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)

August 3, 2020 updated by: Centre Hospitalier Universitaire de Nīmes

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Avignon, France, 84000
        • Polyclinique Urbain V
      • Nice, France, 06000
        • Centre Régina
      • Nîmes, France, 30029
        • CHU Nîmes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patients with anterior cruciate ligament rupture
Procedure: Anterior Cruciate Ligament Reconstruction
Placement of an SMS bioresorbable interference screw (DEDIENNE Santé)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
In situ degradation of screw
Time Frame: Year 3
Assessed on T1 and proton density fat saturation MRI
Year 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Knee stiffness
Time Frame: Day -1
Articular amplitude test
Day -1
Knee stiffness
Time Frame: Day 0
Articular amplitude test
Day 0
Knee stiffness
Time Frame: Week 6
Articular amplitude test
Week 6
Knee stiffness
Time Frame: Month 3
Articular amplitude test
Month 3
Knee stiffness
Time Frame: Month 8
Articular amplitude test
Month 8
Knee stiffness
Time Frame: Year 1
Articular amplitude test
Year 1
Knee stiffness
Time Frame: Year 2
Articular amplitude test
Year 2
Knee stiffness
Time Frame: Year 3
Articular amplitude test
Year 3
Knee mobility
Time Frame: Day -1
Anterior pull test
Day -1
Knee mobility
Time Frame: Day 0
Anterior pull test
Day 0
Knee mobility
Time Frame: Week 6
Anterior pull test
Week 6
Knee mobility
Time Frame: Month 3
Anterior pull test
Month 3
Knee mobility
Time Frame: Month 8
Anterior pull test
Month 8
Knee mobility
Time Frame: Year 1
Anterior pull test
Year 1
Knee mobility
Time Frame: Year 2
Anterior pull test
Year 2
Knee mobility
Time Frame: Year 3
Anterior pull test
Year 3
Lateral pivot shift of knee
Time Frame: Day -1
MacIntosh test
Day -1
Lateral pivot shift of knee
Time Frame: Day 0
MacIntosh test
Day 0
Lateral pivot shift of knee
Time Frame: Week 6
MacIntosh test
Week 6
Lateral pivot shift of knee
Time Frame: Month 3
MacIntosh test
Month 3
Lateral pivot shift of knee
Time Frame: Month 8
MacIntosh test
Month 8
Lateral pivot shift of knee
Time Frame: Year 1
MacIntosh test
Year 1
Lateral pivot shift of knee
Time Frame: Year 2
MacIntosh test
Year 2
Lateral pivot shift of knee
Time Frame: Year 3
MacIntosh test
Year 3
Impact of knee pain on daily life
Time Frame: Day -1
Lysholm Knee Scoring Scale
Day -1
Impact of knee pain on daily life
Time Frame: Day 0
Lysholm Knee Scoring Scale
Day 0
Impact of knee pain on daily life
Time Frame: Week 6
Lysholm Knee Scoring Scale
Week 6
Impact of knee pain on daily life
Time Frame: Month 3
Lysholm Knee Scoring Scale
Month 3
Impact of knee pain on daily life
Time Frame: Month 8
Lysholm Knee Scoring Scale
Month 8
Impact of knee pain on daily life
Time Frame: year 1
Lysholm Knee Scoring Scale
year 1
Impact of knee pain on daily life
Time Frame: Year 2
Lysholm Knee Scoring Scale
Year 2
Impact of knee pain on daily life
Time Frame: Year 3
Lysholm Knee Scoring Scale
Year 3
Patient-reported knee problems
Time Frame: Day -1
International Knee Documentation Committee Questionnaire
Day -1
Patient-reported knee problems
Time Frame: Day 0
International Knee Documentation Committee Questionnaire
Day 0
Patient-reported knee problems
Time Frame: Week 6
International Knee Documentation Committee Questionnaire
Week 6
Patient-reported knee problems
Time Frame: Month 3
International Knee Documentation Committee Questionnaire
Month 3
Patient-reported knee problems
Time Frame: Month 8
International Knee Documentation Committee Questionnaire
Month 8
Patient-reported knee problems
Time Frame: Year 1
International Knee Documentation Committee Questionnaire
Year 1
Patient-reported knee problems
Time Frame: Year 2
International Knee Documentation Committee Questionnaire
Year 2
Patient-reported knee problems
Time Frame: Year 3
International Knee Documentation Committee Questionnaire
Year 3
Knee laxity
Time Frame: Day -1
KT-1000 measurement
Day -1
Knee laxity
Time Frame: Day 0
KT-1000 measurement
Day 0
Knee laxity
Time Frame: Week 6
KT-1000 measurement
Week 6
Knee laxity
Time Frame: Month 3
KT-1000 measurement
Month 3
Knee laxity
Time Frame: Month 8
KT-1000 measurement
Month 8
Knee laxity
Time Frame: Year 1
KT-1000 measurement
Year 1
Knee laxity
Time Frame: Year 2
KT-1000 measurement
Year 2
Knee laxity
Time Frame: Year 3
KT-1000 measurement
Year 3
Passive accessory movement of knee
Time Frame: Day -1
Lachman test
Day -1
Passive accessory movement of knee
Time Frame: Day 0
Lachman test
Day 0
Passive accessory movement of knee
Time Frame: Week 6
Lachman test
Week 6
Passive accessory movement of knee
Time Frame: Month 3
Lachman test
Month 3
Passive accessory movement of knee
Time Frame: Month 8
Lachman test
Month 8
Passive accessory movement of knee
Time Frame: Year 1
Lachman test
Year 1
Passive accessory movement of knee
Time Frame: Year 2
Lachman test
Year 2
Passive accessory movement of knee
Time Frame: Year 3
Lachman test
Year 3
Anterior cruciate ligament and posterior capsule integrity
Time Frame: Day -1
Pivot-shift test
Day -1
Anterior cruciate ligament and posterior capsule integrity
Time Frame: Day 0
Pivot-shift test
Day 0
Anterior cruciate ligament and posterior capsule integrity
Time Frame: Week 6
Pivot-shift test
Week 6
Anterior cruciate ligament and posterior capsule integrity
Time Frame: Month 3
Pivot-shift test
Month 3
Anterior cruciate ligament and posterior capsule integrity
Time Frame: Month 8
Pivot-shift test
Month 8
Anterior cruciate ligament and posterior capsule integrity
Time Frame: Year 1
Pivot-shift test
Year 1
Anterior cruciate ligament and posterior capsule integrity
Time Frame: Year 2
Pivot-shift test
Year 2
Anterior cruciate ligament and posterior capsule integrity
Time Frame: Year 3
Pivot-shift test
Year 3
Post-operative complications
Time Frame: Year 3
Undesirable events
Year 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dedienne Sante S.A.S.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Philippe Marchand, MD, CHU Nîmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 17, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 24, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 24, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IDIL/2017/PM-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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