All MAGNEZIX® implants with marketing approval. Conditions strictly follow the instructions for use (IFU)
Conditions
Interventions
Group 1: Systematic gathering, recording and analysis of application data on the quality, performance, including function and safety and function of MAGNEZIX® when used in the intended area of applica
Sponsors
Syntellix AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Indication for treatment with MAGNEZIX® product according to the IFU. - Age = 18 years. - Written informed consent for all individual patient data entered into the database.
Exclusion criteria
Exclusion criteria: - Exclusion according to the IFU. - Known allergies against any components of the implant. - Participation in an interventional orthopedic or surgical trial prior to surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: - Adverse device effect (ADE) during surgery. - ADE during wound healing, e.g., infection, screw fracture or delayed wound healing. - Revision surgery up to 1-year follow-up postoperatively. - ADE, such as implant-related complication up to 5 years follow-up. - Serious adverse event (SAE) up to 1-year follow-up. - Serious adverse device effect (SADE) up to 5 years follow-up. - Unanticipated SADE (USADE) up to 5 years follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality and performance: - Surgery conducted as intended. - Reasons for deviation. - Implant placed as intended. - Reasons for deviation. - Success of surgery immediately post-operatively. - Function scores, possibly together with their categorizations, for specific indications, such as but not limited to anterior cruciate ligament replacement or arthrodesis of the lesser toes, pre-surgery, if possible, and during follow-up. For example: o Lower extremity function score (LEFS), o Knee and Osteoarthritis Outcome Score (KOOS4) in case of knee surgery, o Score of the European Foot and Ankle Society (EFAS), o Quick Disabilities of the Arm, Shoulder and Hand (q-DASH) questionnaire for hand, arm or shoulder surgeries. All function questionnaires will be used in their validated country-specific language version preoperatively, if possible, and during postoperative follow-up. - Quality of life, as measured with the EQ-5D in its validated country-specific language version preoperatively and during postoperative follow-up. | — |
Countries
Germany, India
Contacts
Public ContactInga-Maria Wefel
Syntellix AG
Outcome results
None listed