Non-operative Treatment in First-time Patellar Dislocation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Patellar Dislocation
• Intervention / Treatment: Other: Standard care; Device: Sham taping; Other: Taping

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

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juan P Martinez, MD; Phone Number: +576023319090; Email: juan.martinez.ca@fvl.org.co
• Study Contact Backup: Name: Alejandro Gallego, MD; Phone Number: +576023319090; Email: alejandro.gallego.al@fvl.org.co

Study Locations

• Colombia
  • Valle
    • Cali, Valle, Colombia, 760032
      • Recruiting
      • Fundación Valle del Lili
      • Contact: Alejandro Gallego, MD; Phone Number: +576023319090; Email: alejandro.gallego.al@fvl.org.co

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group; Standard care: knee brace for 2 weeks, physical therapy, sham taping (2-weeks)	Other: Standard care; Bracing and physical therapy; Device: Sham taping; Taping with no treatment disposition
Experimental: Intervention group; Knee taping for 4-weeks, knee brace for 1 week, physical therapy	Other: Standard care; Bracing and physical therapy; Other: Taping; The patient is treated with tape in special configuration (McConell modified) for the patella + standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrent patellar dislocation (percentage of patients)	Percentage of patients with additional patellar dislocation after the first episode	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patellar tilt angle of patients after the first episode	Patellar tilt in magnetic resonance imaging (angle in degrees)	1 month
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
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
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

Collaborators and Investigators

• Sponsor: Fundacion Clinica Valle del Lili
• Collaborators: International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine
• Investigators: Principal Investigator: Juan P Martinez, MD, Fundacion Clinica Valle del Lili

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Brace; Patellar dislocation; Knee taping
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Wounds and Injuries; Joint Diseases; Leg Injuries; Knee Injuries; Joint Dislocations; Patellar Dislocation
• Other Study ID Numbers: 1906 (Assiut Univeristy Faculty of Medicine Ethical Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data that underlie results in a publication.
• IPD Sharing Time Frame: For 5 years after publishing the paper.
• IPD Sharing Access Criteria: Data will be shared if it is found to be relevant for understanding better the study or the analysis. This includes the journal where the paper is submitted and investigators with interest in the study.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No