Back to resultsEvaluate Clinical and Radiological Outcomes After Limb Reconstruction Using Monorail Fixator Over Intramedullary Nailing in Tibial Open Fractures With Bone Loss
Primary Purpose
Open Fracture Tibia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intramedullary nail with Limb Reconstruction System
Sponsored by
About this trial
This is an interventional treatment trial for Open Fracture Tibia
Eligibility Criteria
Inclusion Criteria:
- Age from 18-60 years old.
- Open Grade II, Open Grade III (a & b) diaphyseal fractures of Tibia (judged after primary and/or secondary to debridement).
- Bone defect < 10 cm.
- Patients with Injury severity score (ISS) < 17.
Exclusion Criteria:
- Massive bone defect > 10 cm.
- Patients with ISS > 17, polytrauma patient.
- Age < 18 years old or > 60 years old.
- Associated vascular injury ischemic limb.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Participants
Arm Description
patients undergoes intramedullary nail with Limb Reconstruction System
Outcomes
Primary Outcome Measures
ASAMI Scoring System
excellent : active , no limping good : active with one or more of : limp , stiffness , significant pain Fair : active with at least three of the following : limping , stiffness , significant pain , reflex sympathetic syndrome Poor : Inactive Failures : Amputations
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05296785
Brief Title
Evaluate Clinical and Radiological Outcomes After Limb Reconstruction Using Monorail Fixator Over Intramedullary Nailing in Tibial Open Fractures With Bone Loss
Official Title
Management of Open Tibial Fractures With Bone Loss Using Monorail Fixator Over Intramedullary Nail
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2022 (Anticipated)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Road traffic accidents (RTA) is the most common cause of open fractures of long bones, increase in RTA leading to increase of complex non-unions incidence. the Participants are usually undergoing multiple surgeries for healing or to eradicate infection, which in turn leading to loss of bone and soft tissues and require skin grafting, muscle pedicle graft or bone grafting. Sometimes the Participants end up with deformity, limb length discrepancy, joints stiffness, disuse osteoporosis and muscle atrophy after management
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Fracture Tibia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants
Arm Type
Other
Arm Description
patients undergoes intramedullary nail with Limb Reconstruction System
Intervention Type
Procedure
Intervention Name(s)
intramedullary nail with Limb Reconstruction System
Intervention Description
bone transport by Limb Reconstruction System over intramedullary nail on fracture tibia
Primary Outcome Measure Information:
Title
ASAMI Scoring System
Description
excellent : active , no limping good : active with one or more of : limp , stiffness , significant pain Fair : active with at least three of the following : limping , stiffness , significant pain , reflex sympathetic syndrome Poor : Inactive Failures : Amputations
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age from 18-60 years old.
Open Grade II, Open Grade III (a & b) diaphyseal fractures of Tibia (judged after primary and/or secondary to debridement).
Bone defect < 10 cm.
Patients with Injury severity score (ISS) < 17.
Exclusion Criteria:
Massive bone defect > 10 cm.
Patients with ISS > 17, polytrauma patient.
Age < 18 years old or > 60 years old.
Associated vascular injury ischemic limb.
12. IPD Sharing Statement
Learn more about this trial
Evaluate Clinical and Radiological Outcomes After Limb Reconstruction Using Monorail Fixator Over Intramedullary Nailing in Tibial Open Fractures With Bone Loss
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