mpfl reconstruction
ProcedureMedial patellofemoral ligament reconstruction
NCT Number: NCT07564011
Patellofemoral instability (PFI) is a common condition that may result from numerous underlying soft tissue and bony abnormalities, and can significantly impact the patients' quality of life and function. It is estimated that PFI affects between 5.8 and 29 out of every 100,000 children aged 10 to 17 years [1].
Patellar instability is defined as a symptomatic deficiency of the passive constraint such that the patella may escape partially or completely from its anatomic position with respect to the femoral trochlea under the influence of a displacing force. Such a displacing force could be generated by muscle tension, movement, and/or externally applied forces [2].
The etiology of RPD is multifactorial, including medial patellofemoral ligament (MPFL) injuries, abnormally lateralized tibial tubercle (TT), femoral trochlear dysplasia, patella alta, increased femoral anteversion and genu valgum [3,5].
The MPFL is the primary static soft tissue restraint which restrains against lateral subluxation and dislocation of the patella, especially between 0° and 30° of knee flexion [3]. And the MPTL act as secondary restraint[4.]
Therefore, injury or deficiency of MPFL is one of the predisposing factors for RPD.Therefore, an anatomical repair MPFL is necessary to prevent redislocation of patella [6].
MPFL reconstruction is widely recognized as an important component of the current treatment for recurrent patellar instability, MPTL reconstruction improve medial patellar stabilization, patellar tilt, patellar rotation as well as decreases stress on MPFL.A large number of surgical methods for treating patellofemoral instability have been described in various studies, but the best method is still controversial[7].
This study is prepared to compare the results of MPFL reconstruction versus combined MPFL and MPTL reconstruction in management of recurrent lateral patellar dislocation in children .
Trial opening soon.
Get NotifiedUp to 18 year
All sexes
Interventional
Not applicable
Patellofemoral instability (PFI) is a common condition that may result from numerous underlying soft tissue and bony abnormalities, and can significantly impact the patients' quality of life and function. It is estimated that PFI affects between 5.8 and 29 out of every 100,000 children aged 10 to 17 years [1].
Patellar instability is defined as a symptomatic deficiency of the passive constraint such that the patella may escape partially or completely from its anatomic position with respect to the femoral trochlea under the influence of a displacing force. Such a displacing force could be generated by muscle tension, movement, and/or externally applied forces [2].
The etiology of RPD is multifactorial, including medial patellofemoral ligament (MPFL) injuries, abnormally lateralized tibial tubercle (TT), femoral trochlear dysplasia, patella alta, increased femoral anteversion and genu valgum [3,5].
The MPFL is the primary static soft tissue restraint which restrains against lateral subluxation and dislocation of the patella, especially between 0° and 30° of knee flexion [3]. And the MPTL act as secondary restraint[4.]
Therefore, injury or deficiency of MPFL is one of the predisposing factors for RPD.Therefore, an anatomical repair MPFL is necessary to prevent redislocation of patella [6].
MPFL reconstruction is widely recognized as an important component of the current treatment for recurrent patellar instability, MPTL reconstruction improve medial patellar stabilization, patellar tilt, patellar rotation as well as decreases stress on MPFL.A large number of surgical methods for treating patellofemoral instability have been described in various studies, but the best method is still controversial[7].
This study is prepared to compare the results of MPFL reconstruction versus combined MPFL and MPTL reconstruction in management of recurrent lateral patellar dislocation in children .
2.4.1- Type of the study: Randomised controlled trial . 2.4. 2- Study Setting: Arthroscopy Unit, Orthopaedic and trauma Surgery department, Assiut University Hospital, Assiut, Egypt.
2.4. 3- Study subjects: a. Inclusion criteria:
1- Age : <18years old. 2- History of recurrent lateral patellar dislocation (>2 episodes). 3- Failure of conservative treatment.
c. Sample Size Calculation: Based on determining the main outcome variable, the estimated minimum required sample size is 22 pediatric patients (11 patients in each group).
The sample was calculated using G*Power software version 3.1.9.2, based on the following assumption : The main outcome variable is the difference in mean postoperative functional outcome score between children with recurrent lateral patellar dislocation treated with Medial Patellofemoral Ligament (MPFL) reconstruction alone versus those treated with combined MPFL and Medial Patellotibial Ligament (MPTL) reconstruction.
d. Method of Randomization : Computer generated randomization into2 groups (A) : MPFL reconstruction alone and group (B) :combined MPFL and MPTL reconstruction in management of recurrent lateral patellar dislocation in children.
The primary statistical test is an independent samples t-test to detect the difference between the two groups.
Alpha = 0.05 Power = 0.80 Effect size (d) = 1.1
2.4.4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals): All patients meeting the inclusions criteria will be allocated .
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2.4.5 -Research outcome measures:
a. Primary (main): Comparing results of MPFL reconstruction alone versus combined MPFL and MPTL reconstruction in management of recurrent lateral patellar dislocation in children.
Secondary (subsidiary):
Adress risk factors of patellar dislocation & redislocation after surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
a. Inclusion criteria:
Exclusion criteria
b. Exclusion criteria:
Medial patellofemoral ligament reconstruction
Combined medial patellofemoral and mediopatellotibial ligaments reconstruction
Time frame: 12 months post operative
Time frame: 12 month
Time frame: 12 months
Time frame: 12 month
Time frame: 12months
Assiut University
Other
Acronym: MPFL-MPTL
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