NCT02473822

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2015

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2015

Completed
18 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 17, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 17, 2015

Status Verified

June 1, 2015

Enrollment Period

1 year

First QC Date

May 14, 2015

Last Update Submit

June 12, 2015

Conditions

Joint Trauma

Keywords

anterior cruciate ligamentTape Locking ScrewLCAjoint trauma

Outcome Measures

Primary Outcomes (1)

  • Resumption of sporting activities

    every 3 months over a period of one year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients undergoing care of knee instability in chronic laxity of anterior cruciate ligament by ligament according to TLS technique.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Jean-Yves JENNY, MD

    University Hospital, Strasbourg, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Yves JENNY, MD

CONTACT

33.3.88.55.21.45jean-yves.jenny@chru-strasbourg.fr

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2015

First Posted

June 17, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 17, 2015

Record last verified: 2015-06