Non-operative Treatment in First-time Patellar Dislocation

NCT06086080 | Recruiting DMC

• 1 other identifier: 1906
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Patellar Dislocation

Keywords

Patellar dislocation; Brace; Knee taping

Outcome Measures

Primary Outcomes (1)

• Recurrent patellar dislocation (percentage of patients)

  Percentage of patients with additional patellar dislocation after the first episode

  2 years

Secondary Outcomes (2)

• Banff Patellofemoral Instability Instrument (BPII)

  2 years

• Nich patellar instability (NPI) score

  2 years

Other Outcomes (4)

• Patellar tilt angle of patients after the first episode

  1 month

• Patellar apprehension test

  2 years

• Percentage of participants with patellar J sign

  2 years

Study Arms (2)

Control group

OTHER

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

Other: Standard care; Device: Sham taping

Intervention group

EXPERIMENTAL

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

Other: Standard care; Other: Taping

Interventions

Standard care OTHER

Bracing and physical therapy

Control group; Intervention group

Taping OTHER

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

Intervention group

Sham taping DEVICE

Taping with no treatment disposition

Control group

Eligibility Criteria

• Age: 10 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \* Patients with acute bilateral patellar dislocation.
• Patients with open patellar dislocation.
• Patients with previous knee surgery in the same knee.

Sponsors & Collaborators

• Fundacion Clinica Valle del Lili: lead
• International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine: collaborator

Study Sites (1)

Fundación Valle del Lili

Cali, Valle del Cauca Department, 760032, Colombia

RECRUITING

MeSH Terms

Conditions

Patellar Dislocation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Knee Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Juan P Martinez, MD

  Fundacion Clinica Valle del Lili

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan P Martinez, MD

CONTACT

+576023319090; juan.martinez.ca@fvl.org.co

Alejandro Gallego, MD

CONTACT

+576023319090; alejandro.gallego.al@fvl.org.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator and outcomes assessor will not have access to the type of treatment a patient received.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 17, 2023
• Study Start: October 2, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

CO (1)