10-year Follow-up After Tibial Tubercle Transposition

Anterior Knee Pain Syndrome Clinical Trial

— TTTfollow-up  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05629754
• Other study ID #: NL82613.029.22
• Status: Enrolling by invitation
• Start date: November 18, 2023
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Centre for Orthopaedic Research Alkmaar
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 32
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Knee Pain Syndrome
• Patellofemoral Pain Syndrome

Intervention

Diagnostic Test:
• MRI, radiological assessment
MRI and radiological assessment of the involved knee

Locations

Country	Name	City	State
Netherlands	Noordwest Ziekenhuisgroep	Alkmaar	Noord Holland

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Orthopaedic Research Alkmaar	Noordwest Ziekenhuisgroep

Country where clinical trial is conducted

Netherlands, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Outerbridge Classification	Degree of retropatellar cartilage damage	10-year follow-up assessment
Secondary	Patellar height	Patellar height measured by radiological assessment lateral view	10-year follow-up assessment
Secondary	Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire	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
Secondary	Kujala Anterior Knee Pain Score (AKPS) questionnaire	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
Secondary	Visual Analogue Scale (VAS) for pain	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