TerminatedNot Applicable

Anterior Cruciate Ligament Reconstruction: Residual Rotational Laxity for Single Versus Double Bundle Techniques

Stopped: Patient enrolment proved to be more difficult than foreseen and was stopped at 46 inclusions.

France46 participantsStarted 2011-10

Plain-language summary

The main objective of this study is to compare, using MRI measures with a specialized splint, the persistent rotatory laxity after anterior cruciate ligament reconstruction using single bundle and double bundle surgical techniques, between the seventh and eighth months after surgery, and for different degrees of knee flexion (0 °, 20 °, 40 °, 60 °).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * The patient must have given his/her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan * The patient is available for 24 months of follow-up * The patient requires reconstruction of the anterior cruciate ligament due to rupture confirmed by MRI Exclusion Criteria: * The patient is in an exclusion period determined by a previous study * The patient is under judicial protection, under tutorship or curatorship * The patient refuses to sign the consent * It is impossible to correctly inform the patient * The patient is pregnant * The patient is breastfeeding * The patient require a single bundle, "KJ-type" surgical technique * Contra-indication for MRI scans

What they're measuring

Residual rotational laxity during MRI

Timeframe: 7-8 months post-op

Trial details

NCT IDNCT01377129

SponsorCentre Hospitalier Universitaire de Nīmes

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-09

View on ClinicalTrials.gov More Anterior Cruciate Ligament Injury trials