Rupture of the anterior cruciate ligament (ACL) Rupture of the medial collateral ligament (MCL) Rupture of the lateral collateral ligament (LCL) Rupture of the posterior oblique ligament (POL) Rupture of the patella tendon Rupture of the medial patellofemoral ligament (MPFL) Rupture of the iliotibial band
Conditions
Interventions
Group 1: Patients will be recruited who receive the mm.IF interference screw as part of routine medical care for the treatment of any of the following ruptures at the knee joint according to the manuf
and Tegner, Lysholm, Kujala, and BPII 2.0 for MPFL, respectively) are obtained.
During surgery:
Collecting information on product handling and potential adverse events.
Visit 1:
Three months after
MCL, Valgus stress test
LCL, Varus stress test
POL, Abduction test at 30° flexion and maximum extension
Patellar tendon and MPFL, Patellar Apprehension Test
Iliotibial band , Ober's test. In addition, data on knee range of motion (ROM), PROMs (IKDC, Tegner, and Lysholm for AC
Sponsors
Medical Magnesium GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Number of adverse device effects and serious adverse device effects (ADEs/SADEs) up to 24 months after surgery. (2) Clinical success of the graft fixation method up to 24 months after primary surgery, defined as the absence of additional unplanned interventions required on the graft fixation method on compliant patients. (3) Quality of life before and 6, 12 and 24 months after surgery, assessed by the EQ-5D-5L questionnaire. (4) PROMs before and 6, 12, and 24 months after surgery: Tegner, IKDC, Lysholm for ACL, MCL, LCL, POL, patellar tendon, and ITB, respectively; and Tegner, Lysholm, Kujala, and BPII 2.0 for MPFL. (5) Knee stability at 6, 12, and 24 months after surgery: ACL, Lachman test with Lachmeter; MCL, valgus stress test; LCL, varus stress test; POL, abduction test at 30° flexion and maximum extension; patellar tendon and MPFL, patellar apprehension test; iliotibial band, Ober's test. (6) Knee range of motion at 6, 12, and 24 months after surgery assessed by the normal-zero method. | — |
Countries
Germany
Contacts
Public ContactArndt-Peter Schulz
BG Klinikum Hamburg
Outcome results
None listed