Torn Anterior Cruciate Ligament (Knee)NCT00221273
Use of Graft Tensioner Device in ACL (Knee) Repair
A study testing ACL surgery in people with Torn Anterior Cruciate Ligament (Knee), run by University of British Columbia.
Trial summary
Compares tension of an ACL graft when using a commercial device vs. the tension of the graft applied by a physician during surgery. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Torn Anterior Cruciate Ligament (Knee)
- What is being tested?
- ACL surgery
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to 18 May 2012
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Torn ACL amenable to surgery
Who cannot join
None listed.
About this study
Official title: Randomized Clinical Trial to Assess the Clinical Effectiveness of a Measured Objective Tensioning in Hamstring ACL Reconstruction
Compares tension of an ACL graft when using a commercial device vs. the tension of the graft applied by a physician during surgery.
- Conditions
- Torn Anterior Cruciate Ligament (Knee)
- Being tested
- ACL surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Endpoints Measured at 6, 12, 18 months post op compared to pre-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startDec 2010
- Primary completion18 May 2012
- Study completion18 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Torn Anterior Cruciate Ligament (Knee)Studies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J Leith, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221273
- Sponsor's protocol ID
- H05-70302
- Status last verified
- Mar 2017
- First submitted
- 18 Sep 2005
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Assess the Clinical Effectiveness of a Measured Objective Tensioning in Hamstring ACL Reconstruction
- ClinicalTrials.gov ID
- NCT00221273
- Acronym / sponsor ID
- H05-70302
- Conditions
- Torn Anterior Cruciate Ligament (Knee)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- 18 May 2012 (actual)
- Study completion
- 18 May 2012 (actual)
- First posted
- 22 Sep 2005 (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.
Compares tension of an ACL graft when using a commercial device vs. the tension of the graft applied by a physician during surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Torn ACL amenable to surgery
Key exclusion criteria (0 listed)
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 surgery | Procedure or surgery | – |
Primary outcome
Endpoints Measured at 6, 12, 18 months post op compared to pre-op
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 3 Mar 2017.
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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.
J Leith, MD principal investigator
University of British Columbia
Questions about this trial
What is this clinical trial studying?
A study testing ACL surgery in people with Torn Anterior Cruciate Ligament (Knee), run by University of British Columbia.
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 0 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 3 Mar 2017. 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?
Endpoints Measured at 6, 12, 18 months post op compared to pre-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 3 Mar 2017.