groups, each group has 80 patients. The operation technique is different among the groups: group A: conventional anatomical double bundle acl reconstruction, group B: conventional anatomical single bundle acl reconstruction, group DA: direct insertion double bundle acl reconstruction, group DSB: direct insertion single bundle acl reconstruction. The investigators compare the results of the patients of each group at 2 years of surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| direct insertion single bundle ACLR | Active comparator | Procedure: direct insertion anterior cruciate ligament reconstruction, Procedure: single bundle anterior cruciate ligament reconstructionPatients with ACL rupture undergo direct insertion anterior cruciate ligament reconstruction using single bundle technique. |
| anatomical double bundle ACLR | Experimental | Procedure: double bundle anterior cruciate ligament reconstructionPatients with ACL rupture undergo double bundle anterior cruciate ligament reconstruction. |
| anatomical single bundle ACLR | Experimental | Procedure: single bundle anterior cruciate ligament reconstructionPatients with ACL rupture undergo single bundle anterior cruciate ligament reconstruction. |
| direct insertion double bundle ACLR | Active comparator | Procedure: direct insertion anterior cruciate ligament reconstruction, Procedure: double bundle anterior cruciate ligament reconstructionPatients with ACL rupture undergo direct insertion anterior cruciate ligament reconstruction using double bundle technique. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- ACL rupture patients aged between 16 to 40 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 infammatory 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 |
|---|---|---|
| direct insertion anterior cruciate ligament reconstructionACL reconstruction based on direct insertion of ACL. | Procedure or surgery | direct insertion double bundle ACLR, direct insertion single bundle ACLR |
| single bundle anterior cruciate ligament reconstructionanterior cruciate ligament reconstruction using single bundle technique | Procedure or surgery | anatomical single bundle ACLR, direct insertion single bundle ACLR |
| double bundle anterior cruciate ligament reconstructionanterior cruciate ligament reconstruction using double bundle technique | Procedure or surgery | anatomical double bundle ACLR, direct insertion double bundle ACLR |
Primary outcome
Lysholm score of the knee
Time frame: two years
Lysholm score of the knee was evaluated preoperatively and at 2 years post operation . Scale name:score
Tegner score of the knee
Time frame: two years
Tegner score of the knee was evaluated preoperatively and at 2 years post operation . Scale name:score
IKDC score of the knee
Time frame: two years
IKDC score of the knee was evaluated preoperatively and at 2 years post operation . Scale name:score
1 secondary outcome
KT-2000 of the knee
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 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, MD study chair
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
A study testing direct insertion anterior cruciate ligament reconstruction, single bundle anterior cruciate ligament reconstruction and double bundle anterior cruciate ligament 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 15 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?
Lysholm score of the knee (time frame: two years). The study lists 3 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 15 Jul 2016.