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Recruiting NCT06086080

Non-operative Treatment in First-time Patellar Dislocation

No phase Interventional Patellar Dislocation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard care, Taping, Sham taping.
Who it may be relevant to
Registry conditions: Patellar Dislocation. Basic parameters: 10 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Colombia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • 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
  • Device Sham taping
    Taping with no treatment disposition

Primary outcome measures

  • Recurrent patellar dislocation (percentage of patients) [Time frame: 2 years]
Secondary outcome measures (2)
  • Banff Patellofemoral Instability Instrument (BPII) [Time frame: 2 years]
  • Nich patellar instability (NPI) score [Time frame: 2 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Double blind
Primary purpose
Treatment

Study locations

Colombia · 1 center
  • Fundación Valle del Lili — Cali

Identifiers

NCT: NCT06086080 · 1906

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗