Foot and ankle fractures or osteotomy internal fixation
Conditions
Interventions
Experimental group:Degradable Mg alloy bone screw
Control group:Absorbable bone screw
Sponsors
Shanghai Ninth Peope's Hospital,Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-80 years old (inclusive), gender is not limited; (2) Confirmed by imaging examination, the foot and ankle should be subjected to fracture reduction and internal fixation or osteotomy orthopedic internal fixation; (3) Be able to read, understand and sign the informed consent, and voluntarily participate in the clinical trial.
Exclusion criteria
Exclusion criteria: (1) Active period of systemic infection, or active period of infection at the surgical site; (2) in viral hepatitis, acquired immune deficiency syndrome (AIDS), syphilis, tuberculosis and other infectious diseases are active; (3) Pathological fracture, osteofascial compartment syndrome, osteomyelitis, open fracture, severe tissue or neurovascular damage, history of severe osteoporosis, bone mass or bone mass not sufficient to secure the implant securely or is intended to be used without traditional rigid fixation, fractures in high-bearing areas (such as long shaft fractures); (4) Users to be combined with other internal implants at the test site; (5) Diabetes mellitus with unstable normal blood glucose control (fasting blood glucose during screening period > 9.0mmol/L), poor skin/soft tissue status at the implant site, or lower limb ischemia. Sexual diseases (such as lower extremity arteriosclerosis obliterans, etc.); (6) Patients with abnormal blood biochemistry or coagulation function during screening period had clinical significance (ALT, AST or Cr = 2 times the upper limit of normal, or APTT > 1.5 times the upper limit of normal; (7) previous allergy to magnesium, neodymium, zirconium, zinc or polylactic acid implant materials; (8) Patients with mental illness, or for various reasons, are unable to cooperate with the test process, or are unwilling to or unable to restrict their activities; (9) Alcohol/nicotine abuse and failure to quit smoking during fracture healing, drug abuse or long-term use of non-steroidal anti-inflammatory agents; (10) Women who are pregnant or breastfeeding or women of childbearing age who plan to become pregnant during the trial; (11) Participants who participated in other interventional clinical trials within 1 month before the start of this trial; (12) Participants who are considered inappropriate by the investigator to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical healing rate of fracture at 24 weeks after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical healing rate of fractures at 12 weeks and 48 weeks after surgery;Degree of degradation; Pain score;Joint function score;Instrument performance index; | — |
Countries
China
Contacts
Public ContactYongqiang Hao
Shanghai Ninth Peope's Hospital,Shanghai Jiao Tong University School of Medicine
Outcome results
None listed