Patellar DislocationNCT06086080
Non-operative Treatment in First-time Patellar Dislocation
A study testing Taping in people with Patellar Dislocation, run by Fundacion Clinica Valle del Lili at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 40 years
- Conditions the study is for
- Patellar Dislocation
- What is being tested?
- Taping
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteColombia
- Study dates
- 2 Oct 2023to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with first episode of acute lateral patellar dislocation during the last 7 days.
Who cannot join
- Patients with acute bilateral patellar dislocation.
- Patients with open patellar dislocation.
- Patients with previous knee surgery in the same knee.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Fundación Valle del Lili
Cali, Valle del Cauca Department, 760032
Alejandro Gallego, MD, +576023319090, alejandro.gallego.al@fvl.org.co
About this study
Official title: Non-operative Treatment in First-time Patellar Dislocation: a Randomized Controlled 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.
Read the 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:
- Standard treatment (2-weeks with a knee brace) and physical therapy
- 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
- Patellar Dislocation
- Being tested
- Standard care, Taping, Sham taping
- Keywords
- Patellar dislocation, Brace, Knee taping
- Medical subject headings
- Patellar Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard careOther
Bracing and physical therapy
TapingOther
The patient is treated with tape in special configuration (McConell modified) for the patella + standard care
Sham tapingDevice
Taping with no treatment disposition
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Standard care: knee brace for 2 weeks, physical therapy, sham taping (2-weeks) Receives: Other: Standard care; Device: Sham taping |
| Intervention group | Experimental | Knee taping for 4-weeks, knee brace for 1 week, physical therapy Receives: Other: Standard care; Other: Taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent patellar dislocation (percentage of patients)
Percentage of patients with additional patellar dislocation after the first episode
Measured: 2 years
Secondary outcomes (2)
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.
Measured: 2 years
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%.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start2 Oct 2023
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellar DislocationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinica Valle del Lili
- Sponsor type
- University, hospital or other
- Collaborators
- International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine
- Responsible party
- Sponsor
- Investigators
- Juan P Martinez, MD, Principal investigator, Fundacion Clinica Valle del Lili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086080
- Sponsor's protocol ID
- 1906
- Status last verified
- Mar 2025
- First submitted
- 3 Oct 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-operative Treatment in First-time Patellar Dislocation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06086080
- Acronym / sponsor ID
- 1906
- Conditions
- Patellar Dislocation
- Keywords
- Patellar dislocation, Brace, Knee taping
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fundacion Clinica Valle del LiliUniversity, hospital or other
- Collaborators
- International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Standard treatment (2-weeks with a knee brace) and physical therapy
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Standard care, Device: Sham tapingStandard care: knee brace for 2 weeks, physical therapy, sham taping (2-weeks) |
| Intervention group | Experimental | Other: Standard care, Other: TapingKnee taping for 4-weeks, knee brace for 1 week, physical therapy |
Who may qualify
- Ages
- 10 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with first episode of acute lateral patellar dislocation during the last 7 days.
Key exclusion criteria (3 listed)
- Patients with acute bilateral patellar dislocation.
- Patients with open patellar dislocation.
- Patients with previous knee surgery in the same knee.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard careBracing and physical therapy | Other | Control group, Intervention group |
| TapingThe patient is treated with tape in special configuration (McConell modified) for the patella + standard care | Other | Intervention group |
| Sham tapingTaping with no treatment disposition | Device | Control group |
Primary outcome
Recurrent patellar dislocation (percentage of patients)
Time frame: 2 years
Percentage of patients with additional patellar dislocation after the first episode
2 secondary outcomes
Banff Patellofemoral Instability Instrument (BPII)
Time frame: 2 years
Nich patellar instability (NPI) score
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: Yes. All individual participant data that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juan P Martinez, MD principal investigator
Fundacion Clinica Valle del Lili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taping in people with Patellar Dislocation, run by Fundacion Clinica Valle del Lili at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan P Martinez, MD (+576023319090, juan.martinez.ca@fvl.org.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent patellar dislocation (percentage of patients) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.