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RecruitingNCT06086080Updated Apr 3, 2025

Non-operative Treatment in First-time Patellar Dislocation

An interventional study of Standard care and Taping in Patellar Dislocation, sponsored by Fundacion Clinica Valle del Lili. Recruiting at 1 site in Colombia. Open to participants aged 10 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-04-03.

Sponsored by Fundacion Clinica Valle del Lili · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
10 Years to 40 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Patellar Dislocation

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Keywords

  • Patellar dislocation
  • Brace
  • Knee taping
03

In context

Patellar Dislocation

41 studies on the registry are indexed under Patellar Dislocation; 9 are open to participants now.

This study's planned enrollment of 50 is close to the median of 50 across 22 interventional studies indexed under Patellar Dislocation.

Browse Patellar Dislocation studies →

Lead sponsor

Fundacion Clinica Valle del Lili is the lead sponsor of 25 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

* Patients with acute bilateral patellar dislocation.

  • Patients with open patellar dislocation.
  • Patients with previous knee surgery in the same knee.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Other
    Control group

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

    Other: Standard care · Device: Sham taping

  • Experimental
    Intervention group

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

    Other: Standard care · Other: Taping

Interventions

  • OtherStandard care

    Bracing and physical therapy

  • OtherTaping

    The patient is treated with tape in special configuration (McConell modified) for the patella + standard care

  • DeviceSham taping

    Taping with no treatment disposition

06

What researchers measure

Primary outcomes

  1. Recurrent patellar dislocation (percentage of patients)

    Percentage of patients with additional patellar dislocation after the first episode

    Time frame: 2 years

Secondary outcomes

  1. 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.

    Time frame: 2 years

  2. 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%.

    Time frame: 2 years

Other outcomes

  1. Patellar tilt angle of patients after the first episode

    Patellar tilt in magnetic resonance imaging (angle in degrees)

    Time frame: 1 month

  2. 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.

    Time frame: 2 years

  3. 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.

    Time frame: 2 years

  4. 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)

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — All individual participant data that underlie results in a publication.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: For 5 years after publishing the paper.

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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2023 (actual). Primary completion is estimated for Oct 2027, 47 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 3, 2023
First posted
Oct 17, 2023
StartActual
Oct 2, 2023
Primary completionEst.
Oct 1, 2027
CompletionEst.
Dec 1, 2027
Last update
Apr 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06086080
Lead sponsor
Fundacion Clinica Valle del Lili
Collaborators
International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine
Responsible party
Sponsor
First posted
Oct 17, 2023
Start date
Oct 2, 2023
Primary completion
Oct 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Apr 3, 2025

Study contacts

Juan P Martinez, MD
Contact
juan.martinez.ca@fvl.org.co
+576023319090
Alejandro Gallego, MD
Contact
alejandro.gallego.al@fvl.org.co
+576023319090
Juan P Martinez, MD
principal investigator · Fundacion Clinica Valle del Lili

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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