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Non-operative Treatment in First-time Patellar Dislocation

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06086080
Enrollment
50
Registered
2023-10-17
Start date
2023-10-02
Completion date
2027-12-01
Last updated
2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patellar Dislocation

Keywords

Patellar dislocation, Brace, Knee taping

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: 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

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

Sponsors

International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine
CollaboratorUNKNOWN
Fundacion Clinica Valle del Lili
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

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

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
10 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Recurrent patellar dislocation (percentage of patients)2 yearsPercentage of patients with additional patellar dislocation after the first episode

Secondary

MeasureTime frameDescription
Banff Patellofemoral Instability Instrument (BPII)2 yearsPatellofemoral 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) score2 yearsPatellofemoral 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%.

Other

MeasureTime frameDescription
Patellar tilt angle of patients after the first episode1 monthPatellar tilt in magnetic resonance imaging (angle in degrees)
Percentage of participants that return to sport activity2 yearsPercentage of the patients that were able to return to do their usual sport after the initial injury (patellar dislocation)
Patellar apprehension test2 yearsPatellar 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.
Percentage of participants with patellar J sign2 yearsJ 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.

Countries

Colombia

Contacts

Primary ContactJuan P Martinez, MD
juan.martinez.ca@fvl.org.co+576023319090
Backup ContactAlejandro Gallego, MD
alejandro.gallego.al@fvl.org.co+576023319090

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026