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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04072094
Other study ID # z2gk
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2020
Est. completion date June 2025

Study information

Verified date August 2019
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Zhao-ming Ye, MD
Phone +86-571-87783553
Email 2192002@zju.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The best treatment for the open tibia fractures remains controversial. It is unknown whether minimally invasive locking plate or reamed intramedullary nail fixation will result in lower complication rates and better function.


Description:

The best fixation method for open tibial fractures remains controversial. The current standard treatment options recommended the use of intramedullary nail for treating such fractures. Recent studies also showed favorable results for the use of plates in managing open tibial fractures. However, it is unknown whether locking plate or intramedullary nail fixation will result in lower complication rates and better function.

This study is a prospective, randomized trial to compare the safety and efficiency of minimally invasive plate osteosynthesis and reamed intramedullary nails in treating type I-II open tibial shaft fractures. The investigators hypothesize that neither intervention resulted in a superior disability rating at 12 months. Outcomes evaluated will include the rate of infection, the number of re-hospitalization for the complication, the time to bone healing, Patient-Reported outcome and quality of life and other complications.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date June 2025
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Ages 18 - 60 years inclusive

- Open diaphyseal fracture

- Gustilo-Anderson Type I, II, IIIA

Exclusion Criteria:

- Closed, periarticular or pathological fracture

- Gustilo-Anderson Type IIIB,IIIC

- Patients with concomitant fractures in the ipsilateral limb

- The patient is unable to medically tolerate general anesthesia

- The patient is unable to provide informed consent or comply with completing questionnaires

- Tibia already infected as diagnosed by a surgeon

- The patient has been diagnosed with a severe psychiatric condition

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Minimally Invasive Locking Plate Fixation
Patients randomized to the Minimally Invasive Locking Plate Fixation arm will be treated with plate fixation. The plate may be applied in a percutaneous fashion. Any combination of locked and/or non-locked screws may be used.
Intramedullary Nail Fixation
Patients randomized to the Intramedullary Nail Fixation arm will be receive a standard locked intramedullary nail fixation. The nail must use at least one static interlock proximal to and one static interlock distal to the fracture site. The nail may be placed with a reamed technique.

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University First People's Hospital Affiliated to Huzhou University, Ningbo No.2 Hospital, Taizhou Hospital

Outcome

Type Measure Description Time frame Safety issue
Other SF-12 Reported Outcome and Quality of Life 12 months
Other Fracture Healing Fracture healing is measured by the treating surgeon using standard clinical criteria. 12 months
Other Complications Soft tissue complications 12 months
Primary LEFS failure. 12 months
Secondary EQ-5D Reported Outcome and Quality of Life 12 months
See also
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Not yet recruiting NCT05766670 - Intramedullary Calcium Sulfate Antibiotic Depot Phase 3
Completed NCT02064595 - Open Tibia Fractures a Comparative Study Between Biplane External Fixator and Locked Intramedullary Nail N/A