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AzTrials

Anterior Cruciate Ligament RuptureBIORELICANCT03529552

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.

A study testing Anterior Cruciate Ligament Reconstruction in people with Anterior Cruciate Ligament Rupture, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Anterior Cruciate Ligament Rupture
What is being tested?
Anterior Cruciate Ligament Reconstruction
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesFrance
Study dates
17 Sep 2018to 24 Apr 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

3 sites in 1 country.

France3 sites

  • Polyclinique Urbain V

    Avignon, 84000

  • Centre Régina

    Nice, 06000

  • CHU Nimes

    Nîmes, 30029

Other trials in France

About this study

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.

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

Being tested
Anterior Cruciate Ligament Reconstruction
Medical subject headings
Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anterior Cruciate Ligament ReconstructionProcedure or surgery

    Placement of an SMS bioresorbable interference screw (DEDIENNE Santé)

Study groups in NCT03529552
Study groupRoleWhat they receive
Patients with anterior cruciate ligament ruptureExperimentalNot described
Receives: Procedure: Anterior Cruciate Ligament Reconstruction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In situ degradation of screw

    Assessed on T1 and proton density fat saturation MRI

    Measured: Year 3

Secondary outcomes (65)

  1. Knee stiffness

    Articular amplitude test

    Measured: Day -1

  2. Knee stiffness

    Articular amplitude test

    Measured: Day 0

  3. Knee stiffness

    Articular amplitude test

    Measured: Week 6

  4. Knee stiffness

    Articular amplitude test

    Measured: Month 3

  5. Knee stiffness

    Articular amplitude test

    Measured: Month 8

  6. Knee stiffness

    Articular amplitude test

    Measured: Year 1

  7. Knee stiffness

    Articular amplitude test

    Measured: Year 2

  8. Knee stiffness

    Articular amplitude test

    Measured: Year 3

  9. Knee mobility

    Anterior pull test

    Measured: Day -1

  10. Knee mobility

    Anterior pull test

    Measured: Day 0

  11. Knee mobility

    Anterior pull test

    Measured: Week 6

  12. Knee mobility

    Anterior pull test

    Measured: Month 3

  13. Knee mobility

    Anterior pull test

    Measured: Month 8

  14. Knee mobility

    Anterior pull test

    Measured: Year 1

  15. Knee mobility

    Anterior pull test

    Measured: Year 2

  16. Knee mobility

    Anterior pull test

    Measured: Year 3

  17. Lateral pivot shift of knee

    MacIntosh test

    Measured: Day -1

  18. Lateral pivot shift of knee

    MacIntosh test

    Measured: Day 0

  19. Lateral pivot shift of knee

    MacIntosh test

    Measured: Week 6

  20. Lateral pivot shift of knee

    MacIntosh test

    Measured: Month 3

  21. Lateral pivot shift of knee

    MacIntosh test

    Measured: Month 8

  22. Lateral pivot shift of knee

    MacIntosh test

    Measured: Year 1

  23. Lateral pivot shift of knee

    MacIntosh test

    Measured: Year 2

  24. Lateral pivot shift of knee

    MacIntosh test

    Measured: Year 3

  25. Impact of knee pain on daily life

    Lysholm Knee Scoring Scale

    Measured: Day -1

  26. Impact of knee pain on daily life

    Lysholm Knee Scoring Scale

    Measured: Day 0

  27. Impact of knee pain on daily life

    Lysholm Knee Scoring Scale

    Measured: Week 6

  28. Impact of knee pain on daily life

    Lysholm Knee Scoring Scale

    Measured: Month 3

  29. Impact of knee pain on daily life

    Lysholm Knee Scoring Scale

    Measured: Month 8

  30. Impact of knee pain on daily life

    Lysholm Knee Scoring Scale

    Measured: year 1

  31. Impact of knee pain on daily life

    Lysholm Knee Scoring Scale

    Measured: Year 2

  32. Impact of knee pain on daily life

    Lysholm Knee Scoring Scale

    Measured: Year 3

  33. Patient-reported knee problems

    International Knee Documentation Committee Questionnaire

    Measured: Day -1

  34. Patient-reported knee problems

    International Knee Documentation Committee Questionnaire

    Measured: Day 0

  35. Patient-reported knee problems

    International Knee Documentation Committee Questionnaire

    Measured: Week 6

  36. Patient-reported knee problems

    International Knee Documentation Committee Questionnaire

    Measured: Month 3

  37. Patient-reported knee problems

    International Knee Documentation Committee Questionnaire

    Measured: Month 8

  38. Patient-reported knee problems

    International Knee Documentation Committee Questionnaire

    Measured: Year 1

  39. Patient-reported knee problems

    International Knee Documentation Committee Questionnaire

    Measured: Year 2

  40. Patient-reported knee problems

    International Knee Documentation Committee Questionnaire

    Measured: Year 3

  41. Knee laxity

    KT-1000 measurement

    Measured: Day -1

  42. Knee laxity

    KT-1000 measurement

    Measured: Day 0

  43. Knee laxity

    KT-1000 measurement

    Measured: Week 6

  44. Knee laxity

    KT-1000 measurement

    Measured: Month 3

  45. Knee laxity

    KT-1000 measurement

    Measured: Month 8

  46. Knee laxity

    KT-1000 measurement

    Measured: Year 1

  47. Knee laxity

    KT-1000 measurement

    Measured: Year 2

  48. Knee laxity

    KT-1000 measurement

    Measured: Year 3

  49. Passive accessory movement of knee

    Lachman test

    Measured: Day -1

  50. Passive accessory movement of knee

    Lachman test

    Measured: Day 0

  51. Passive accessory movement of knee

    Lachman test

    Measured: Week 6

  52. Passive accessory movement of knee

    Lachman test

    Measured: Month 3

  53. Passive accessory movement of knee

    Lachman test

    Measured: Month 8

  54. Passive accessory movement of knee

    Lachman test

    Measured: Year 1

  55. Passive accessory movement of knee

    Lachman test

    Measured: Year 2

  56. Passive accessory movement of knee

    Lachman test

    Measured: Year 3

  57. Anterior cruciate ligament and posterior capsule integrity

    Pivot-shift test

    Measured: Day -1

  58. Anterior cruciate ligament and posterior capsule integrity

    Pivot-shift test

    Measured: Day 0

  59. Anterior cruciate ligament and posterior capsule integrity

    Pivot-shift test

    Measured: Week 6

  60. Anterior cruciate ligament and posterior capsule integrity

    Pivot-shift test

    Measured: Month 3

  61. Anterior cruciate ligament and posterior capsule integrity

    Pivot-shift test

    Measured: Month 8

  62. Anterior cruciate ligament and posterior capsule integrity

    Pivot-shift test

    Measured: Year 1

  63. Anterior cruciate ligament and posterior capsule integrity

    Pivot-shift test

    Measured: Year 2

  64. Anterior cruciate ligament and posterior capsule integrity

    Pivot-shift test

    Measured: Year 3

  65. Post-operative complications

    Undesirable events

    Measured: Year 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2018
  2. Study start17 Sep 2018
  3. Primary completion24 Apr 2019
  4. Study completion24 Apr 2019

Why it stopped: The Dm production has been stopped

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03529552
Sponsor's protocol ID
IDIL/2017/PM-01
Acronym
BIORELICA
Status last verified
Aug 2020
First submitted
7 May 2018
Last updated
5 Aug 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Anterior Cruciate Ligament Reconstruction in people with Anterior Cruciate Ligament Rupture, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The Dm production has been stopped). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In situ degradation of screw (time frame: Year 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03529552.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.

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