Anterior Cruciate Ligament TearPhase 4NCT01025895
Anterior Cruciate Ligament (ACL) Reconstruction: Single Bundle Versus Double Bundle
A Phase 4 study testing acl reconstruction - double bundle technique and acle reconstruction - single bundle technique in people with Anterior Cruciate Ligament Tear, run by Assaf-Harofeh Medical Center.
Trial summary
ACL tear is a common injury among athletes. The recommended treatment includes reconstruction of the ligament. The common reconstruction technique is single bundle reconstruction. However, this technique does not simulate the natural structure of the ligament. Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament Tear
- What is being tested?
- acl reconstruction - double bundle technique and acle reconstruction - single bundle technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jan 2013
- Phase
- Phase 4
- 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
- knee instability with a history of ACL tear
- diagnosed ACL tear according to MRI
- age range 16-40.
Who cannot join
- previous surgery in the knees
- multiple ligament raptures
- partial ACL tear
- severe cartilage degeneration
- genovaruse/genovalgus
- thin hamstrings tendons
- oper epiphysis in the knee joint
- patient with muscle/neurological problem that increases the tendency to fall
About this study
ACL tear is a common injury among athletes. The recommended treatment includes reconstruction of the ligament. The common reconstruction technique is single bundle reconstruction. However, this technique does not simulate the natural structure of the ligament. The purpose of the study is to compare between the common procedure, Single Bundle reconstruction with the Double Bundle reconstruction technique.
- Conditions
- Anterior Cruciate Ligament Tear
- Being tested
- acl reconstruction - double bundle technique, acle reconstruction - single bundle technique
- Keywords
- arthroscopic surgical procedure
- 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.
acl reconstruction - double bundle techniqueProcedure or surgery
acle reconstruction - single bundle techniqueProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| single bundle | Active comparator | acl reconstruction - single bundle technique Receives: Procedure: acle reconstruction - single bundle technique |
| double bundle | Experimental | acl reconstruction - double bundle technique Receives: Procedure: acl reconstruction - double bundle technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC, VAS, SF-36, Lisholm, Knee society score, isokinetic muscle strength testing, Single HOP test , Tripple Hop Test
Measured: pre-op. 1 day post op., 7-14 days post op., 6 weeks post op., 12 weeks post op., 26 weeks post op., 1 year post op., 2 years post op.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionJan 2011 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament TearStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025895
- Sponsor's protocol ID
- 144/09
- Status last verified
- Jul 2009
- First submitted
- 3 Dec 2009
- Last updated
- 4 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Cruciate Ligament (ACL) Reconstruction: Single Bundle Versus Double Bundle
- ClinicalTrials.gov ID
- NCT01025895
- Acronym / sponsor ID
- 144/09
- Conditions
- Anterior Cruciate Ligament Tear
- Keywords
- arthroscopic surgical procedure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 4 Dec 2009 (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.
ACL tear is a common injury among athletes. The recommended treatment includes reconstruction of the ligament. The common reconstruction technique is single bundle reconstruction. However, this technique does not simulate the natural structure of the ligament. The purpose of the study is to compare between the common procedure, Single Bundle reconstruction with the Double Bundle reconstruction technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single bundle | Active comparator | Procedure: acle reconstruction - single bundle techniqueacl reconstruction - single bundle technique |
| double bundle | Experimental | Procedure: acl reconstruction - double bundle techniqueacl reconstruction - double bundle technique |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- knee instability with a history of ACL tear
- diagnosed ACL tear according to MRI
- age range 16-40.
Key exclusion criteria (8 listed)
- previous surgery in the knees
- multiple ligament raptures
- partial ACL tear
- severe cartilage degeneration
- genovaruse/genovalgus
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 |
|---|---|---|
| acl reconstruction - double bundle technique | Procedure or surgery | double bundle |
| acle reconstruction - single bundle technique | Procedure or surgery | single bundle |
Primary outcome
WOMAC, VAS, SF-36, Lisholm, Knee society score, isokinetic muscle strength testing, Single HOP test , Tripple Hop Test
Time frame: pre-op. 1 day post op., 7-14 days post op., 6 weeks post op., 12 weeks post op., 26 weeks post op., 1 year post op., 2 years post op.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2009.
Related trials for Anterior Cruciate Ligament Tear
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
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 Phase 4 study testing acl reconstruction - double bundle technique and acle reconstruction - single bundle technique in people with Anterior Cruciate Ligament Tear, run by Assaf-Harofeh Medical Center.
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 3 inclusion and 8 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 4 Dec 2009. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
WOMAC, VAS, SF-36, Lisholm, Knee society score, isokinetic muscle strength testing, Single HOP test , Tripple Hop Test (time frame: pre-op. 1 day post op., 7-14 days post op., 6 weeks post op., 12 weeks post op., 26 weeks post op., 1 year post op., 2 years post op.). 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 4 Dec 2009.