- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07564011
Comparison Between Medial Patellofemoral Ligament Reconstruction Alone Versus Combined MPFL & Medial Patellotibial Ligament Reconstruction in the Management of Recurrent Lateral Patellar Dislocation in Children (MPFL-MPTL)
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 .
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
b. Exclusion criteria:
- Active infection.
- inflammatory joint disorders.
- trochlear dysplasia
previous surgeries related to patella dislocation.
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 .
- History taking including :-
- Thorough history evaluation (patient data) including name, age, sex, telephone number, address and comorbidties .
- Complaint and its duration (pain , swelling , deformity, instability ).
Medical history and previous operations.
- Clinical evaluation and apropriate examination :-
- General examination.
knee and patellar examination including :-
- Inspection of the patients knee , deformity , odema and ROM ( range of motion ).
- Look ( skin discoloration, scar, ulcer, signs of infection ).
- Feel ( tenderness and apprehension test ).
- Move ( starting with active movement followed by passive movement ( compare both sides ) to assesROM (range of motion ) and place of patella during flexion and extension.
Asses ( other knee ligaments laxity , tear or generalized joint laxity) - Functional assessment by clinical scores. Kujala Lysholm IKDC - Radiological assessment: Plain x-rays ( AP, lateral and axial views) To measure Insall-Salvati Ratio Caton-Duchamp's Ratio Patella-Plateau Angle Rotational profile MSCT. (To measure TT-TG and rotational malalignment of the femur and tibia(
- Anathesia : according to situation either spinal or general.
- Surgical technique :Medial parapatellar approach
- Medial Patellofemoral Ligament (MPFL) Reconstruction Reconstruction of the medial patellofemoral ligament was performed using the superficial middle portion of the quadriceps tendon as an autograft. The graft length was harvested to be approximately 1 inch longer than the measured distance between the medial border of the patella and the adductor tubercle. A soft-tissue canal was created along the native course of the MPFL, allowing passage of the graft without bone tunnels. And at 30° flexion, the femoral end of the graft was secured to the adductor magnus tendon and reinforced by suturing to the periosteum over the adductor tubercle using non-absorbable sutures, thereby reproducing the anatomical attachment of the native MPFL.
Medial Patellotibial Ligament (MPTL) Reconstruction Reconstruction of the medial patellotibial ligament was carried out using the medial portion of the patellar tendon. And at 90° flexion, the graft was fixed in a subperiosteal fashion approximately 1.5 cm distal to the tibial plateau, oriented at an angle of 25° medially, to replicate the native anatomical direction of the MPTL. Fixation was performed using non-absorbable sutures, ensuring stable graft positioning while preserving the physis Finally,the wound is closed in layers.
- Follow-up schedule : 2 weeks for removal stitches. B) 3 months : Follow up by x-ray and clinical scores. C) 6 months : follow up by x- ray and clincal scores D)12 months : follow up by x-ray, clinical scores and Rotational profile MSCT .
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:a. Inclusion criteria:
- Age : <18years old.
- History of recurrent lateral patellar dislocation (>2 episodes).
- Failure of conservative treatment. -
Exclusion Criteria: b. Exclusion criteria:
- Active infection.
- inflammatory joint disorders.
- trochlear dysplasia
- previous surgeries related to patella dislocation -
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: MPFL Reconstruction For Recurrent patellar displacement in children
MPFL reconstruction
|
Medial patellofemoral ligament reconstruction
|
|
Experimentální: Combined MPFL and MPTL for Recurrent patellar displacement in children
MPFL +MPTL Reconstruction
|
Combined medial patellofemoral and mediopatellotibial ligaments reconstruction
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Kujala Score for knee function
Časové okno: 12 months post operative
|
12 months post operative
|
|
Lysholm score for knee function
Časové okno: 12 month
|
12 month
|
|
Redislocation rate
Časové okno: 12 months
|
12 months
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Range of motion
Časové okno: 12 month
|
12 month
|
|
Complications
Časové okno: 12months
|
12months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
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Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- MPFL-MPTL-2026-1
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Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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