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Recurrent Patellar DisplacementMPFL-MPTLNCT07564011

Comparison Between Medial Patellofemoral Ligament Reconstruction Alone Versus Combined MPFL & Medial Patellotibial Ligament Reconstruction in the Management of Recurrent Lateral Patellar Dislocation in Children

A study testing MPFL Reconstruction and MPFL + MPTL Reconstruction in people with Recurrent Patellar Displacement and MPFL, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

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]. Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Recurrent Patellar Displacement, MPFL
What is being tested?
MPFL Reconstruction and MPFL + MPTL Reconstruction
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
No sites listed yet
Study dates
17 Jun 2026to 17 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Age : <18years old.
  • History of recurrent lateral patellar dislocation (>2 episodes).
  • Failure of conservative treatment. -

Who cannot join

  • Active infection.
  • inflammatory joint disorders.
  • trochlear dysplasia
  • previous surgeries related to patella dislocation -

About this study

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].

Read more

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 .

Read the detailed description

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:
  1. Active infection.
  2. inflammatory joint disorders.
  3. trochlear dysplasia
  4. previous surgeries related to patella dislocation.
  5. 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.
  6. 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 :-
  1. Thorough history evaluation (patient data) including name, age, sex, telephone number, address and comorbidties .
  2. Complaint and its duration (pain , swelling , deformity, instability ).
  3. Medical history and previous operations.
  • Clinical evaluation and apropriate examination :- <!-- -->
  1. General examination.
  2. 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:
  1. 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.
Being tested
MPFL Reconstruction, MPFL + MPTL Reconstruction
Keywords
MPFL reconstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MPFL ReconstructionProcedure or surgery

    Medial patellofemoral ligament reconstruction

  • MPFL + MPTL ReconstructionProcedure or surgery

    Combined medial patellofemoral and mediopatellotibial ligaments reconstruction

Study groups in NCT07564011
Study groupRoleWhat they receive
MPFL Reconstruction For Recurrent patellar displacement in childrenExperimentalMPFL reconstruction
Receives: Procedure: MPFL Reconstruction
Combined MPFL and MPTL for Recurrent patellar displacement in childrenExperimentalMPFL +MPTL Reconstruction
Receives: Procedure: MPFL + MPTL Reconstruction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Kujala Score for knee function

    Measured: 12 months post operative

  2. Lysholm score for knee function

    Measured: 12 month

  3. Redislocation rate

    Measured: 12 months

Secondary outcomes (2)
  1. Range of motion

    Measured: 12 month

  2. Complications

    Measured: 12months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2026
  2. Study start17 Jun 2026 (estimated)
  3. Primary completion17 Mar 2028 (estimated)
  4. Study completion17 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07564011
Sponsor's protocol ID
MPFL-MPTL-2026-1
Acronym
MPFL-MPTL
Status last verified
Apr 2026
First submitted
19 Apr 2026
Last updated
8 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Li YJ, Tang DX, Yan HT, Yang B, Yang Z, Long FX. Network pharmacology and molecular docking-based analyses to predict the potential mechanism of Huangqin decoction in treating colorectal cancer. World J Clin Cases. 2023 Jul 6;11(19):4553-4566. doi: 10.12998/wjcc.v11.i19.4553.

    PubMed 37469733
  • Mueller K, Syed HR, Rhee JW, Nair MN. Delayed Chyle Leak Following Anterior Cervical Spinal Surgery: A Case Report and Management Algorithm. Cureus. 2017 May 9;9(5):e1231. doi: 10.7759/cureus.1231.

    PubMed 28620562
  • Fu B, Shen J, Chen Y, Wu Y, Zhang H, Liu H, Huang W. Narrative review of gene modification: applications in three-dimensional (3D) bioprinting. Ann Transl Med. 2021 Oct;9(19):1502. doi: 10.21037/atm-21-2854.

    PubMed 34805364
  • Felli L, Alessio-Mazzola M, Lovisolo S, Capello AG, Formica M, Maffulli N. Anatomy and biomechanics of the medial patellotibial ligament: A systematic review. Surgeon. 2021 Oct;19(5):e168-e174. doi: 10.1016/j.surge.2020.09.005. Epub 2020 Oct 26.

    PubMed 33121878
  • Ng KT, Ng LJ, Oong XY, Chook JB, Chan KG, Takebe Y, Kamarulzaman A, Tee KK. Application of a VP4/VP2-inferred transmission clusters in estimating the impact of interventions on rhinovirus transmission. Virol J. 2022 Mar 4;19(1):36. doi: 10.1186/s12985-022-01762-w.

    PubMed 35246187
  • Bere E, Lahbib K, Merceron B, Fleurat-Lessard P, Boughanmi NG. alpha-TIP aquaporin distribution and size tonoplast variation in storage cells of Vicia faba cotyledons at seed maturation and germination stages. J Plant Physiol. 2017 Sep;216:145-151. doi: 10.1016/j.jplph.2017.04.019. Epub 2017 Jun 1.

    PubMed 28641151
  • Dejour DH, Mesnard G, Giovannetti de Sanctis E. Updated treatment guidelines for patellar instability: "un menu a la carte". J Exp Orthop. 2021 Nov 26;8(1):109. doi: 10.1186/s40634-021-00430-2. No abstract available.

    PubMed 34837157

Questions about this trial

What is this clinical trial studying?

A study testing MPFL Reconstruction and MPFL + MPTL Reconstruction in people with Recurrent Patellar Displacement and MPFL, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kujala Score for knee function (time frame: 12 months post operative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07564011, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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