Patellar (or Kneecap) Instability and Mal-alignment
Conditions
Brief summary
The primary hypothesis is that measures of patellofemoral alignment obtained from the investigational cone beam CT scanner will be reduced, but still correlated to those obtained from the conventional CT scan.
Interventions
None listed
Sponsors
Carestream Health, Inc.
State University of New York at Buffalo
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who have been diagnosed with acute or chronic patellar malalignment. * At least 16 years old * Be willing and able to provide informed consent
Exclusion criteria
* Open growth plates * Previous knee surgery on the affected knee * Pregnancy (females) * Fracture of the patellofemoral joint * Knee ligament injury (other than medial patellofemoral ligament) * Have greater than Grade II degenerative changes of the patellofemoral joint * Inability to bear weight on the extremity during the CT scan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Congruence Angle CBCT | Baseline |
Secondary
| Measure | Time frame |
|---|---|
| Tilt Angle | Baseline |
| Tibial Tuberosity Trochlear Groove | Baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cases Case-only study, patients with patellar instability or mal-alignment | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Cases |
|---|---|
| Age, Categorical <=18 years | 4 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Age, Continuous | 27.5 years STANDARD_DEVIATION 10.5 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Congruence Angle CBCT
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional CT | Congruence Angle CBCT | 26.7 degrees | Standard Deviation 18.1 |
| CBCT | Congruence Angle CBCT | 3 degrees | Standard Deviation 30.1 |
Secondary
Tibial Tuberosity Trochlear Groove
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional CT | Tibial Tuberosity Trochlear Groove | 12.3 mm | Standard Deviation 6.3 |
Secondary
Tilt Angle
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional CT | Tilt Angle | 18.2 degrees | Standard Deviation 11.6 |