Operative Group for Patella Dislocation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Columbia University Irving Medical Center, New York, NY
Patella Dislocation+2 More
medial patellofemoral reconstruction - Procedure
Eligibility
Any Age
All Sexes
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Study Summary

There is no consensus regarding whether rehabilitation or surgical management is best for the management of a primary patellar dislocation. Consequently this prospective randomized controlled aims to compare the incidence of recurrent knee dislocations and patient reported outcomes of patients with primary patellar dislocations managed with surgery (medial patellofemoral ligament reconstruction) compared to non-operative management (a standardized rehabilitation protocol, control group).

Eligible Conditions

  • Patella Dislocation

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

9 Primary · 42 Secondary · Reporting Duration: Up to 10 years

Year 10
Percentage of participants who re-dislocate their knee after treatment at each time point within each group
Baseline and 1 Year
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 1 year
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 1 Year
Baseline and 1 year
Change in Kujala Questionnaire Score at 1 year
Change in Norwich Patellar Instability Score at 1 year
Change in the Banff Patella Instability Instrument at 1 year
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 1 year
Baseline and 10 Years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 10 years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 10 Years
Baseline and 10 years
Change in Kujala Questionnaire Score at 10 years
Change in Norwich Patellar Instability Score at 10 years
Change in the Banff Patella Instability Instrument at 10 years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 10 years
Baseline and 2 Years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 2 years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 2 Years
Baseline and 2 weeks
Change in Kujala Questionnaire Score at 2 weeks
Change in Norwich Patellar Instability Score at 2 weeks
Change in the Banff Patella Instability Instrument at 2 weeks
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 2 weeks
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 2 weeks
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 2 weeks
Baseline and 2 years
Change in Kujala Questionnaire Score at 2 years
Change in Norwich Patellar Instability Score at 2 years
Change in the Banff Patella Instability Instrument at 2 years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 2 years
Baseline and 3 Months
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 3 Months
Baseline and 3 months
Change in Kujala Questionnaire Score at 3 months
Change in Norwich Patellar Instability Score at 3 months
Change in the Banff Patella Instability Instrument at 3 months
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 3 months
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 3 months
Baseline and 5 Years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 5 years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 5 Years
Baseline and 5 years
Change in Kujala Questionnaire Score at 5 years
Change in Norwich Patellar Instability Score at 5 years
Change in the Banff Patella Instability Instrument at 5 years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 5 years
Baseline and 6 Months
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 6 Months
Baseline and 6 months
Change in Kujala Questionnaire Score at 6 months
Change in Norwich Patellar Instability Score at 6 months
Change in the Banff Patella Instability Instrument at 6 months
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 6 months
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 6 months
Baseline and 6 weeks
Change in Kujala Questionnaire Score at 6 weeks
Change in Norwich Patellar Instability Score at 6 weeks
Change in the Banff Patella Instability Instrument at 6 weeks
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 6 weeks
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 6 weeks
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 6 weeks
Up to 10 years
Time to first re-dislocation
Time to return to full activity or sports for each group

Trial Safety

Trial Design

2 Treatment Groups

Non-operative group
1 of 2
Operative Group
1 of 2
Active Control
Experimental Treatment

200 Total Participants · 2 Treatment Groups

Primary Treatment: Operative Group · No Placebo Group · N/A

Operative Group
Procedure
Experimental Group · 1 Intervention: medial patellofemoral reconstruction · Intervention Types: Procedure
Non-operative group
Procedure
ActiveComparator Group · 1 Intervention: Non-operative group · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 10 years

Trial Background

Prof. David P. Trofa, MD
Principal Investigator
Columbia University
Closest Location: Columbia University Irving Medical Center · New York, NY
Photo of New York  1Photo of New York  2Photo of New York  3
2002First Recorded Clinical Trial
1 TrialsResearching Patella Dislocation
70 CompletedClinical Trials

Eligibility Criteria

Age Any Age · All Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References