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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)

Primary Purpose

Anterior Cruciate Ligament Rupture

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Anterior Cruciate Ligament Reconstruction
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Rupture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Polyclinique Urbain V
  • Centre Régina
  • CHU Nimes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with anterior cruciate ligament rupture

Arm Description

Outcomes

Primary Outcome Measures

In situ degradation of screw
Assessed on T1 and proton density fat saturation MRI

Secondary Outcome Measures

Knee stiffness
Articular amplitude test
Knee stiffness
Articular amplitude test
Knee stiffness
Articular amplitude test
Knee stiffness
Articular amplitude test
Knee stiffness
Articular amplitude test
Knee stiffness
Articular amplitude test
Knee stiffness
Articular amplitude test
Knee stiffness
Articular amplitude test
Knee mobility
Anterior pull test
Knee mobility
Anterior pull test
Knee mobility
Anterior pull test
Knee mobility
Anterior pull test
Knee mobility
Anterior pull test
Knee mobility
Anterior pull test
Knee mobility
Anterior pull test
Knee mobility
Anterior pull test
Lateral pivot shift of knee
MacIntosh test
Lateral pivot shift of knee
MacIntosh test
Lateral pivot shift of knee
MacIntosh test
Lateral pivot shift of knee
MacIntosh test
Lateral pivot shift of knee
MacIntosh test
Lateral pivot shift of knee
MacIntosh test
Lateral pivot shift of knee
MacIntosh test
Lateral pivot shift of knee
MacIntosh test
Impact of knee pain on daily life
Lysholm Knee Scoring Scale
Impact of knee pain on daily life
Lysholm Knee Scoring Scale
Impact of knee pain on daily life
Lysholm Knee Scoring Scale
Impact of knee pain on daily life
Lysholm Knee Scoring Scale
Impact of knee pain on daily life
Lysholm Knee Scoring Scale
Impact of knee pain on daily life
Lysholm Knee Scoring Scale
Impact of knee pain on daily life
Lysholm Knee Scoring Scale
Impact of knee pain on daily life
Lysholm Knee Scoring Scale
Patient-reported knee problems
International Knee Documentation Committee Questionnaire
Patient-reported knee problems
International Knee Documentation Committee Questionnaire
Patient-reported knee problems
International Knee Documentation Committee Questionnaire
Patient-reported knee problems
International Knee Documentation Committee Questionnaire
Patient-reported knee problems
International Knee Documentation Committee Questionnaire
Patient-reported knee problems
International Knee Documentation Committee Questionnaire
Patient-reported knee problems
International Knee Documentation Committee Questionnaire
Patient-reported knee problems
International Knee Documentation Committee Questionnaire
Knee laxity
KT-1000 measurement
Knee laxity
KT-1000 measurement
Knee laxity
KT-1000 measurement
Knee laxity
KT-1000 measurement
Knee laxity
KT-1000 measurement
Knee laxity
KT-1000 measurement
Knee laxity
KT-1000 measurement
Knee laxity
KT-1000 measurement
Passive accessory movement of knee
Lachman test
Passive accessory movement of knee
Lachman test
Passive accessory movement of knee
Lachman test
Passive accessory movement of knee
Lachman test
Passive accessory movement of knee
Lachman test
Passive accessory movement of knee
Lachman test
Passive accessory movement of knee
Lachman test
Passive accessory movement of knee
Lachman test
Anterior cruciate ligament and posterior capsule integrity
Pivot-shift test
Anterior cruciate ligament and posterior capsule integrity
Pivot-shift test
Anterior cruciate ligament and posterior capsule integrity
Pivot-shift test
Anterior cruciate ligament and posterior capsule integrity
Pivot-shift test
Anterior cruciate ligament and posterior capsule integrity
Pivot-shift test
Anterior cruciate ligament and posterior capsule integrity
Pivot-shift test
Anterior cruciate ligament and posterior capsule integrity
Pivot-shift test
Anterior cruciate ligament and posterior capsule integrity
Pivot-shift test
Post-operative complications
Undesirable events

Full Information

First Posted
May 7, 2018
Last Updated
August 3, 2020
Sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
Dedienne Sante S.A.S.
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1. Study Identification

Unique Protocol Identification Number
NCT03529552
Brief Title
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.
Acronym
BIORELICA
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
The Dm production has been stopped
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
April 24, 2019 (Actual)
Study Completion Date
April 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
Dedienne Sante S.A.S.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Rupture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with anterior cruciate ligament rupture
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Anterior Cruciate Ligament Reconstruction
Intervention Description
Placement of an SMS bioresorbable interference screw (DEDIENNE Santé)
Primary Outcome Measure Information:
Title
In situ degradation of screw
Description
Assessed on T1 and proton density fat saturation MRI
Time Frame
Year 3
Secondary Outcome Measure Information:
Title
Knee stiffness
Description
Articular amplitude test
Time Frame
Day -1
Title
Knee stiffness
Description
Articular amplitude test
Time Frame
Day 0
Title
Knee stiffness
Description
Articular amplitude test
Time Frame
Week 6
Title
Knee stiffness
Description
Articular amplitude test
Time Frame
Month 3
Title
Knee stiffness
Description
Articular amplitude test
Time Frame
Month 8
Title
Knee stiffness
Description
Articular amplitude test
Time Frame
Year 1
Title
Knee stiffness
Description
Articular amplitude test
Time Frame
Year 2
Title
Knee stiffness
Description
Articular amplitude test
Time Frame
Year 3
Title
Knee mobility
Description
Anterior pull test
Time Frame
Day -1
Title
Knee mobility
Description
Anterior pull test
Time Frame
Day 0
Title
Knee mobility
Description
Anterior pull test
Time Frame
Week 6
Title
Knee mobility
Description
Anterior pull test
Time Frame
Month 3
Title
Knee mobility
Description
Anterior pull test
Time Frame
Month 8
Title
Knee mobility
Description
Anterior pull test
Time Frame
Year 1
Title
Knee mobility
Description
Anterior pull test
Time Frame
Year 2
Title
Knee mobility
Description
Anterior pull test
Time Frame
Year 3
Title
Lateral pivot shift of knee
Description
MacIntosh test
Time Frame
Day -1
Title
Lateral pivot shift of knee
Description
MacIntosh test
Time Frame
Day 0
Title
Lateral pivot shift of knee
Description
MacIntosh test
Time Frame
Week 6
Title
Lateral pivot shift of knee
Description
MacIntosh test
Time Frame
Month 3
Title
Lateral pivot shift of knee
Description
MacIntosh test
Time Frame
Month 8
Title
Lateral pivot shift of knee
Description
MacIntosh test
Time Frame
Year 1
Title
Lateral pivot shift of knee
Description
MacIntosh test
Time Frame
Year 2
Title
Lateral pivot shift of knee
Description
MacIntosh test
Time Frame
Year 3
Title
Impact of knee pain on daily life
Description
Lysholm Knee Scoring Scale
Time Frame
Day -1
Title
Impact of knee pain on daily life
Description
Lysholm Knee Scoring Scale
Time Frame
Day 0
Title
Impact of knee pain on daily life
Description
Lysholm Knee Scoring Scale
Time Frame
Week 6
Title
Impact of knee pain on daily life
Description
Lysholm Knee Scoring Scale
Time Frame
Month 3
Title
Impact of knee pain on daily life
Description
Lysholm Knee Scoring Scale
Time Frame
Month 8
Title
Impact of knee pain on daily life
Description
Lysholm Knee Scoring Scale
Time Frame
year 1
Title
Impact of knee pain on daily life
Description
Lysholm Knee Scoring Scale
Time Frame
Year 2
Title
Impact of knee pain on daily life
Description
Lysholm Knee Scoring Scale
Time Frame
Year 3
Title
Patient-reported knee problems
Description
International Knee Documentation Committee Questionnaire
Time Frame
Day -1
Title
Patient-reported knee problems
Description
International Knee Documentation Committee Questionnaire
Time Frame
Day 0
Title
Patient-reported knee problems
Description
International Knee Documentation Committee Questionnaire
Time Frame
Week 6
Title
Patient-reported knee problems
Description
International Knee Documentation Committee Questionnaire
Time Frame
Month 3
Title
Patient-reported knee problems
Description
International Knee Documentation Committee Questionnaire
Time Frame
Month 8
Title
Patient-reported knee problems
Description
International Knee Documentation Committee Questionnaire
Time Frame
Year 1
Title
Patient-reported knee problems
Description
International Knee Documentation Committee Questionnaire
Time Frame
Year 2
Title
Patient-reported knee problems
Description
International Knee Documentation Committee Questionnaire
Time Frame
Year 3
Title
Knee laxity
Description
KT-1000 measurement
Time Frame
Day -1
Title
Knee laxity
Description
KT-1000 measurement
Time Frame
Day 0
Title
Knee laxity
Description
KT-1000 measurement
Time Frame
Week 6
Title
Knee laxity
Description
KT-1000 measurement
Time Frame
Month 3
Title
Knee laxity
Description
KT-1000 measurement
Time Frame
Month 8
Title
Knee laxity
Description
KT-1000 measurement
Time Frame
Year 1
Title
Knee laxity
Description
KT-1000 measurement
Time Frame
Year 2
Title
Knee laxity
Description
KT-1000 measurement
Time Frame
Year 3
Title
Passive accessory movement of knee
Description
Lachman test
Time Frame
Day -1
Title
Passive accessory movement of knee
Description
Lachman test
Time Frame
Day 0
Title
Passive accessory movement of knee
Description
Lachman test
Time Frame
Week 6
Title
Passive accessory movement of knee
Description
Lachman test
Time Frame
Month 3
Title
Passive accessory movement of knee
Description
Lachman test
Time Frame
Month 8
Title
Passive accessory movement of knee
Description
Lachman test
Time Frame
Year 1
Title
Passive accessory movement of knee
Description
Lachman test
Time Frame
Year 2
Title
Passive accessory movement of knee
Description
Lachman test
Time Frame
Year 3
Title
Anterior cruciate ligament and posterior capsule integrity
Description
Pivot-shift test
Time Frame
Day -1
Title
Anterior cruciate ligament and posterior capsule integrity
Description
Pivot-shift test
Time Frame
Day 0
Title
Anterior cruciate ligament and posterior capsule integrity
Description
Pivot-shift test
Time Frame
Week 6
Title
Anterior cruciate ligament and posterior capsule integrity
Description
Pivot-shift test
Time Frame
Month 3
Title
Anterior cruciate ligament and posterior capsule integrity
Description
Pivot-shift test
Time Frame
Month 8
Title
Anterior cruciate ligament and posterior capsule integrity
Description
Pivot-shift test
Time Frame
Year 1
Title
Anterior cruciate ligament and posterior capsule integrity
Description
Pivot-shift test
Time Frame
Year 2
Title
Anterior cruciate ligament and posterior capsule integrity
Description
Pivot-shift test
Time Frame
Year 3
Title
Post-operative complications
Description
Undesirable events
Time Frame
Year 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Marchand, MD
Organizational Affiliation
CHU Nimes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Polyclinique Urbain V
City
Avignon
ZIP/Postal Code
84000
Country
France
Facility Name
Centre Régina
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
CHU Nimes
City
Nîmes
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

Learn more about this trial

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.

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