TTT Follow-up Study

August 29, 2023 updated by: Joyce L Benner, PhD, Centre for Orthopaedic Research Alkmaar

Long-term Outcomes and Development of Retropatellar Chondropathy After Tibial Tubercle Distomedialisation for Patellar Maltracking and Patella Alta Without Instability: 10 Year Follow-up of a Prospective Cohort

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Anterior knee pain is a common complaint, especially in younger and active adults. An obvious source for anterior knee pain is patellar maltracking, which is often associated with patella alta (a high-riding patella). Due to maltracking, the cartilage of the patella can face a greater amount of pressure, which can cause cartilage damage. When conservative treatment fails, a surgical intervention can be considered. One of the surgical options is performing a tibial tubercle transfer (TTT), where the patella is being distalized and medialized. As a result, the improvement in patellar tracking will reduce the pressure on the retropatellar cartilage. The TTT has been proven effective in patients with patellar instability but less is known about patients without instability. Specifically, whether these patients face a higher risk of developing retropatellar cartilage damage ('retropatellar chondropathy') due to this intervention is currently unknown.

The primary aim of this study is to determine the incidence and the degree of retropatellar chondropathy 10 years after a TTT in patients with anterior knee pain without patellar instability. The secondary aim is to evaluate the long-term patient reported outcomes (PROMs) 10 years after a TTT in patients with anterior knee pain without patellar instability.

Study Type

Observational

Enrollment (Estimated)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • Noord Holland
      • Alkmaar, Noord Holland, Netherlands, 1815 JD
        • Recruiting
        • Noordwest Ziekenhuisgroep
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Outerbridge Classification
Time Frame: 10-year follow-up assessment
Degree of retropatellar cartilage damage
10-year follow-up assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patellar height
Time Frame: 10-year follow-up assessment
Patellar height measured by radiological assessment lateral view
10-year follow-up assessment
Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Time Frame: 10-year follow-up assessment
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
10-year follow-up assessment
Kujala Anterior Knee Pain Score (AKPS) questionnaire
Time Frame: One measurement
The Kujala AKPS is a 13-item screening instrument designed to assess patellofemoral pain in adolescents and young adults, with a variable ordinal response format (e.g., no pain (5) to constant pain (0)). Total scores range from 0 to 100, with a higher score indicating less symptoms.
One measurement
Visual Analogue Scale (VAS) for pain
Time Frame: 10-year follow-up assessment
The pain VAS is a unidimensional measure of pain intensity, scored from 0 (no pain) to 100 (highest possible pain intensity).
10-year follow-up assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Orthopaedic Research Alkmaar

Collaborators

Noordwest Ziekenhuisgroep

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 9, 2022

First Submitted That Met QC Criteria

November 17, 2022

First Posted (Actual)

November 29, 2022

Study Record Updates

Last Update Posted (Estimated)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL82613.029.22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anterior Knee Pain Syndrome

Clinical Trials on MRI, radiological assessment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe