To study and evaluate the safety and effectiveness of Foot Plate System
- Conditions
- Health Condition 1: S920- Fracture of calcaneusHealth Condition 2: S923- Fracture of metatarsal bone(s)Health Condition 3: S921- Fracture of talus
- Registration Number
- CTRI/2024/04/065262
- Lead Sponsor
- Auxein Medical Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome: <br/ ><br> Fracture healing [Time Frame: baseline, 1, 3, 6, 12 after surgery] <br/ ><br>evaluated by X-ray images <br/ ><br> ? Quality of foot movement by calculating Manchester foot <br/ ><br>questionnaire score [Time Frame: baseline, 1, 3, 6, 12 after <br/ ><br>surgery] <br/ ><br> ? Complications [Time Frame: baseline, at 1, 3, 6, 12 month post surgery] <br/ ><br> <br/ ><br>Timepoint: Baseline, 1, 3, 6 and 12 months after surgery
- Secondary Outcome Measures
Name Time Method Pain on the affected region using VAS(Visual Analog Scale) <br/ ><br>Timepoint: Baseline, 1, 3, 6 and 12 months after surgery