Metaphyseal fractures of the hands, feet and limbs, osteotomy and other non-load-bearing operations
Conditions
Interventions
Experimental group:Magnesium alloy bone screws
Control group:Hollow screw
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-65 years old (inclusive), gender is not limited; (2) Patients confirmed by imaging examination to require metaphyseal fractures of hands, feet and limbs, osteotomy and other non-load-bearing operations; (3) Voluntarily participate in this clinical trial and sign the subject informed consent.
Exclusion criteria
Exclusion criteria: (1) Active phase of systemic infection or active phase of infection at the surgical site, affecting the operation; (2) People in the active period of infectious diseases such as viral hepatitis, acquired immune deficiency syndrome (AIDS), syphilis and tuberculosis; (3) Patients with pathological fracture, osteofascial compartment syndrome, osteomyelitis, severe tissue or vaso-nerve injury, and insufficient bone or bone mass to securely fix the implant; (4) Poor blood glucose control (any blood glucose > 10.0mmol/L), or poor skin/soft tissue status at the implant site; (5) Patients with abnormal blood biochemistry or coagulation function during the screening period were clinically significant (ALT, AST or Cr = 2 times the upper limit of normal, or APTT > 1.5 times the upper limit of normal; (6) previous allergies to magnesium alloy and titanium alloy implant materials; (7) Patients with mental illness, or unable to cooperate with the test procedure for various reasons, or unwilling or unable to restrict their activities; (8) Patients who abuse drugs or alcohol and cannot guarantee to quit smoking during fracture healing; (9) Long-term preoperative (more than 3 months of continuous use) use of drugs that affect bone and soft tissue healing (such as chemotherapy drugs, corticosteroid hormones, except methylprednone); (10) Long-term use of sedative hypnotic drugs or long-term use of non-steroidal anti-inflammatory drugs before surgery (continuous use of more than 3 months); (11) Women who are pregnant or breastfeeding or who plan to become pregnant during the trial; (12) Participants who participated in other clinical trials within 1 month before the start of this trial; (13) 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;Degradation degree of magnesium alloy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Joint function score;Incision recovery; | — |
Countries
china
Contacts
Public ContactZheng Xianyou
Shanghai Sixth People's Hospital
Outcome results
None listed