Trial Outcomes & Findings for Reduction and Fixation of Metatarsal Neck Fracture by Metaizeau's Technique (NCT NCT05640466)
NCT ID: NCT05640466
Last Updated: 2024-02-23
Results Overview
Time taken from operation till full fracture union
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
8 weeks postoperatively
Results posted on
2024-02-23
Participant Flow
All participants came to sohag university hospital
no participant excluded
Participant milestones
| Measure |
Adult Patient With Displaced Metatarsal Head Fractures
A Kirschner wire with its distal end is placed showing a small bend into the medullar cavity through the lateral margin of the proximal metaphysis of the affected metatarsal using a 5mm skin incision at that level. The skin incision was made over the interosseus space, so as to use one incision for the two neighbouring metatarsal bones. The diameter of the Kirschner wires to be used should be related to the size of the fractured metatarsal medullar cavity. Kirschner wire will be driven anterograde, with the help of an X-ray image intensifier.
Subsequently, the wire will be rotated 180 to direct its end to the dorsum of the foot so as to provoke a translation effect on the metatarsal head in order to obtain the head reduction, and maintained this reduction with the Kirschner wire.
Reduction and fixation of metatarsal neck fracture by metaizeau's technique: Reduction and fixation of metatarsal neck fracture by metaizeau's technique
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Adult Patient With Displaced Metatarsal Head Fractures
n=20 Participants
A Kirschner wire with its distal end is placed showing a small bend into the medullar cavity through the lateral margin of the proximal metaphysis of the affected metatarsal using a 5mm skin incision at that level. The skin incision was made over the interosseus space, so as to use one incision for the two neighbouring metatarsal bones. The diameter of the Kirschner wires to be used should be related to the size of the fractured metatarsal medullar cavity. Kirschner wire will be driven anterograde, with the help of an X-ray image intensifier.
Subsequently, the wire will be rotated 180 to direct its end to the dorsum of the foot so as to provoke a translation effect on the metatarsal head in order to obtain the head reduction, and maintained this reduction with the Kirschner wire.
Reduction and fixation of metatarsal neck fracture by metaizeau's technique: Reduction and fixation of metatarsal neck fracture by metaizeau's technique
|
|---|---|
|
Age, Continuous
|
27.1 years
STANDARD_DEVIATION 12.11 • n=20 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
20 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
Egypt
|
20 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 8 weeks postoperativelyTime taken from operation till full fracture union
Outcome measures
| Measure |
Adult Patient With Displaced Metatarsal Head Fractures
n=20 Participants
A Kirschner wire with its distal end is placed showing a small bend into the medullar cavity through the lateral margin of the proximal metaphysis of the affected metatarsal using a 5mm skin incision at that level. The skin incision was made over the interosseus space, so as to use one incision for the two neighbouring metatarsal bones. The diameter of the Kirschner wires to be used should be related to the size of the fractured metatarsal medullar cavity. Kirschner wire will be driven anterograde, with the help of an X-ray image intensifier.
Subsequently, the wire will be rotated 180 to direct its end to the dorsum of the foot so as to provoke a translation effect on the metatarsal head in order to obtain the head reduction, and maintained this reduction with the Kirschner wire.
Reduction and fixation of metatarsal neck fracture by metaizeau's technique: Reduction and fixation of metatarsal neck fracture by metaizeau's technique
|
|---|---|
|
Time of Union
|
5.8 weeks
Standard Deviation 1.48
|
PRIMARY outcome
Timeframe: 8 weeks post-operativelyTime taken from operation till starting range of motion (ROM)
Outcome measures
| Measure |
Adult Patient With Displaced Metatarsal Head Fractures
n=20 Participants
A Kirschner wire with its distal end is placed showing a small bend into the medullar cavity through the lateral margin of the proximal metaphysis of the affected metatarsal using a 5mm skin incision at that level. The skin incision was made over the interosseus space, so as to use one incision for the two neighbouring metatarsal bones. The diameter of the Kirschner wires to be used should be related to the size of the fractured metatarsal medullar cavity. Kirschner wire will be driven anterograde, with the help of an X-ray image intensifier.
Subsequently, the wire will be rotated 180 to direct its end to the dorsum of the foot so as to provoke a translation effect on the metatarsal head in order to obtain the head reduction, and maintained this reduction with the Kirschner wire.
Reduction and fixation of metatarsal neck fracture by metaizeau's technique: Reduction and fixation of metatarsal neck fracture by metaizeau's technique
|
|---|---|
|
Time to Range of Motion (ROM) Start
|
3.5 weeks
Standard Deviation 0.51
|
Adverse Events
Adult Patient With Displaced Metatarsal Head Fractures
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adult Patient With Displaced Metatarsal Head Fractures
n=20 participants at risk
A Kirschner wire with its distal end is placed showing a small bend into the medullar cavity through the lateral margin of the proximal metaphysis of the affected metatarsal using a 5mm skin incision at that level. The skin incision was made over the interosseus space, so as to use one incision for the two neighbouring metatarsal bones. The diameter of the Kirschner wires to be used should be related to the size of the fractured metatarsal medullar cavity. Kirschner wire will be driven anterograde, with the help of an X-ray image intensifier.
Subsequently, the wire will be rotated 180 to direct its end to the dorsum of the foot so as to provoke a translation effect on the metatarsal head in order to obtain the head reduction, and maintained this reduction with the Kirschner wire.
Reduction and fixation of metatarsal neck fracture by metaizeau's technique: Reduction and fixation of metatarsal neck fracture by metaizeau's technique
|
|---|---|
|
Musculoskeletal and connective tissue disorders
stifness foot
|
5.0%
1/20 • Number of events 1 • 4 months postoperative
|
Other adverse events
| Measure |
Adult Patient With Displaced Metatarsal Head Fractures
n=20 participants at risk
A Kirschner wire with its distal end is placed showing a small bend into the medullar cavity through the lateral margin of the proximal metaphysis of the affected metatarsal using a 5mm skin incision at that level. The skin incision was made over the interosseus space, so as to use one incision for the two neighbouring metatarsal bones. The diameter of the Kirschner wires to be used should be related to the size of the fractured metatarsal medullar cavity. Kirschner wire will be driven anterograde, with the help of an X-ray image intensifier.
Subsequently, the wire will be rotated 180 to direct its end to the dorsum of the foot so as to provoke a translation effect on the metatarsal head in order to obtain the head reduction, and maintained this reduction with the Kirschner wire.
Reduction and fixation of metatarsal neck fracture by metaizeau's technique: Reduction and fixation of metatarsal neck fracture by metaizeau's technique
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Bone infection
|
0.00%
0/20 • 4 months postoperative
|
Additional Information
Hussien Sedik Mohamed, Orthopedic Surgery Resident, Sohag University
Sohag University
Phone: +20-1065840049
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place