Clinical trial NCT06517056: Emovi 3D Knee Assessment Device Intervention for Operational Readiness
Official title: Objective Dynamic and 3D Knee Assessment Medical Device to Improve Recovery and Accelerate Return to Readiness in Service Members with Knee Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patellofemoral Pain
Patellofemoral Pain Syndrome
Keywords: Patellofemoral Pain
Patellofemoral Pain Syndrome
Lead sponsor: Womack Army Medical Center
Sponsor class: FED
Collaborators: name: The Geneva Foundation
First posted: 2024-07-24
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study design is with 1:1 treatment arms: 1) KneeKG informed cared or 2) usual care without any information from the KneeKG
Primary purpose: DIAGNOSTIC

Brief summary: This is a randomized clinical trial investigating the use of the Emovi Knee Kinesiography information in the treatment of anterior knee pain in physical therapy.

Detailed description: The purpose of this study is to assess the effectiveness of using a 3D medical assessment device versus usual care to help guide clinical decisions about the management of PFP. The objective is to determine if gathering objective biomechanical data from a three-dimensional (3D) motion capture device leads to more precise and optimal care, ultimately improving physical function and other outcomes compared to participants who receive routine care that is not guided by information from this device.

Participants will be recruited from primary care and physical therapy clinics at participating sites. Authorized study personnel will search electronic medical records (Genesis) to identify potential study participants diagnosed with knee pain.

After consent and enrollment, participants will complete baseline measures and then receive a Knee Kinesiography exam. The participant will be entered into the KneeKG system using a unique participant identifier. After the knee kinesiography exam with the KneeKG, participants will be randomized 1:1 into one of two different treatment arms: 1) KneeKG informed care or 2) usual care without any information from the KneeKG.

Knee mechanics during gait is assessed with a Knee Kinesiography exam. The participant will walk for 5 minutes on a commercial treadmill at their comfortable speed. Three-dimensional (3D) knee kinematics are captured on each leg using the KneeKG system (Emovi, Canada). With this validated FDA cleared medical device, there is an accurate quantification of specific knee biomechanical markers during gait in a clinical setting. There will be two 45-second trials to electronically capture the data which is immediately accessible through automatic reports. Biomechanical markers captured include but are not limited to varus/valgus alignment at stance, varus/valgus alignment at heel strike, knee flexion angle at heel strike, total knee excursion in sagittal plane, tibial rotation at heel strike and throughout gait cycle. The entire procedure will take approximately 15-20 minutes. This procedure will occur at baseline and also again at 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Age 18-50
* Active Duty Service Member stationed at Fort Liberty and Schofield Barracks
* Diagnosis of patellofemoral pain (ICD-10 codes: M25.2 (pain in unspecified knee), M25.561 (pain in right knee), and M25.562 (pain in left knee)

Exclusion Criteria:

* Pregnancy
* Known to be leaving that duty station within next 3 months
* Concurrent lower limb injuries (examples include but are not limited to ankle sprain or HS strain)
* Previous knee surgery
* History of traumatic knee injury, such as a ligament tear or meniscal tear
* Presence of rheumatoid or neurological disease

Primary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function
timeFrame: 12 weeks
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
timeFrame: 12 weeks
measure: Anterior Knee Pain Scale (AKPS)
timeFrame: 12 weeks
measure: Self-Reported Readiness to Return to Duty
timeFrame: 12 weeks
measure: Total Lost Duty Days
timeFrame: 12 weeks
measure: Provider Satisfaction
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Tripler Army Medical Center
state: Hawaii
city: Fort Liberty
country: United States
facility: Womack Army Medical Center
state: North Carolina
Study officials:
affiliation: Womack Army Medical Center
name: Don L Goss, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: