Primary ACL TearsNCT00364897
Investigation of Clinical Outcome of ACL Reconstruction Utilizing Two Tibial Fixation Techniques, Concentric Tapered Interference Screws and Interference Screw and Sheath
An observational study of Primary ACL Tears, run by Hadassah Medical Organization.
Trial summary
Tibial fixation is the weak link when using soft tissue grafts and interference screws for fixation in a bony tunnel in ACL reconstruction. The Objective is to study two groups of patients undergoing double loop hamstring autograft ACL reconstruction and compare between the two tibial fixation devices: the tapered… Read more about this study
- Who is it for?
- Ages 21 to 40 years
- Conditions the study is for
- Primary ACL Tears
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Observational
- 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 21 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females between ages 21 and 40 years.
- Primary ACL tears.
- Signed Informed consent.
- Availability during follow up period.
Who cannot join
- Additional meniscal injury requiring suture.
- Articular cartilage injury requiring surgical management.
- Concomitant ligament injuries to the same knee requiring surgery.
- Bilateral ACL injury.
- Revision ACL surgery.
- Concurrent fractures of the lower limbs caused by the same accident.
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- Post operative wound infection.
- Post operative nerve injury
- Cardiovascular compromise.
- Professional sports people.
- Soldiers on active military service.
- Patients actively seeking compensation for injury.
- Patients on other research protocols.
- Patients receiving medications which alter bone metabolism: corticosteriods, Calcitonin, Flourides, Biphosphonates, Vitamin D and its derivatives, Cytotoxic drugs.
- Non compliance. • Pregnancy
About this study
Official title: Comparison Between Two Tibial Fixation Techniques in ACL Reconstruction
Tibial fixation is the weak link when using soft tissue grafts and interference screws for fixation in a bony tunnel in ACL reconstruction. The Objective is to study two groups of patients undergoing double loop hamstring autograft ACL reconstruction and compare between the two tibial fixation devices: the tapered Deltascrew and the Intrafix screw and sheath .
- Conditions
- Primary ACL Tears
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary ACL TearsStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 140 participants
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Joseph Lowe, Dr., Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00364897
- Sponsor's protocol ID
- ACL001-HMO-CTIL
- Status last verified
- Feb 2007
- First submitted
- 15 Aug 2006
- Last updated
- 11 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Tibial Fixation Techniques in ACL Reconstruction
- ClinicalTrials.gov ID
- NCT00364897
- Acronym / sponsor ID
- ACL001-HMO-CTIL
- Conditions
- Primary ACL Tears
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 140 participants
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- First posted
- 16 Aug 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.
Tibial fixation is the weak link when using soft tissue grafts and interference screws for fixation in a bony tunnel in ACL reconstruction. The Objective is to study two groups of patients undergoing double loop hamstring autograft ACL reconstruction and compare between the two tibial fixation devices: the tapered Deltascrew and the Intrafix screw and sheath .
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and females between ages 21 and 40 years.
- Primary ACL tears.
- Signed Informed consent.
- Availability during follow up period.
Key exclusion criteria (15 listed)
- Additional meniscal injury requiring suture.
- Articular cartilage injury requiring surgical management.
- Concomitant ligament injuries to the same knee requiring surgery.
- Bilateral ACL injury.
- Revision ACL surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2007.
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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.
Joseph Lowe, Dr. principal investigator
Hadassah Medical Organization
Questions about this trial
What is this clinical trial studying?
An observational study of Primary ACL Tears, run by Hadassah Medical Organization.
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 4 inclusion and 15 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: withdrawn, as of the sponsor's last update on 11 Apr 2007. 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 was withdrawn before enrolling participants, so there are no results.
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.
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 11 Apr 2007.