Anterior Cruciate Ligament ReconstructionPhase 4NCT00300300
Anterior Cruciate Ligament (ACL) Reconstruction Using Different Grafts and Surgical Techniques
A Phase 4 study testing Computer-assisted surgery in people with Anterior Cruciate Ligament Reconstruction, run by Queen's University at 1 site in Canada.
Trial summary
ACL reconstruction in the Division of Orthopaedic surgery at Queen's is currently being performed arthroscopically assisted. The resultant function of the reconstructed ligament is greatly influenced by the placement of the transosseous tunnels, which are tunnels in the bones through which the grafts pass. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Computer-assisted surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2009to Jan 2029
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of a chronic unilateral rupture of the anterior cruciate ligament
- Aged 18-40
Who cannot join
- Acute injury of the ACL (interval between the injury and operation is < 30 days).
- Other ligament tears and/or operation on the operative knee (with the exception of a previous meniscectomy).
- Injury of the contralateral knee.
- Degenerative changes of the articular cartilage (grade III or IV changes according to the Outerbrige classification system)
- Complaints of patellofemoral symptoms
- Patient is pregnant
- Inability to complete 2-year follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anterior Cruciate Ligament Reconstruction: Comparison of Patellar With Hamstring Tendon Using a Computer-assisted Versus a Conventional Surgical Technique.
ACL reconstruction in the Division of Orthopaedic surgery at Queen's is currently being performed arthroscopically assisted. The resultant function of the reconstructed ligament is greatly influenced by the placement of the transosseous tunnels, which are tunnels in the bones through which the grafts pass. Presently the placement of the tunnels is being judged from arthroscopically identified anatomical landmarks within the joint. The result is incidence rates of misplaced tunnels as high as 40%. Computer assisted tunnel placement would aid in the correction and reproducibility of anatomic tunnel placement. The objective of this study is to conduct a prospective, randomized trial comparing clinical and radiographic outcomes in subjects who receive either a patella or hamstring tendon graft to reconstruct a chronic tear of the anterior cruciate ligament. All subjects will be further randomized into a computer-assisted or a conventional arthroscopic surgical group to allow investigators to compare the precision and accuracy of tunnel placement between these surgical approaches. The main question under investigation is: does the increased accuracy of computer-assisted surgery make a clinical difference to the laxity of the reconstructed knee, and is the laxity further influenced by the type of tendon graft received?
- Being tested
- Computer-assisted surgery
- Keywords
- ACL computer-assisted surgery graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-assisted surgeryProcedure or surgery
no description
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | applying a patellar graft using conventional surgical technique. |
| 2 | No intervention | applying a hamstring graft using conventional surgical technique. |
| 3 | Experimental | applying a patellar graft using a computer-assisted surgy technique. Receives: Procedure: Computer-assisted surgery |
| 4 | Experimental | hamstring graft CAOS Receives: Procedure: Computer-assisted surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main outcome under investigation is knee laxity as reflected by graft tension.
Measured: 2 years
Secondary outcomes (1)
Other outcomes of interest include graft isometry, position and size as well as knee pain, stiffness, function, and range of motion.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2006 (estimated)
- Study startSep 2009
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Why it stopped: Study temporarily suspended until funding can be secured.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. David Bardana, Queen's University
- Investigators
- Davide Bardana, MD, Principal investigator, Queen's University (faculty)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300300
- Sponsor's protocol ID
- Bard0105
- Status last verified
- Sep 2015
- First submitted
- 6 Mar 2006
- Last updated
- 10 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Cruciate Ligament Reconstruction: Comparison of Patellar With Hamstring Tendon Using a Computer-assisted Versus a Conventional Surgical Technique.
- ClinicalTrials.gov ID
- NCT00300300
- Acronym / sponsor ID
- Bard0105
- Keywords
- ACL computer-assisted surgery graft
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study temporarily suspended until funding can be secured.
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 8 Mar 2006 (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 reconstruction in the Division of Orthopaedic surgery at Queen's is currently being performed arthroscopically assisted. The resultant function of the reconstructed ligament is greatly influenced by the placement of the transosseous tunnels, which are tunnels in the bones through which the grafts pass. Presently the placement of the tunnels is being judged from arthroscopically identified anatomical landmarks within the joint. The result is incidence rates of misplaced tunnels as high as 40%. Computer assisted tunnel placement would aid in the correction and reproducibility of anatomic tunnel placement. The objective of this study is to conduct a prospective, randomized trial comparing clinical and radiographic outcomes in subjects who receive either a patella or hamstring tendon graft to reconstruct a chronic tear of the anterior cruciate ligament. All subjects will be further randomized into a computer-assisted or a conventional arthroscopic surgical group to allow investigators to compare the precision and accuracy of tunnel placement between these surgical approaches. The main question under investigation is: does the increased accuracy of computer-assisted surgery make a clinical difference to the laxity of the reconstructed knee, and is the laxity further influenced by the type of tendon graft received?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –applying a patellar graft using conventional surgical technique. |
| 2 | No intervention | –applying a hamstring graft using conventional surgical technique. |
| 3 | Experimental | Procedure: Computer-assisted surgeryapplying a patellar graft using a computer-assisted surgy technique. |
| 4 | Experimental | Procedure: Computer-assisted surgeryhamstring graft CAOS |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of a chronic unilateral rupture of the anterior cruciate ligament
- Aged 18-40
Key exclusion criteria (7 listed)
- Acute injury of the ACL (interval between the injury and operation is < 30 days).
- Other ligament tears and/or operation on the operative knee (with the exception of a previous meniscectomy).
- Injury of the contralateral knee.
- Degenerative changes of the articular cartilage (grade III or IV changes according to the Outerbrige classification system)
- Complaints of patellofemoral symptoms
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 |
|---|---|---|
| Computer-assisted surgeryno description | Procedure or surgery | 3, 4 |
Primary outcome
The main outcome under investigation is knee laxity as reflected by graft tension.
Time frame: 2 years
1 secondary outcome
Other outcomes of interest include graft isometry, position and size as well as knee pain, stiffness, function, and range of motion.
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Study temporarily suspended until funding can be secured.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2015.
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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.
Davide Bardana, MD principal investigator
Queen's University (faculty)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Computer-assisted surgery in people with Anterior Cruciate Ligament Reconstruction, run by Queen's University at 1 site in Canada.
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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 10 Sep 2015. 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 Canada. 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 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?
The study was stopped early (reason given: Study temporarily suspended until funding can be secured.). 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?
The main outcome under investigation is knee laxity as reflected by graft tension. (time frame: 2 years). 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 10 Sep 2015.