Non-operative Treatment in First-time Patellar Dislocation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-40
SponsorFundacion Clinica Valle del Lili

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Patients with open patellar dislocation.

Patients with previous knee surgery in the same knee.

Trial design

Design model

Factorial

Treatments tested in this trial

  • Standard care

    Other intervention

    Bracing and physical therapy

  • Taping

    Other intervention

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

  • Sham taping

    Device

    Taping with no treatment disposition

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Control groupOther 2 interventions
Group B: Intervention groupExperimental treatment 2 interventions

Trial outcomes

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

Sponsors and contacts

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Fundacion Clinica Valle del Lili

Lead sponsor

International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine

Collaborator