Non-operative Treatment in First-time Patellar Dislocation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-02

Study Completion Date

2027-12-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Patellar Dislocation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

The investigator and outcomes assessor will not have access to the type of treatment a patient received.

Study Groups

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Control group

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

Group Type OTHER

Standard care

Intervention Type OTHER

Bracing and physical therapy

Sham taping

Intervention Type DEVICE

Taping with no treatment disposition

Intervention group

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

Group Type EXPERIMENTAL

Standard care

Intervention Type OTHER

Bracing and physical therapy

Taping

Intervention Type OTHER

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

Interventions

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Standard care

Bracing and physical therapy

Intervention Type OTHER

Taping

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

Intervention Type OTHER

Sham taping

Taping with no treatment disposition

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No