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

NCT05432609 | Active Not Recruiting DMC FDA Device

• 1 other identifier: H-20068116
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Musculoskeletal Diseases

Outcome Measures

Primary Outcomes (1)

• Measurement of patellofemoral indices

  Intra and interrater reliability and day to day repeatability

  1 year

Study Arms (2)

Healthy

Weight bearing CT in fully extended and flexed (20 degrees) position, loaded and unloaded, respectively.

Diagnostic Test: Weight bearing CT

Trochlear dysplasia

Weight bearing CT in fully extended and flexed (20 degrees) position, loaded and unloaded, respectively.

Diagnostic Test: Weight bearing CT

Interventions

Weight bearing CT DIAGNOSTIC_TEST

Weight bearing CT in loaded and unloaded positions

Healthy; Trochlear dysplasia

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy participants recruited amongst employees in the ER, Bispebjerg-Frederiksberg Hospital Trochlear dysplasia patients selected from the sports surgery unit, Bispebjerg-Frederiksberg Hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Dept. of Radiology, Bispebjerg-Frederiksberg Hospital

Copenhagen, 2000, Denmark

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

• Signe Brinch, MD

  University Hospital Bispebjerg and Frederiksberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD, PhD student

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 27, 2022
• Study Start: September 1, 2021
• Primary Completion: October 31, 2024
• Study Completion: September 15, 2025
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

DK (1)