Joint TraumaNCT02473822
ACL Reconstruction With the TLS Technique
An observational study of Joint Trauma, run by University Hospital, Strasbourg, France.
Trial summary
This is a non-interventional study to retrospectively validate the technical use TLS (Tape Locking Screw) in the anterior cruciate ligament. The investigators goal is to test the validity of the technique and its positive influence on the resumption of sporting activities in relation to the existing literature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Joint Trauma
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jun 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing care of knee instability in chronic laxity of anterior cruciate ligament by ligament according to TLS technique.
Who may be able to join
- Patients over 18 years
- Patients operated in the service in 2014 to care for end-stage knee osteoarthritis by implantation of a total knee prosthesis.
Who cannot join
- Patients under 18 years
Trial locations and contacts
No sites are listed yet.
About this study
Official title: ACL Reconstruction With the TLS Technique (Tape Locking Screw) and Return to Sport: Serial 5-year Independent Designers
This is a non-interventional study to retrospectively validate the technical use TLS (Tape Locking Screw) in the anterior cruciate ligament. The investigators goal is to test the validity of the technique and its positive influence on the resumption of sporting activities in relation to the existing literature.
- Conditions
- Joint Trauma
- Keywords
- anterior cruciate ligament, Tape Locking Screw, LCA, joint trauma
What is being measured
The primary outcome is the main question the study is designed to answer.
Resumption of sporting activities
Measured: every 3 months over a period of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint TraumaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Yves JENNY, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473822
- Sponsor's protocol ID
- 2015-24
- Status last verified
- Jun 2015
- First submitted
- 14 May 2015
- Last updated
- 17 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACL Reconstruction With the TLS Technique (Tape Locking Screw) and Return to Sport: Serial 5-year Independent Designers
- ClinicalTrials.gov ID
- NCT02473822
- Acronym / sponsor ID
- 2015-24
- Conditions
- Joint Trauma
- Keywords
- anterior cruciate ligament, Tape Locking Screw, LCA, joint trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 17 Jun 2015 (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.
This is a non-interventional study to retrospectively validate the technical use TLS (Tape Locking Screw) in the anterior cruciate ligament. The investigators goal is to test the validity of the technique and its positive influence on the resumption of sporting activities in relation to the existing literature.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing care of knee instability in chronic laxity of anterior cruciate ligament by ligament according to TLS technique.
Key inclusion criteria (2 listed)
- Patients over 18 years
- Patients operated in the service in 2014 to care for end-stage knee osteoarthritis by implantation of a total knee prosthesis.
Key exclusion criteria (1 listed)
- Patients under 18 years
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
Resumption of sporting activities
Time frame: every 3 months over a period of one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 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.
Jean-Yves JENNY, MD principal investigator
University Hospital, Strasbourg, France
Questions about this trial
What is this clinical trial studying?
An observational study of Joint Trauma, run by University Hospital, Strasbourg, France.
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 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: status not confirmed, as of the sponsor's last update on 17 Jun 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Yves JENNY, MD (33.3.88.55.21.45, jean-yves.jenny@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resumption of sporting activities (time frame: every 3 months over a period of one year). 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 17 Jun 2015.