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The clinical observational study for the treatment of the pure medial malleolus fracture by the new biodegradable magnesium alloy screws

The clinical observational study for the treatment of the pure medial malleolus fracture by the new biodegradable magnesium alloy screws

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INC-16009956
Enrollment
Unknown
Registered
2016-11-22
Start date
2017-01-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pure medial malleolus fracture

Interventions

Trial group:Fix the fracture by magnesium alloy screw
Control:Degradable screw

Sponsors

Ninth People’s Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Citizens aged 18 to 80 years old; 2. Platelets above 50000, blood sugar is not higher than 10.0, the white blood cells no less than 4.0x10^9/L, nutrition is in good condition; 3. Hepatitis A, hepatitis B, hepatitis C, HIV/AIDS, tuberculosis and other infectious diseases are not in the activity stage; 4. Traumatic fractures; 5. Fragility fracture; 6. No implant contraindication; 7. Do not attend any clinical verification within three months; 8. Agreed to participate in the test, understand and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Any active systemic and local infection; 2. General situation is bad, severe malnutrition or cachexia, poor blood sugar control; 3. Pathological fracture; 4. Allergic to the material; 5. Expected to survival period of no more than two years; 6. Not timely follow-up, or for other reasons can't cooperate with researchers; 7. Can not accept the new technology used in this study.

Design outcomes

Primary

MeasureTime frame
Fracture healing time (subject to fracture line disappeared) evaluated by X-ray and CT;Degradation degree of screw (the CT value in screw diameter);

Secondary

MeasureTime frame
Operation time, intraoperative blood transfusion;Intraoperative and postoperative complications;Clinical symptoms caused by fracture progress, whether disappear or get improved significantly after surgery;Limb function score;

Contacts

Public ContactYongqiang Hao

Ninth People's Hospital,Shanhai Jiaotong University School of Medcine

hyq_9hospital@hotmail.com+86 13501969828

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026