Clinical trial NCT06086080: Non-operative Treatment in First-time Patellar Dislocation
Official title: Non-operative Treatment in First-time Patellar Dislocation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patellar Dislocation
Keywords: Patellar dislocation
Brace
Knee taping
Lead sponsor: Fundacion Clinica Valle del Lili
Sponsor class: OTHER
Collaborators: name: International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine
First posted: 2023-10-17
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Patients are randomized either to standard care or in the intervention group. Standard care patients are treated with knee brace (2 weeks) and physical therapy. In the intervention group: they receive knee taping with knee brace during 1-week.
Primary purpose: TREATMENT

Brief summary: Study to evaluate the conservative treatment of patients after their first episode of primary lateral patellar dislocation. Randomized controlled trial with 2 groups: standard treatment (2-weeks with brace) followed by physical therapy, compared with knee taping and physical therapy. 1-year follow-up. Measurements include physical exam, radiographs and MRI. Outcomes: recurrence, lateral patellar tilt, functional scores, apprehension, pain.

Hypothesis: less recurrence in the knee taping group, as well as better functional scores.

Detailed description: Patients between 10-40 years old with first patellar dislocation are invited to participate in this conservative treatment study.

Patients are excluded if they have bilateral acute patellar dislocation, previous surgeries in the affected knee, osteochondral fracture, open patellar dislocation.

This is a randomized controlled trial with four groups of treatment:

1. Standard treatment (2-weeks with a knee brace) and physical therapy
2. Knee taping and physical therapy (1-week with knee brace)

Sample size: 50 patients / knees Outcomes of interest: recurrence in patellar dislocation, functional scores (Banff, Norwich), return to sport, patellar tilt

Eligibility criteria: Inclusion Criteria:

- Patients with first episode of acute lateral patellar dislocation during the last 7 days.

Exclusion Criteria:

\* Patients with acute bilateral patellar dislocation.

* Patients with open patellar dislocation.
* Patients with previous knee surgery in the same knee.

Primary outcomes:
measure: Recurrent patellar dislocation (percentage of patients)
timeFrame: 2 years
Secondary outcomes:
measure: Banff Patellofemoral Instability Instrument (BPII)
timeFrame: 2 years
measure: Nich patellar instability (NPI) score
timeFrame: 2 years
Other outcomes:
measure: Patellar tilt angle of patients after the first episode
timeFrame: 1 month
measure: Patellar apprehension test
timeFrame: 2 years
measure: Percentage of participants with patellar J sign
timeFrame: 2 years
measure: Percentage of participants that return to sport activity
timeFrame: 2 years
Locations:
city: Cali
country: Colombia
facility: Fundación Valle del Lili
state: Valle
Study officials:
affiliation: Fundacion Clinica Valle del Lili
name: Juan P Martinez, MD
role: PRINCIPAL_INVESTIGATOR
References: