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. (BIORELICA)

C

Centre Hospitalier Universitaire de Nīmes

Status

Terminated

Conditions

Anterior Cruciate Ligament Rupture

Treatments

Procedure: Anterior Cruciate Ligament Reconstruction

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03529552
IDIL/2017/PM-01

Details and patient eligibility

About

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

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Patients with anterior cruciate ligament rupture
Experimental group
Treatment:
Procedure: Anterior Cruciate Ligament Reconstruction

Trial contacts and locations

3

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems