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Non-operative Treatment in First-time Patellar Dislocation

Primary Purpose

Patellar Dislocation

Status
Recruiting
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Standard care
Taping
Sham taping
Sponsored by
Fundacion Clinica Valle del Lili
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellar Dislocation focused on measuring Patellar dislocation, Brace, Knee taping

Eligibility Criteria

10 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fundación Valle del LiliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control group

Intervention group

Arm Description

Standard care: knee brace for 2 weeks, physical therapy, sham taping (2-weeks)

Knee taping for 4-weeks, knee brace for 1 week, physical therapy

Outcomes

Primary Outcome Measures

Recurrent patellar dislocation (percentage of patients)
Percentage of patients with additional patellar dislocation after the first episode

Secondary Outcome Measures

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.
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%.

Full Information

First Posted
October 3, 2023
Last Updated
October 19, 2023
Sponsor
Fundacion Clinica Valle del Lili
Collaborators
International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT06086080
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2023 (Actual)
Primary Completion Date
October 1, 2027 (Anticipated)
Study Completion Date
December 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion Clinica Valle del Lili
Collaborators
International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: Standard treatment (2-weeks with a knee brace) and physical therapy 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellar Dislocation
Keywords
Patellar dislocation, Brace, Knee taping

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
The investigator and outcomes assessor will not have access to the type of treatment a patient received.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Other
Arm Description
Standard care: knee brace for 2 weeks, physical therapy, sham taping (2-weeks)
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Knee taping for 4-weeks, knee brace for 1 week, physical therapy
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Bracing and physical therapy
Intervention Type
Other
Intervention Name(s)
Taping
Intervention Description
The patient is treated with tape in special configuration (McConell modified) for the patella + standard care
Intervention Type
Device
Intervention Name(s)
Sham taping
Intervention Description
Taping with no treatment disposition
Primary Outcome Measure Information:
Title
Recurrent patellar dislocation (percentage of patients)
Description
Percentage of patients with additional patellar dislocation after the first episode
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Banff Patellofemoral Instability Instrument (BPII)
Description
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.
Time Frame
2 years
Title
Nich patellar instability (NPI) score
Description
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%.
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Patellar tilt angle of patients after the first episode
Description
Patellar tilt in magnetic resonance imaging (angle in degrees)
Time Frame
1 month
Title
Patellar apprehension test
Description
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.
Time Frame
2 years
Title
Percentage of participants with patellar J sign
Description
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.
Time Frame
2 years
Title
Percentage of participants that return to sport activity
Description
Percentage of the patients that were able to return to do their usual sport after the initial injury (patellar dislocation)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan P Martinez, MD
Phone
+576023319090
Email
juan.martinez.ca@fvl.org.co
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandro Gallego, MD
Phone
+576023319090
Email
alejandro.gallego.al@fvl.org.co
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan P Martinez, MD
Organizational Affiliation
Fundacion Clinica Valle del Lili
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundación Valle del Lili
City
Cali
State/Province
Valle
ZIP/Postal Code
760032
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandro Gallego, MD
Phone
+576023319090
Email
alejandro.gallego.al@fvl.org.co

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Non-operative Treatment in First-time Patellar Dislocation

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