NCT07564011

Brief 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 \[1\]. 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 Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
24mo left

Started Jun 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 17, 2026

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2028

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2028

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

April 19, 2026

Last Update Submit

April 26, 2026

Conditions

Keywords

MPFL reconstruction

Outcome Measures

Primary Outcomes (3)

  • Kujala Score for knee function

    12 months post operative

  • Lysholm score for knee function

    12 month

  • Redislocation rate

    12 months

Secondary Outcomes (2)

  • Range of motion

    12 month

  • Complications

    12months

Study Arms (2)

MPFL Reconstruction For Recurrent patellar displacement in children

EXPERIMENTAL

MPFL reconstruction

Procedure: MPFL Reconstruction

Combined MPFL and MPTL for Recurrent patellar displacement in children

EXPERIMENTAL

MPFL +MPTL Reconstruction

Procedure: MPFL + MPTL Reconstruction

Interventions

Medial patellofemoral ligament reconstruction

MPFL Reconstruction For Recurrent patellar displacement in children

Combined medial patellofemoral and mediopatellotibial ligaments reconstruction

Combined MPFL and MPTL for Recurrent patellar displacement in children

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 37469733BACKGROUND
  • 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.

    PMID: 28620562BACKGROUND
  • 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.

    PMID: 34805364BACKGROUND
  • 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.

    PMID: 33121878BACKGROUND
  • 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.

    PMID: 35246187BACKGROUND
  • 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.

    PMID: 28641151BACKGROUND
  • 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.

    PMID: 34837157BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 19, 2026

First Posted

May 4, 2026

Study Start (Estimated)

June 17, 2026

Primary Completion (Estimated)

March 17, 2028

Study Completion (Estimated)

June 17, 2028

Last Updated

May 4, 2026

Record last verified: 2026-04