Anterior Cruciate Ligament TearPhase 2NCT01580722
Comparison of Early Versus Delay Reconstruction in Anterior Cruciate Ligament Tearing
A Phase 2 study testing early reconstruction and delay reconstruction in people with Anterior Cruciate Ligament Tear, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine which surgical method is better for anterior cruciate ligament teas in outcomes. Read more about this study
- Who is it for?
- Ages 18 to 36 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Tear
- What is being tested?
- early reconstruction and delay reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteIran
- Study dates
- Mar 2012to Apr 2012
- Phase
- Phase 2
- 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 36 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with confirmed anterior cruciate ligament tearing
Who cannot join
- One of the following associated injuries to the index knee as visualized on MRI and/or arthroscopy:
- An unstable longitudinal meniscus tear that requires repair and where the following postoperative treatment (i.e. bracing and limited ROM) interferes with the rehabilitation protocol
- Bi-compartmental extensive meniscus resections
- A cartilage injury representing a full thickness loss down to bone
- A total rupture of MCL/LCL as visualized on MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Surgical Methods for Anterior Cruciate Ligament Tearing
The purpose of this study is to determine which surgical method is better for anterior cruciate ligament teas in outcomes.
Read the detailed description
The anterior cruciate ligament (ACL) is one of the most commonly injured ligaments of the knee. This study was conducted to determine whether the outcome of treatment is superior in early surgical reconstruction compared with optional delay reconstruction.
- Conditions
- Anterior Cruciate Ligament Tear
- Being tested
- early reconstruction, delay reconstruction
- Keywords
- Anterior Cruciate Ligament,Early,Delay,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.
early reconstructionProcedure or surgery
patients underwent < 8 weeks reconstruction after injury
delay reconstructionProcedure or surgery
patients underwent > 8 weeks reconstruction after injury
| Study group | Role | What they receive |
|---|---|---|
| early | Other | patients underwent < 8 weeks reconstruction after injury Receives: Procedure: early reconstruction |
| delay | Other | patients underwent > 8 weeks reconstruction after injury Receives: Procedure: delay reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life
SF-36 questionnaire consists of 36 questions (two main components: physical and mental), each of which was assigned a score ranging from 0 to 100.
Measured: at 6 months post-operatively
Secondary outcomes (2)
Tegner activity score
The Tegner Activity Scale depicts the level of sporting activity and allows us to compare and document the preinjury activity level with the present activity level. This numeric score ranging from 1 to 10 where 1 is the least strenuous activity for the knee and 10 is the hardest.
Measured: at 6 months post-operatively
Knee injury and Osteoarthritis Outcome Score
The Knee injury and Osteoarthritis Outcome Score is the extended form of The Western Ontario and McMaster Universities Arthritis Index (WOMAC) with 42 - items in 5 subscales consisting : pain ( 9 items ) , other symptoms ( 7 items ) , activities of daily living ( 17 items ) , sports and recreational function ( sport / rec ) ( 5 items ) , and knee - related quality of life ( QOL ) ( 4 items ) .
Measured: at 6 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2012
- Study completionApr 2012
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamidreza Shemshaki, Isfahan University of Medical Sciences
- Investigators
- hamidreza shemshaki, MD, Study chair, MD,research comittee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580722
- Sponsor's protocol ID
- ASD-1213-100
- Status last verified
- Apr 2012
- First submitted
- 18 Apr 2012
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Surgical Methods for Anterior Cruciate Ligament Tearing
- ClinicalTrials.gov ID
- NCT01580722
- Acronym / sponsor ID
- ASD-1213-100
- Conditions
- Anterior Cruciate Ligament Tear
- Keywords
- Anterior Cruciate Ligament,Early,Delay,Reconstruction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 19 Apr 2012 (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 this study is to determine which surgical method is better for anterior cruciate ligament teas in outcomes.
Detailed description
The anterior cruciate ligament (ACL) is one of the most commonly injured ligaments of the knee. This study was conducted to determine whether the outcome of treatment is superior in early surgical reconstruction compared with optional delay reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early | Other | Procedure: early reconstructionpatients underwent < 8 weeks reconstruction after injury |
| delay | Other | Procedure: delay reconstructionpatients underwent > 8 weeks reconstruction after injury |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with confirmed anterior cruciate ligament tearing
Key exclusion criteria (5 listed)
- One of the following associated injuries to the index knee as visualized on MRI and/or arthroscopy:
- An unstable longitudinal meniscus tear that requires repair and where the following postoperative treatment (i.e. bracing and limited ROM) interferes with the rehabilitation protocol
- Bi-compartmental extensive meniscus resections
- A cartilage injury representing a full thickness loss down to bone
- A total rupture of MCL/LCL as visualized on MRI
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 |
|---|---|---|
| early reconstructionpatients underwent < 8 weeks reconstruction after injury | Procedure or surgery | early |
| delay reconstructionpatients underwent > 8 weeks reconstruction after injury | Procedure or surgery | delay |
Primary outcome
quality of life
Time frame: at 6 months post-operatively
SF-36 questionnaire consists of 36 questions (two main components: physical and mental), each of which was assigned a score ranging from 0 to 100.
2 secondary outcomes
Tegner activity score
Time frame: at 6 months post-operatively
Knee injury and Osteoarthritis Outcome Score
Time frame: at 6 months post-operatively
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 19 Apr 2012.
Related trials for Anterior Cruciate Ligament Tear
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
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
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.
hamidreza shemshaki, MD study chair
MD,research comittee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing early reconstruction and delay reconstruction in people with Anterior Cruciate Ligament Tear, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 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 19 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
quality of life (time frame: at 6 months post-operatively). 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 19 Apr 2012.