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Clinical Trials/NCT03529552
NCT03529552TerminatedNot Applicable

Short-, Medium- and Long-term (up to 3 Years) Evaluation After Reconstruction of the Anterior Cruciate Ligament of the Knee Using the Bioresorbable Interference Screw (SMS): Resorbability, Per- and Post-operative Complications and Articular Functional Recovery.

Centre Hospitalier Universitaire de Nīmes6 sites in 1 country40 target enrollmentStarted: September 17, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
40
Locations
6
Primary Endpoint
In situ degradation of screw
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The investigators will evaluate the benefit of a new bioresorbable screw for repair of anterior cruciate ligament over 3 years.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •The patient must have given their free and informed consent and signed the consent form
  • •The patient must be a member or beneficiary of a health insurance plan
  • •The patient is at least 18 years old
  • •The patient is available for at least 3 years of follow-up
  • •The patient requires ligamentoplasty pour rupture of anterior cruciate ligament confirmed by MRI with or without meniscal lesions as scheduled surgery

Exclusion Criteria

  • •The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
  • •The subject refuses to sign the consent
  • •It is impossible to give the subject informed information
  • •The patient is under safeguard of justice or state guardianship
  • •The patient is pregnant or breast-feeding
  • •The patient has a contra-indication (or a medically-incompatible association) for the treatment, including MRI
  • •Revision surgery
  • •Simultaneous surgery

Outcomes

Primary Outcomes

In situ degradation of screw

Time Frame: Year 3

Assessed on T1 and proton density fat saturation MRI

Secondary Outcomes

  • Passive accessory movement of knee(Year 3)
  • Knee mobility(Year 3)
  • Patient-reported knee problems(Year 3)
  • Anterior cruciate ligament and posterior capsule integrity(Year 3)
  • Post-operative complications(Year 3)
  • Lateral pivot shift of knee(Year 3)
  • Impact of knee pain on daily life(Year 3)
  • Knee laxity(Year 3)
  • Knee stiffness(Year 3)

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (6)

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