An MR imaging study on bioresorbable mm.IF interference screw for graft fixation in ACL repair
- Conditions
- S83.53
- Registration Number
- DRKS00023966
- Lead Sponsor
- Medical Magnesium GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting withdrawn before recruiting started
- Sex
- All
- Target Recruitment
- 15
(1) Patient is at least 18 years of age at the time of enrollment.
(2) Patient requires surgical reconstruction of the anterior cruciate ligament (ACL).
(3) Patient must be treated with mm.IF bioresobable interference screw for soft tissue fixation according to the manufacturers instructions for use
(4) Ability and willingness to adhere to study follow-up.
(5) Patient is able to give informed consent for study participation.
(1) Patient is a minor or incapable of giving informed consent
(2) Patient is pregnant or plans to become pregnant during the study
(3) Patient of a vulnerable group (Patients with incurable diseases, Patients in nursing homes, Patients in emergency situations, Homeless, nomads or refugees, Patients who are accommodated under deprivation of liberty pursuant to an administrative or court order or permit)
(4) Contraindications for the use of mm.IF interference screw according to the manufacturer's instructions
(5) History of ligament or meniscal injury or fracture of the affected knee
(6) Present tumor or infectious disease or previous local infection or increased risk of infection
(7) In the opinion of the investigator, patient has an emotional or neurological condition that would pre-empt the willingness to participate in the study, including mental illness, drug, or alcohol abuse
(8) Patient is entered in another investigational drug or device study, or has been treated with an investigational product in the past 30 days
(9) Patient is known to be at risk for loss to follow-up or failure to return for scheduled study visits
(10) Patient is personally dependent on the investigator or the sponsor of the study
Additional MR specific contraindications:
(11) Patient carries one of the following implants: Cardiac pacemaker, Defibrillator (ICD), Left Ventricular Assistant Device (LVAD), Cochlea implant, Neurostimulator, Insulin or analgesic pump, Coronary artery implant, Corpus cavernosum implant, Bladder pacemaker, MRI incompatible heart valve replacement
(12) Metal shards in close proximity to eyes, brain and/or near vessel
(13) Metallic trans- or subdermal jewelry implants
(14) Large tattoos made of dyes with metallic contents
(15) Magnetically fixed denture
(16) Vascular stent implanted less than 72 hours ago
(17) Metallic joint prosthesis or other metal implants for bone stabilization implanted less than 6 weeks ago
(18) Acute myocardial infarction
(19)Claustrophobia
(20) MRI examinations are burdensome due to age or individual constitution
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MR imaging of implanted mm.IF between week 6 and 12 as well as 6, 12, 18 and 24 months after surgery.
- Secondary Outcome Measures
Name Time Method (1) Clinical success of the graft fixation method up to 6, 12, 18 and 24 months after surgery, defined by the absence of additional unplanned interventions to restore graft fixation on compliant patients. <br>(2) Number of adverse or serious adverse product effects (ADEs/SADEs) up to 24 months after surgery.<br>(3) EQ-5D-5L questionnaire prior to and at 6, 12, 18, and 24 months after primary surgery.<br>(4) PROMs before and 6, 12, 18 and 24 months after surgery: International Knee Documentation Committee Score (IKDC), <br>Knee Injury and Osteoarthritis Outcome Score (KOOS), Tegner Activity Scale, Lysholm Score.<br>(5) Lachman Test to assess knee laxity and graft fixation at 6, 12, 18 and 24 moths after primary surgery using Lachmeter, if available.<br>(6) Knee range of motion prior to and at 6, 12, 18 and 24 months after primary surgery.