Non-operative Treatment in First-time Patellar Dislocation

Patellar Dislocation Clinical Trial

Official title:

Non-operative Treatment in First-time Patellar Dislocation: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06086080
• Other study ID #: 1906
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: December 1, 2027

Study information

• Verified date: October 2023
• Source: Fundacion Clinica Valle del Lili
• Contact: Juan P Martinez, MD
• Phone: +576023319090
• Email: juan.martinez.ca[@]fvl.org.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2027
• Est. primary completion date: October 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Patellar Dislocation

Intervention

Other:
• Standard care
Bracing and physical therapy
• Taping
The patient is treated with tape in special configuration (McConell modified) for the patella + standard care

Device:
• Sham taping
Taping with no treatment disposition

Locations

Country	Name	City	State
Colombia	Fundación Valle del Lili	Cali	Valle

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion Clinica Valle del Lili	International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patellar tilt angle of patients after the first episode	Patellar tilt in magnetic resonance imaging (angle in degrees)	1 month
Other	Patellar apprehension test	Patellar apprehension test during physical examination. The quadriceps should be relaxed to allow passive movements of the patella. The clinician will perform this technique by using their thumb of both hands, and pressing on the medial side of the patient's patella. The test is positive if it produces pain and apprehension.	2 years
Other	Percentage of participants with patellar J sign	J sign during physical examination. The J-sign refers to the inverted 'J' track the patella takes from extension to early flexion. The J-sign is a clinical finding indicative of patellar maltracking.	2 years
Other	Percentage of participants that return to sport activity	Percentage of the patients that were able to return to do their usual sport after the initial injury (patellar dislocation)	2 years
Primary	Recurrent patellar dislocation (percentage of patients)	Percentage of patients with additional patellar dislocation after the first episode	2 years
Secondary	Banff Patellofemoral Instability Instrument (BPII)	Patellofemoral instability specific score to assess function (disease-specific). The punctuation range is between 0-100 points. The best health scenario is 100% and the worst is 0.	2 years
Secondary	Nich patellar instability (NPI) score	Patellofemoral instability specific score to assess function (disease-specific). The punctuation range is between 0-100%. The worst health deficit is 100% and the best is 0%.	2 years