Health Condition 1: S920- Fracture of calcaneus Health Condition 2: S923- Fracture of metatarsal bone(s) Health Condition 3: S921- Fracture of talus
Conditions
Interventions
Intervention1: Foot Plate System: The foot plate system is used for fixation of foot bones fracture. Duration of intervention will be 1 year.
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Auxein Medical Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient diagnosed with foot fractures, metatarsals fractures, osteotomies, nonunions and complex fractures of the calcaneus. 2. Both male and female above 18 (skeletally mature) to 75 years patients. 3. Patient is willing and able to give informed consent for participation in the study. 4. Patient willing and able to comply with post-operative study follow up.
Exclusion criteria
Exclusion criteria: 1. Any past or present evidence of infection of the treated joint. 2. Signs of any local inflammation. 3. Patient susceptibility to allergic reaction to the components of the alloy, the implant is manufactured from. 4. Mental illness or schizophrenic, which may cause patients to ignore the limitations and precautions of the implanted material, leading to implants fracture and complication. 5. Patients having inadequate tissue coverage over the operative site. 6. Severe osteopenia and/or osteoporosis, or in the presence of marked or rapid bone absorption, metabolic bone disease, cancer, or any other tumor ?like condition of the bone which may compromise fixation. 7. Patient who is pregnant or intends to become pregnant during the study. 8. Any patient unwilling to cooperate with the post ?operative instructions. 9. Any condition or anatomy that makes treatment with the Foot plate system infeasible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome: Fracture healing [Time Frame: baseline, 1, 3, 6, 12 after surgery] evaluated by X-ray images ? Quality of foot movement by calculating Manchester foot questionnaire score [Time Frame: baseline, 1, 3, 6, 12 after surgery] ? Complications [Time Frame: baseline, at 1, 3, 6, 12 month post surgery] Timepoint: Baseline, 1, 3, 6 and 12 months after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain on the affected region using VAS(Visual Analog Scale) Timepoint: Baseline, 1, 3, 6 and 12 months after surgery | — |
Countries
India
Contacts
Public ContactMr Gaurav Luthra
Auxein Medical Pvt. Ltd.
Outcome results
None listed