Ignite Creation Date:
2024-07-17 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500325
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
Results of Retrograde Titanium Elastic Nails for Fixation of Proximal Third Tibial Shaft Fractures in Children
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
Results of Retrograde Titanium Elastic Nails for Fixation of Proximal Third Tibial Shaft Fractures in Children
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pediatric tibial shaft fracture is the third most common pediatric long bone fracture after fracture of femur and forearm representing 15 of all pediatric fractures Closed reduction and casting is the standard of care for stable and minimally displaced fracture of the tibia in pediatric age group Treatment of pediatric fractures dramatically changed in 1982 The goals are to stabilize the fracture control limb length alignment rotation instability promote bone healing and minimize the morbidity and complications for the child and hisher family Titanium elastic nails TENs fixation was originally meant as an ideal treatment method for femoral shaft fractures but was gradually applied to other long bones diaphysial fractures in children as it represents a compromise between conservative and surgical therapeutic approaches with satisfactory results and minimal complications
Over the past 20 years pediatric orthopedic surgeons have tried a variety of methods to treat pediatric lower limb fractures to avoid prolonged immobilization and complications Each method has had its own complications cast immobilization alone or following traction had resulted in limb-length discrepancy angulations rotational deformity psychological and economic complications External fixation had resulted in pin-tract infection loss of knee range of motion delayed union non-union and refracture after fixator removal TENs work by balancing the forces between the two opposing flexible implants To achieve this balance the nail diameter should be 40 of the narrowest canal diameter or more The nails should assume a double-C construct They should have similar smooth curve and same level entry points
Ligier et al and Flynn et al have reported that TENs can give rotational stability if good care is taken intra-operatively during nail insertion and postoperatively especially for comminuted spiral and long oblique fractures
Over the past 20 years pediatric orthopedic surgeons have tried a variety of methods to treat pediatric lower limb fractures to avoid prolonged immobilization and complications Each method has had its own complications cast immobilization alone or following traction had resulted in limb-length discrepancy angulations rotational deformity psychological and economic complications External fixation had resulted in pin-tract infection loss of knee range of motion delayed union non-union and refracture after fixator removal TENs work by balancing the forces between the two opposing flexible implants To achieve this balance the nail diameter should be 40 of the narrowest canal diameter or more The nails should assume a double-C construct They should have similar smooth curve and same level entry points
Ligier et al and Flynn et al have reported that TENs can give rotational stability if good care is taken intra-operatively during nail insertion and postoperatively especially for comminuted spiral and long oblique fractures
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None