Anterior Cruciate Ligament RupturePhase 2NCT01267435
Evaluation of Tibial and Femoral Tunnel Position After Arthroscopic Reconstruction of the Anterior Cruciate Ligament
A Phase 2 study testing Anterior cruciate ligament reconstruction in people with Anterior Cruciate Ligament Rupture, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to evaluate the accuracy of tunnel positions in anterior cruciate ligament reconstruction Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- Anterior cruciate ligament reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- Oct 2008to Mar 2010
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- anterior cruciate ligament rupturing
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Evaluation of Tibial and Femoral Tunnel Position After ACL Reconstruction
The purpose of this study is to evaluate the accuracy of tunnel positions in anterior cruciate ligament reconstruction
Read the detailed description
The tunnel placement in ACL reconstruction is the most important predictor of clinical outcome and there is a high rate of inaccurate tunnel placements, even when performed by experienced surgeons.Tibial and femoral tunnel positions are one of the major concerns in anterior cruciate ligament reconstruction which have a great impact on the final surgical results
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- Anterior cruciate ligament reconstruction
- Keywords
- Arthroscopy, Anterior Cruciate Ligament, Tibial Tunnel.
- 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.
Anterior cruciate ligament reconstructionProcedure or surgery
Also called ACL reconstruction
reconstruct the anterior cruciate ligament rupturing
| Study group | Role | What they receive |
|---|---|---|
| determining correct tunnel positions | Other | Not described Receives: Procedure: Anterior cruciate ligament reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of correct femoral tunnel position
we evalauted femoral tunnel positions
Measured: 5 min after operation
Secondary outcomes (1)
number of correct Tibial tunnel position
we evalauted tibial tunnel position
Measured: 5 min after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2010 (estimated)
- Study startOct 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Investigators
- hamidreza shemshaki, MD, Study chair, research comittee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267435
- Sponsor's protocol ID
- ASD-1213-8
- Status last verified
- Oct 2008
- First submitted
- 27 Dec 2010
- Last updated
- 28 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Evaluation of Tibial and Femoral Tunnel Position After ACL Reconstruction
- ClinicalTrials.gov ID
- NCT01267435
- Acronym / sponsor ID
- ASD-1213-8
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- Arthroscopy, Anterior Cruciate Ligament, Tibial Tunnel.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Study start
- Oct 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 28 Dec 2010 (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 evaluate the accuracy of tunnel positions in anterior cruciate ligament reconstruction
Detailed description
The tunnel placement in ACL reconstruction is the most important predictor of clinical outcome and there is a high rate of inaccurate tunnel placements, even when performed by experienced surgeons.Tibial and femoral tunnel positions are one of the major concerns in anterior cruciate ligament reconstruction which have a great impact on the final surgical results
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| determining correct tunnel positions | Other | Procedure: Anterior cruciate ligament reconstruction |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- anterior cruciate ligament rupturing
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Anterior cruciate ligament reconstructionAlso: ACL reconstructionreconstruct the anterior cruciate ligament rupturing | Procedure or surgery | determining correct tunnel positions |
Primary outcome
number of correct femoral tunnel position
Time frame: 5 min after operation
we evalauted femoral tunnel positions
1 secondary outcome
number of correct Tibial tunnel position
Time frame: 5 min after operation
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 28 Dec 2010.
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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.
hamidreza shemshaki, MD study chair
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 Anterior cruciate ligament reconstruction in people with Anterior Cruciate Ligament Rupture, 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 1 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 28 Dec 2010. 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?
number of correct femoral tunnel position (time frame: 5 min after operation). 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 28 Dec 2010.