NCT05629754

Brief Summary

Patellofemoral pain is a common complaint especially in young adults. It can be caused by patellar maltracking. Part of this is a patella alta. When patellar maltracking is the cause of the problem and conservative therapy fails, surgery, a tibial tuberosity transposition, may be considered. Most research has been done in patients with recurrent patella luxation. However, in patients without luxation, research is scarce. It is known that patients with patella alta have an increased risk of developing patellofemoral chondropathy due to increased pressure. With this study, we aim to investigate whether and how a tibial tuberosity transposition in patients with patella alta and no instability affects the degree of patellofemoral chondropathy and patient satisfaction after 10 years. This will allow us to educate patients regarding long-term outcomes better.

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
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 29, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

November 18, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

November 9, 2022

Last Update Submit

November 21, 2023

Conditions

Keywords

Tibial tubercle transferLong-term follow-up

Outcome Measures

Primary Outcomes (1)

  • Modified Outerbridge Classification

    Degree of retropatellar cartilage damage

    10-year follow-up assessment

Secondary Outcomes (4)

  • Patellar height

    10-year follow-up assessment

  • Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire

    10-year follow-up assessment

  • Kujala Anterior Knee Pain Score (AKPS) questionnaire

    One measurement

  • Visual Analogue Scale (VAS) for pain

    10-year follow-up assessment

Interventions

MRI and radiological assessment of the involved knee

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients whom around 10 years ago presented with anterior knee pain and patella maltracking without instability, where conservative therapy failed and a TTT was performed, and who participated in the original cohort.

You may qualify if:

  • Age between 18 and 80 years
  • Participated in an earlier cohort study
  • Underwent a tibial tubercle transposition between 2012 and 2015
  • Preoperative MRI available

You may not qualify if:

  • No preoperative MRI is available
  • Patellar-related surgery after the initial surgery
  • Female patients that are (expecting to be) pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Noordwest Ziekenhuisgroep

Alkmaar, North Holland, 1815 JD, Netherlands

Location

Related Publications (1)

  • Bayoumi T, van Duijvenbode DC, Benner JL, Boerma-Argelo KDS, Stavenuiter MHJ, van der List JP. Clinical Improvement Is Achieved Following Tibial Tubercle Distomedialization for Patellar Maltracking and Patella Alta Without Instability. Arthrosc Sports Med Rehabil. 2021 Jun 15;3(3):e845-e853. doi: 10.1016/j.asmr.2021.01.027. eCollection 2021 Jun.

    PMID: 34195653BACKGROUND

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • JL Benner, PhD

    Noordwest Ziekenhuisgroep

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 9, 2022

First Posted

November 29, 2022

Study Start

November 18, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

November 24, 2023

Record last verified: 2023-11

Locations