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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)

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ClinicalTrials.gov Identifier: NCT03529552
Recruitment Status : Terminated (The Dm production has been stopped)
First Posted : May 18, 2018
Last Update Posted : August 5, 2020
Sponsor:
Collaborator:
Dedienne Sante S.A.S.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Rupture Procedure: Anterior Cruciate Ligament Reconstruction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : September 17, 2018
Actual Primary Completion Date : April 24, 2019
Actual Study Completion Date : April 24, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with anterior cruciate ligament rupture Procedure: Anterior Cruciate Ligament Reconstruction
Placement of an SMS bioresorbable interference screw (DEDIENNE Santé)




Primary Outcome Measures :
  1. In situ degradation of screw [ Time Frame: Year 3 ]
    Assessed on T1 and proton density fat saturation MRI


Secondary Outcome Measures :
  1. Knee stiffness [ Time Frame: Day -1 ]
    Articular amplitude test

  2. Knee stiffness [ Time Frame: Day 0 ]
    Articular amplitude test

  3. Knee stiffness [ Time Frame: Week 6 ]
    Articular amplitude test

  4. Knee stiffness [ Time Frame: Month 3 ]
    Articular amplitude test

  5. Knee stiffness [ Time Frame: Month 8 ]
    Articular amplitude test

  6. Knee stiffness [ Time Frame: Year 1 ]
    Articular amplitude test

  7. Knee stiffness [ Time Frame: Year 2 ]
    Articular amplitude test

  8. Knee stiffness [ Time Frame: Year 3 ]
    Articular amplitude test

  9. Knee mobility [ Time Frame: Day -1 ]
    Anterior pull test

  10. Knee mobility [ Time Frame: Day 0 ]
    Anterior pull test

  11. Knee mobility [ Time Frame: Week 6 ]
    Anterior pull test

  12. Knee mobility [ Time Frame: Month 3 ]
    Anterior pull test

  13. Knee mobility [ Time Frame: Month 8 ]
    Anterior pull test

  14. Knee mobility [ Time Frame: Year 1 ]
    Anterior pull test

  15. Knee mobility [ Time Frame: Year 2 ]
    Anterior pull test

  16. Knee mobility [ Time Frame: Year 3 ]
    Anterior pull test

  17. Lateral pivot shift of knee [ Time Frame: Day -1 ]
    MacIntosh test

  18. Lateral pivot shift of knee [ Time Frame: Day 0 ]
    MacIntosh test

  19. Lateral pivot shift of knee [ Time Frame: Week 6 ]
    MacIntosh test

  20. Lateral pivot shift of knee [ Time Frame: Month 3 ]
    MacIntosh test

  21. Lateral pivot shift of knee [ Time Frame: Month 8 ]
    MacIntosh test

  22. Lateral pivot shift of knee [ Time Frame: Year 1 ]
    MacIntosh test

  23. Lateral pivot shift of knee [ Time Frame: Year 2 ]
    MacIntosh test

  24. Lateral pivot shift of knee [ Time Frame: Year 3 ]
    MacIntosh test

  25. Impact of knee pain on daily life [ Time Frame: Day -1 ]
    Lysholm Knee Scoring Scale

  26. Impact of knee pain on daily life [ Time Frame: Day 0 ]
    Lysholm Knee Scoring Scale

  27. Impact of knee pain on daily life [ Time Frame: Week 6 ]
    Lysholm Knee Scoring Scale

  28. Impact of knee pain on daily life [ Time Frame: Month 3 ]
    Lysholm Knee Scoring Scale

  29. Impact of knee pain on daily life [ Time Frame: Month 8 ]
    Lysholm Knee Scoring Scale

  30. Impact of knee pain on daily life [ Time Frame: year 1 ]
    Lysholm Knee Scoring Scale

  31. Impact of knee pain on daily life [ Time Frame: Year 2 ]
    Lysholm Knee Scoring Scale

  32. Impact of knee pain on daily life [ Time Frame: Year 3 ]
    Lysholm Knee Scoring Scale

  33. Patient-reported knee problems [ Time Frame: Day -1 ]
    International Knee Documentation Committee Questionnaire

  34. Patient-reported knee problems [ Time Frame: Day 0 ]
    International Knee Documentation Committee Questionnaire

  35. Patient-reported knee problems [ Time Frame: Week 6 ]
    International Knee Documentation Committee Questionnaire

  36. Patient-reported knee problems [ Time Frame: Month 3 ]
    International Knee Documentation Committee Questionnaire

  37. Patient-reported knee problems [ Time Frame: Month 8 ]
    International Knee Documentation Committee Questionnaire

  38. Patient-reported knee problems [ Time Frame: Year 1 ]
    International Knee Documentation Committee Questionnaire

  39. Patient-reported knee problems [ Time Frame: Year 2 ]
    International Knee Documentation Committee Questionnaire

  40. Patient-reported knee problems [ Time Frame: Year 3 ]
    International Knee Documentation Committee Questionnaire

  41. Knee laxity [ Time Frame: Day -1 ]
    KT-1000 measurement

  42. Knee laxity [ Time Frame: Day 0 ]
    KT-1000 measurement

  43. Knee laxity [ Time Frame: Week 6 ]
    KT-1000 measurement

  44. Knee laxity [ Time Frame: Month 3 ]
    KT-1000 measurement

  45. Knee laxity [ Time Frame: Month 8 ]
    KT-1000 measurement

  46. Knee laxity [ Time Frame: Year 1 ]
    KT-1000 measurement

  47. Knee laxity [ Time Frame: Year 2 ]
    KT-1000 measurement

  48. Knee laxity [ Time Frame: Year 3 ]
    KT-1000 measurement

  49. Passive accessory movement of knee [ Time Frame: Day -1 ]
    Lachman test

  50. Passive accessory movement of knee [ Time Frame: Day 0 ]
    Lachman test

  51. Passive accessory movement of knee [ Time Frame: Week 6 ]
    Lachman test

  52. Passive accessory movement of knee [ Time Frame: Month 3 ]
    Lachman test

  53. Passive accessory movement of knee [ Time Frame: Month 8 ]
    Lachman test

  54. Passive accessory movement of knee [ Time Frame: Year 1 ]
    Lachman test

  55. Passive accessory movement of knee [ Time Frame: Year 2 ]
    Lachman test

  56. Passive accessory movement of knee [ Time Frame: Year 3 ]
    Lachman test

  57. Anterior cruciate ligament and posterior capsule integrity [ Time Frame: Day -1 ]
    Pivot-shift test

  58. Anterior cruciate ligament and posterior capsule integrity [ Time Frame: Day 0 ]
    Pivot-shift test

  59. Anterior cruciate ligament and posterior capsule integrity [ Time Frame: Week 6 ]
    Pivot-shift test

  60. Anterior cruciate ligament and posterior capsule integrity [ Time Frame: Month 3 ]
    Pivot-shift test

  61. Anterior cruciate ligament and posterior capsule integrity [ Time Frame: Month 8 ]
    Pivot-shift test

  62. Anterior cruciate ligament and posterior capsule integrity [ Time Frame: Year 1 ]
    Pivot-shift test

  63. Anterior cruciate ligament and posterior capsule integrity [ Time Frame: Year 2 ]
    Pivot-shift test

  64. Anterior cruciate ligament and posterior capsule integrity [ Time Frame: Year 3 ]
    Pivot-shift test

  65. Post-operative complications [ Time Frame: Year 3 ]
    Undesirable events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529552


Locations
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France
Polyclinique Urbain V
Avignon, France, 84000
Centre Régina
Nice, France, 06000
CHU Nimes
Nîmes, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Dedienne Sante S.A.S.
Investigators
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Principal Investigator: Philippe Marchand, MD CHU Nimes
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03529552    
Other Study ID Numbers: IDIL/2017/PM-01
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Postoperative Complications
Rupture
Wounds and Injuries
Pathologic Processes