M20.4 M20.5
Conditions
Interventions
Group 1: • Pre-surgery: Physical examination (height, weight and organ systems)
patient satisfaction assessed using a Likert scale
pain assessed using the VAS score and a Likert scale
American Orthopaedic Foot & Ankle Society (AOFAS-LMIS) score
photo documentation
• Surgery: Assessment of technical success of surgery, photo documentation, and recording of potential adverse events
• Visit 1: 6 weeks after surgery, data on patient satisfaction (Likert scale), pain (VAS score and Likert scale), and the AOFAS-LMIS score are collected. The clinical success of joint arthrodesis is a
Sponsors
Medical Magnesium GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Patient is able to give and provided informed consent for study participation • Patient requires surgical correction of hammer or claw toes either isolated or in conjunction with distal Hallux valgus surgery • Ability and willingness to adhere to study follow-up
Exclusion criteria
Exclusion criteria: • Contraindications for mm.PIP as indicated in the instructions for use • Patient of a vulnerable group: Patients with incurable diseases; Patients in nursing homes; Patients in emergency situations; Homeless, nomads or refugees; • Dislocation of the metatarsophalangeal joint (MTP joint) • Complex regional pain syndrome • Known allergy to the study device and or any of its components • Fracture or deformities of accompanying bones (e.g. metatarsal bones) • 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 • Patient is entered in another investigational drug or device study, or has been treated with an investigational product in the past 30 days • Patient is suffering from restricted mobility that may impair post-operative healing • Patient is known to be at risk for loss to follow-up or failure to return for scheduled study visits • Patient is personally dependent on the investigator or the sponsor of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success of the joint fusion method up to 6 weeks after surgery, defined by the maintenance of implant integrity and the exclusion of bone end dislocation. Radiological assessment is carried out according to clinical standard. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Number of ADEs/SADEs up to 6 weeks, 6 months and 12 months after surgery • Clinical success of the joint fusion method up to 6 months and 12 months after surgery, defined by the absence of signs of pseudarthrosis. • Technical success of surgery, defined as: Successful implantation; No damage of implant; No loss of integrity; No exchange of the implant required; • Patient satisfaction, assessed by a Likert scale prior to and at 6 weeks, 6 months and 12 months after surgery • Pain, assessed by VAS and Likert scale prior to and at 6 weeks, 6 months and 12 months after surgery • AOFAS-LMIS score prior to and at 6 weeks, 6 months and 12 months after surgery • Photo documentation prior, during and at 6 weeks, 6 months and 12 months after surgery | — |
Countries
Germany
Contacts
Public ContactRené Burchard
Lahn-Dill-Kliniken, Klinik für Orthopädie & Unfallchirurgie
Outcome results
None listed