A PMCF-study on bioresorbable mm.IF interference screw for soft tissue fixation at the knee joint

Suspended

• Conditions: Rupture of the posterior oblique ligament (POL)Rupture of the patella tendonRupture of the medial patellofemoral ligament (MPFL)Rupture of the iliotibial band; S83.43; S83.53; S83.44

• Registration Number: DRKS00023965
• Lead Sponsor: Medical Magnesium GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

(1) Patient is capable to give informed consent and agreed to participate in the study .
(2) Patient is at least 18 years of age at the time of enrollment.
(3) Patient requires one of the following primary surgeries: Anterior cruciate ligament (ACL) repair, Medial collateral ligament (MCL) repair, Lateral collateral ligament (LCL) repair, Patellar tendon repair, Posterior oblique ligament (POL) repair, Iliotibial band tenodesis, Medial patellofemoral ligament (MPFL) reconstruction.
(4) Patient must be treated with mm.IF bioresorbable interference screw for soft tissue fixation according to the instructions for use.
(5) Ability and willingness to adhere to study follow-up.

Exclusion Criteria

1) Patient is pregnant or plans to become pregnant during the study, 2) Patient of a vulnerable group: Patients with incurable diseases; Patients in nursing homes; Patients in emergency situations; Homeless, nomads or refugees; Persons who are accommodated in an institution by court or official order, 3) Patient has conditions that may interfere with graft survival or outcome (e.g., osteoarthritis, severe cartilage damage, Paget disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease), 4) Insufficient bone quantity or quality according to the investigator’s assessment, 5) Inadequate circulation, e.g. peripheral arterial disease, 6) Present tumor or infection disease or previous local infection or increased risk of infection, 7) History of ligament or meniscal surgery or fracture on the affected knee, 8) Known allergy to the study device and or any of its components, 9) In the opinion of the investigator, patient has an emotional or neurological condition that would pre-empt their willingness to participate in the study, including mental illness, drug or alcohol abuse, 10) Patient is entered in another investigational drug or device trial (pre-market), or has been treated with an investigational product in the past 30 days, 11) Patient is known to be at risk for loss to follow-up or failure to return for scheduled study visits, 12) Patient is personally dependent on the investigator or the sponsor of the study

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical success of graft fixation up to 6 months after surgery, defined by the absence of additional, unplanned interventions on the graft fixation method on compliant patients.