NCT06009822

Brief Summary

Our aim in this study is to examine the functional and clinical results of patients who have undergone MPFL reconstruction at least 2 years after the operation. The presence of kinesiophobia of the patients will be evaluated and its relationship with functional outcomes will be examined.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

August 8, 2023

Last Update Submit

August 22, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Kinesiophobia

    Kinesiophobia refers to an excessive, irrational fear of movement or physical activity. The Tampa Scale for Kinesiophobia was used for assessment. The Tampa Scale for Kinesiophobia is scored between 17-68. A high score indicates high kinesiophobia.

    up to 3 months

Secondary Outcomes (5)

  • Knee Score

    up to 3 months

  • Patellofemoral Knee Score

    up to 3 months

  • Single-leg hop test

    up to 3 months

  • Dynamic balance

    up to 3 months

  • Static balance

    up to 3 months

Study Arms (1)

Patients with Medial Patellofemoral Ligament reconstruction

Must have undergone unilateral medial patellofemoral ligament (MPFL) reconstruction. At least 2 years post MPFL reconstruction surgery. Absence of patellar instability subsequent to the surgical procedure. Exclusion of patients with any orthopedic or neurological issues that might impact functionality, except for those who have undergone unilateral MPFL reconstruction.

Other: Postoperative outcome measurements

Interventions

Kinesiophobia; It will be assessed on the Tampa Kinesiophobia Scale. Function; Lysholm knee score, kujala knee score, single-leg hop test, Y balance test and single leg sway index will be evaluated. Biodex Bio-balance system device will be used for single leg sway index.

Patients with Medial Patellofemoral Ligament reconstruction

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent unilateral MPFL reconstruction in the Department of Orthopedics and Traumatology, Gazi University Hospital between 2004 and 2019

You may qualify if:

  • Undergone unilateral medial patellofemoral ligament (MPFL) reconstruction
  • At least 2 years after the operation

You may not qualify if:

  • Patellar instability
  • Knee ligament injury
  • Meniscus injury
  • Knee osteoarthritis
  • Ankle ligament injury
  • Ankle osteoarthritis
  • Any neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Kinesiophobia

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Zeynep Hazar

    Gazi University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research asistant (PT)

Study Record Dates

First Submitted

August 8, 2023

First Posted

August 24, 2023

Study Start

August 1, 2023

Primary Completion

September 30, 2023

Study Completion

October 1, 2023

Last Updated

August 24, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations