A PMCF-study on bioresorbable mm.CS compression screws used for the treatment of hallux valgus
- Conditions
- M20.1Hallux valgus (acquired)
- Registration Number
- DRKS00027367
- Lead Sponsor
- Medical Magnesium GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 70
(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
(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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (1) Clinical success up to 3 month after surgery, defined by the absence of pseudarthrosis at the osteotomy site on compliant patients.<br>(2) AOFAS-MTP-IP score prior to and at 3 month after surgery.<br>(3) Pain assessment (VAS) prior to and at 3 month after surgery.<br>
- Secondary Outcome Measures
Name Time Method