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.

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.

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03529552

Acronym

BIORELICA

Enrollment

Registered

2018-05-18

Start date

2018-09-17

Completion date

2019-04-24

Last updated

2020-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Rupture

Brief summary

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

Interventions

PROCEDUREAnterior Cruciate Ligament Reconstruction

Placement of an SMS bioresorbable interference screw (DEDIENNE Santé)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
In situ degradation of screw	Year 3	Assessed on T1 and proton density fat saturation MRI

Secondary

Measure	Time frame	Description
Knee mobility	Day -1	Anterior pull test
Lateral pivot shift of knee	Day -1	MacIntosh test
Impact of knee pain on daily life	Day -1	Lysholm Knee Scoring Scale
Patient-reported knee problems	Day -1	International Knee Documentation Committee Questionnaire
Knee stiffness	Day -1	Articular amplitude test
Passive accessory movement of knee	Day -1	Lachman test
Anterior cruciate ligament and posterior capsule integrity	Day -1	Pivot-shift test
Post-operative complications	Year 3	Undesirable events
Knee laxity	Day -1	KT-1000 measurement

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026