M20.1
Conditions
Interventions
Group 1: mm.CS is used during therapeutic open surgical, arthroscopic, or minimally invasive orthopedic and/or trauma surgical procedures according to standard medical procedures and the manufacturer'
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) Preoperative diagnosis of mild or moderate hallux valgus, symptomatic (ICD M20.1), indicated by HVA of 21°-40° and IMA of 8°-20° (4) Inadequate response to conservative treatment and requirement for primary surgical intervention (5) Use of bioabsorbable mm.CS screw for chevron or scarf osteotomy is indicated according to the manufacturer's instructions (6) Ability and willingness to adhere to study follow-up
Exclusion criteria
Exclusion criteria: (1) Patient plans to become pregnant during the study (2) Patient of a vulnerable group: (2.1) Patients with incurable diseases; (2.2) Patients in emergency situations that may impair judgment; (2.3) Patients in nursing homes; (2.4) Patients without fixed abode; (2.5) Patients who are accommodated under deprivation of liberty pursuant to an administrative or court order or permit (3) Known presence of a contraindication to the use of mm.CS according to the manufacturer's instructions for use (4) Present tumor disease or increased risk of infection (5) Known allergy to the study device and or any of its components (6) In the opinion of the investigator, patient has an emotional or neurological condition that would pre-empt their willingness to participate in the study or ability to comply with the study and the recommended rehabilitation, including mental illness, drug, or alcohol abuse (7) Patient is entered in an investigational drug or device trial (pre-market), or has been treated with an investigational product in the past 30 days (8) Patient is known to be at risk for loss to follow-up or failure to return for scheduled study visits (9) Patient is personally dependent on the investigator or the sponsor of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Clinical success up to 3 month after surgery, defined by the absence of pseudarthrosis at the osteotomy site on compliant patients. (2) AOFAS-MTP-IP score prior to and at 3 month after surgery. (3) Pain assessment (VAS) prior to and at 3 month after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Number of the following events up to 24 months post-op: Adverse device effects (ADEs), Serious adverse device effects (SADEs). (2) Technical success of the surgery (3) Radiography of implanted mm.CS before/after surgery and 6 weeks, 3 months, and 12 months post-op according to clinical standard (4) Time to bone consolidation at the osteotomy site, defined by the absence of signs of bone discontinuity 6 weeks and 3 months post-op (5) Functional success 6 weeks, 3 months, and 12 months post-op (6) Clinical success 12 months post-op, defined by the absence of signs of pseudarthrosis at the osteotomy site in patients who follow the physician's instructions (7) AOFAS-MTP-IP score 12 months and 24 months post-op. (8) Foot and Ankle Ability Measure (FAAM) before surgery and 6 weeks, 3 months, 12 months, and 24 months post-op. (9) European Foot & Ankle Society (EFAS) before surgery and 6 weeks, 3 months, 12 months, and 24 months post-op (10) Pain score (VAS) 6 weeks, 12 months, and 24 months post-op (11) SF-36 questionnaire before and at week 6, 3 months, 12 months, and 24 months post-op (12) Patient satisfaction before and at 6 weeks, 3 months, 12 months, and 24 months post-op | — |
Countries
Germany
Contacts
Public ContactChristian Plaaß
Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift
Outcome results
None listed