Anterior Cruciate Ligament InjuriesNCT03954925
Anatomic Anterior Cruciate Ligament With Short Hamstring Graft Compare With a Standard Hamstring Graft Technique
A study testing Anatomic anterior cruciate ligament with short hamstring graft technique and Anatomic anterior cruciate ligament with a standard hamstring graft technique in people with Anterior Cruciate Ligament Injuries, run by Ramathibodi Hospital.
Trial summary
this study was to evaluate the functional outcome of quadruple hamstring graft in femoral tunnel less than 15 mm and morethan or equal 15 mm of ACL reconstruction. The hypothesize that no difference intermediate follow up ( 6 month - 24 month) of functional outcome and clinical evaluation between short and normal… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Anatomic anterior cruciate ligament with short hamstring graft technique and Anatomic anterior cruciate ligament with a standard hamstring graft technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2014to 1 Mar 2019
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with anterior cruciate ligamentous injury with the diagnosis of injured ligaments was made based on a detailed history of the knee injury, physical examination on pathologic status and abnormal laxity, routinely performed plain radiographs and MRI scans, and the findings at surgery.
- Patients who have closed growth plates.
- Patients who younger than 60 years old.
- Patients who absence of ligament injury to the opposite knee.
Who cannot join
- Patients with a combined ligament injury as folling:
- Posterior cruciate ligament
- The lateral collateral ligament
- The posterolateral corner structures of the knee
- Medial collateral ligament.
About this study
Official title: Anatomic Anterior Cruciate Ligament With Short Hamstring Graft Compare With a Standard Hamstring Graft Technique: Prospective Cohort Study
this study was to evaluate the functional outcome of quadruple hamstring graft in femoral tunnel less than 15 mm and morethan or equal 15 mm of ACL reconstruction. The hypothesize that no difference intermediate follow up ( 6 month - 24 month) of functional outcome and clinical evaluation between short and normal femoral tunnel graft length of hamstring tendon ACL reconstruction.
Read the detailed description
The patient recruitment (N=29) and baseline data collection were done at our institute between March2014-September 2015. The inclusion criteria were patients with anterior cruciate ligamentous injury who needed ligamentous reconstruction, closed growth plates and younger than 60 years old, absence of ligament injury to the opposite knee. The exclusion criteria are patients who did not want to participate in this study or patient with failed anterior cruciate ligamentous reconstruction.
All the procedure of anterior cruciate ligament reconstructions were performed by the senior authors (B.C). Semitendinosus and gracilis tendons were harvested through an oblique approach medial to the tibial tubercle in all patients. Complete anterior cruciate ligament was confirmed at arthroscopy. Associated intra-articular injuries such as meniscus tear and cartilage lesions were fixed at of the index operation .The femoral tunnel were drilled though the AM portal.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Anatomic anterior cruciate ligament with short hamstring graft technique, Anatomic anterior cruciate ligament with a standard hamstring graft technique
- Keywords
- ACL, short hamstring graft, standard hamstring graft
- 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.
Anatomic anterior cruciate ligament with short hamstring graft techniqueProcedure or surgery
ACL and short hamstring graft
Anatomic anterior cruciate ligament with a standard hamstring graft techniqueProcedure or surgery
ACL with standard hamstring graft
| Study group | Role | What they receive |
|---|---|---|
| Anatomic anterior cruciate ligament with short hamstring | Active comparator | Anatomic anterior cruciate ligament with short hamstring graft Receives: Procedure: Anatomic anterior cruciate ligament with short hamstring graft technique |
| Anatomic anterior cruciate ligament with standard hamstring | Active comparator | Anatomic anterior cruciate ligament with standard hamstring graft Receives: Procedure: Anatomic anterior cruciate ligament with a standard hamstring graft technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog score
visual analog score rang from 0-10 (minimum=0, maximun=10) and the higher values represent a worse outcome?)
Measured: 18 months
Secondary outcomes (2)
range of motion
range of motion range from 0-160 degree and the higher values represent a better outcome
Measured: 18 months
complication
number of participant who have infection, stiffness and re-operation
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start1 Mar 2014
- Primary completion1 Sep 2015
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Thammasat University
- Responsible party
- Principal investigator, Jatupon Kongtharvonskul, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954925
- Sponsor's protocol ID
- MTU-EC-OT-0-255-61
- Status last verified
- Jun 2019
- First submitted
- 13 May 2019
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomic Anterior Cruciate Ligament With Short Hamstring Graft Compare With a Standard Hamstring Graft Technique: Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03954925
- Acronym / sponsor ID
- MTU-EC-OT-0-255-61
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- ACL, short hamstring graft, standard hamstring graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Collaborators
- Thammasat University
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 1 Sep 2015 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 17 May 2019 (actual)
- 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.
this study was to evaluate the functional outcome of quadruple hamstring graft in femoral tunnel less than 15 mm and morethan or equal 15 mm of ACL reconstruction. The hypothesize that no difference intermediate follow up ( 6 month - 24 month) of functional outcome and clinical evaluation between short and normal femoral tunnel graft length of hamstring tendon ACL reconstruction.
Detailed description
The patient recruitment (N=29) and baseline data collection were done at our institute between March2014-September 2015. The inclusion criteria were patients with anterior cruciate ligamentous injury who needed ligamentous reconstruction, closed growth plates and younger than 60 years old, absence of ligament injury to the opposite knee. The exclusion criteria are patients who did not want to participate in this study or patient with failed anterior cruciate ligamentous reconstruction.
All the procedure of anterior cruciate ligament reconstructions were performed by the senior authors (B.C). Semitendinosus and gracilis tendons were harvested through an oblique approach medial to the tibial tubercle in all patients. Complete anterior cruciate ligament was confirmed at arthroscopy. Associated intra-articular injuries such as meniscus tear and cartilage lesions were fixed at of the index operation .The femoral tunnel were drilled though the AM portal.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anatomic anterior cruciate ligament with short hamstring | Active comparator | Procedure: Anatomic anterior cruciate ligament with short hamstring graft techniqueAnatomic anterior cruciate ligament with short hamstring graft |
| Anatomic anterior cruciate ligament with standard hamstring | Active comparator | Procedure: Anatomic anterior cruciate ligament with a standard hamstring graft techniqueAnatomic anterior cruciate ligament with standard hamstring graft |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with anterior cruciate ligamentous injury with the diagnosis of injured ligaments was made based on a detailed history of the knee injury, physical examination on pathologic status and abnormal laxity, routinely performed plain radiographs and MRI scans, and the findings at surgery.
- Patients who have closed growth plates.
- Patients who younger than 60 years old.
- Patients who absence of ligament injury to the opposite knee.
Key exclusion criteria (5 listed)
- Patients with a combined ligament injury as folling:
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 |
|---|---|---|
| Anatomic anterior cruciate ligament with short hamstring graft techniqueACL and short hamstring graft | Procedure or surgery | Anatomic anterior cruciate ligament with short hamstring |
| Anatomic anterior cruciate ligament with a standard hamstring graft techniqueACL with standard hamstring graft | Procedure or surgery | Anatomic anterior cruciate ligament with standard hamstring |
Primary outcome
Visual analog score
Time frame: 18 months
visual analog score rang from 0-10 (minimum=0, maximun=10) and the higher values represent a worse outcome?)
2 secondary outcomes
range of motion
Time frame: 18 months
complication
Time frame: 18 months
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 20 Jun 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Anatomic anterior cruciate ligament with short hamstring graft technique and Anatomic anterior cruciate ligament with a standard hamstring graft technique in people with Anterior Cruciate Ligament Injuries, run by Ramathibodi 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 4 inclusion and 5 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 20 Jun 2019. 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?
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?
Visual analog score (time frame: 18 months). 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 20 Jun 2019.