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NCT Number: NCT05432609

Standardization and Reproducibility Regarding Scanning Procedures and Measurements of Weight-bearing Cone Beam CT in the Lower Extremity

Cone Beam CT (CBCT) of the knee is gaining interest, especially regarding patients suffering from patellofemoral instability. With this study investigators wish to investigate the day-to-day, test-retest reliability of weight bearing (WB) and non-weight bearing (NWB) CBCT of the knee in healthy participants and patients suffering from trochlear dysplasia. The participants and patients will be scanned in the following positions: 0° WB, 0° NWB, 20° WB, 20° NWB on two separate days. The trochlear dysplasia patients will furthermore be scanned 6 months postoperatively.

The aim is to develop af protocol on how to both position patients during weight bearing scannings as well as a protocol on how to prepare the cross sectional images before measurements.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. of Radiology, Bispebjerg-Frederiksberg Hospital

Copenhagen, 2000, Denmark

About this study

Investigators expect that scans performed with CBCT will show a clear change in the TT-TG distance when comparing scans performed in two different degrees of flexion of the knee. Investigators expect a discrete change in the TT-TG distance between non-weight bearing and weight-bearing state of the same degree of flexion. Investigators expect that other radiological targets for assessing patellofemoral instability, e.g. in trochlear dysplasia patients will change between the different scan situations. In addition, investigators expect that the TT-TG distance measurement method has a high reproducibility of intra- and in-terobserver variation as well as over time with repeated scans. The reproducibility is expected to be at least as good or above existing 2D measurement methods on conventional scans. In patients with trochlear dysplasia, a greater TT-TG distance is expected than in healthy controls. In addition, differences in TT-TG distance between flexion/extension as well as between non-weight bearing and weight bearing condition are expected to be greater than in healthy controls. In addi-tion, investigators expect to be able to detect a correlation between controlled changes in the position of the foot which will lead to passive changes in the TT-TG distance.

The purpose of the study is:

  • To investigate changes in TT-TG distance in CBCT scans of the knee joint, in healthy con-trols as well as in trochlear dysplasia patients, in two predefined degrees of flexion (0 ° i.e. fully stretched position; 20 ° flexion), in respectively weight-bearing loaded and unloaded position
  • To investigate the day-to-day reliability of the measured TT-TG distance, knee flexion angle and other radiological measurements regarding patellofemoral instability, at two separate CBCT scan sessions in patients with trochlear dysplasia compared with healthy controls
  • To investigate changes in the TT-TG distance in trochlear dysplasia patients before and after surgery in terms of evaluation of the patellofemoral instability

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Substudy 1:Healthy

  • Male or female aged 18-39 years
  • Must be able to stand on one leg for 30 seconds

Substudy 2

  • Diagnosed with trochlear dysplasia, in addition healthy
  • Male or female aged 18-39 years
  • Patients scheduled to either a trochlear plastic surgery + MPFL reconstruction or Elmslie- Trillat + MPFL reconstruction + trochlear plastic surgery
  • Must be able to stand on one leg for 30 seconds

Exclusion criteria

Substudy 1

  • Current knee injury and / or knee pain.
  • Known rheumatoid and / or connective tissue disease.
  • Previous treatment requiring knee injury and / or knee surgery.
  • Pregnancy

Substudy 2

  • Known rheumatoid and / or connective tissue disease
  • Previous treatment requiring knee injury and / or knee surgery.
  • Patients who need distalization
  • Pregnancy

Treatment and study plan

Weight bearing CT

Diagnostic Test

Weight bearing CT in loaded and unloaded positions

Primary outcomes

  1. Measurement of patellofemoral indices

    Time frame: 1 year

    Intra and interrater reliability and day to day repeatability

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jun 27, 2022
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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