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TTT Follow-up Study

Sponsor
Centre for Orthopaedic Research Alkmaar (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05629754
Collaborator
Noordwest Ziekenhuisgroep (Other)
32
Enrollment
9
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: MRI, radiological assessment

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 Design

Study Type:
Observational
Anticipated Enrollment :
32 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
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
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Modified Outerbridge Classification [10-year follow-up assessment]

    Degree of retropatellar cartilage damage

Secondary Outcome Measures

  1. Patellar height [10-year follow-up assessment]

    Patellar height measured by radiological assessment lateral view

  2. Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire [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.

  3. Kujala Anterior Knee Pain Score (AKPS) questionnaire [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.

  4. Visual Analogue Scale (VAS) for pain [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Centre for Orthopaedic Research Alkmaar
  • Noordwest Ziekenhuisgroep

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr. J.L. Benner, Principal Investigator, Centre for Orthopaedic Research Alkmaar
ClinicalTrials.gov Identifier:
NCT05629754
Other Study ID Numbers:
  • NL82613.029.22
First Posted:
Nov 29, 2022
Last Update Posted:
Nov 29, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. J.L. Benner, Principal Investigator, Centre for Orthopaedic Research Alkmaar
Tibial tubercle transfer
Long-term follow-up
Additional relevant MeSH terms:
Patellofemoral Pain Syndrome

Study Results

No Results Posted as of Nov 29, 2022