An interventional study of medial patellofemoral reconstruction and Non-operative group in Patella Dislocation, sponsored by Columbia University. Withdrawn. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Columbia University · Not applicable, Interventional, and Treatment
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).
Long term sequalae of first-time patellar dislocations include recurrent knee instability, osteoarthritis, and a decreased quality of life, and yet there is no consensus on the best management for these patients. Despite an increasing trend toward investigating operative vs non-operative management of primary patellar dislocations, scarce level-1 evidence exists comparing the two treatment modalities. Indeed, the few meta-analyses suggesting improved outcomes of operative treatment for first time patellar dislocations mainly utilize retrospective cohort studies. A randomized-controlled trial of 39 patients with primary patellar dislocations with a mean age of 24 (21 operative vs 18 non-operative), found decreased rates of recurrent knee instability after a mean follow up of 44 months (0% in operative vs 35% in non-operative), and a higher Kujala knee score (88.9 in operative vs 70.8 in non-operative; p=0.001). A controlled but non-randomized prospective controlled trial among 69 patients with a mean age of 18, (30 operative vs 39 non-operative), found lower rates of recurrent knee instability after a mean follow up of 24 months (0% in operative vs 20.5% in non-operative and a higher Kujala knee score (86.3 in operative group vs 80.03 in non-operative; p \<0.05).The scarce randomized, prospective data investigating the appropriate management in primary patellar dislocations underscores the importance of the current study in providing high-quality evidence to the debate of how to best manage primary patellar dislocations. This study 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).
41 studies on the registry are indexed under Patellar Dislocation; 9 are open to participants now.
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Exclusion Criteria:
This group will have surgical procedure called a medial patellofemoral reconstruction where the kneecap is anchored back into its correct position)
Procedure: medial patellofemoral reconstruction
This group will have physical therapy for their knee dislocation by following a specific rehabilitation plan.
Procedure: Non-operative group
Surgery to correct dislocated (knocked out of place) knee cap. This surgery anchors the kneecap back into the correct position and supports the kneecap.
Physical therapy by following a specific regimen.
Change in Kujala Questionnaire Score at 2 weeks
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Time frame: Baseline and 2 weeks
Change in Kujala Questionnaire Score at 6 weeks
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Time frame: Baseline and 6 weeks
Change in Kujala Questionnaire Score at 3 months
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Time frame: Baseline and 3 months
Change in Kujala Questionnaire Score at 6 months
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Time frame: Baseline and 6 months
Change in Kujala Questionnaire Score at 1 year
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Time frame: Baseline and 1 year
Change in Kujala Questionnaire Score at 2 years
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Time frame: Baseline and 2 years
Change in Kujala Questionnaire Score at 5 years
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Time frame: Baseline and 5 years
Change in Kujala Questionnaire Score at 10 years
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Time frame: Baseline and 10 years
Time to first re-dislocation
Time to first re-dislocation following intervention, measured in weeks
Time frame: Up to 10 years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 2 weeks
A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.
Time frame: Baseline and 2 weeks
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 6 weeks
A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.
Time frame: Baseline and 6 weeks
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 3 months
A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.
Time frame: Baseline and 3 months
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 6 months
A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.
Time frame: Baseline and 6 months
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 1 year
A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.
Time frame: Baseline and 1 Year
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 2 years
A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.
Time frame: Baseline and 2 Years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 5 years
A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.
Time frame: Baseline and 5 Years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 10 years
A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.
Time frame: Baseline and 10 Years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 2 weeks
A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.
Time frame: Baseline and 2 weeks
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 6 weeks
A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.
Time frame: Baseline and 6 weeks
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 3 Months
A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.
Time frame: Baseline and 3 Months
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 6 Months
A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.
Time frame: Baseline and 6 Months
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 1 Year
A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.
Time frame: Baseline and 1 Year
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 2 Years
A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.
Time frame: Baseline and 2 Years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 5 Years
A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.
Time frame: Baseline and 5 Years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 10 Years
A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.
Time frame: Baseline and 10 Years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 2 weeks
A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.
Time frame: Baseline and 2 weeks
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 6 weeks
A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.
Time frame: Baseline and 6 weeks
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 3 months
A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.
Time frame: Baseline and 3 months
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 6 months
A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.
Time frame: Baseline and 6 months
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 1 year
A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.
Time frame: Baseline and 1 year
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 2 years
A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.
Time frame: Baseline and 2 years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 5 years
A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.
Time frame: Baseline and 5 years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 10 years
A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.
Time frame: Baseline and 10 years
Percentage of participants who re-dislocate their knee after treatment at each time point within each group
Percentage of group that experienced re-dislocation after treatment starts at each time point
Time frame: 2 weeks 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
Time to return to full activity or sports for each group
Time from treatment initiation to full return to pre-injury activity levels in each group, measured in weeks
Time frame: Up to 10 years
Change in the Banff Patella Instability Instrument at 2 weeks
Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.
Time frame: Baseline and 2 weeks
Change in the Banff Patella Instability Instrument at 6 weeks
Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.
Time frame: Baseline and 6 weeks
Change in the Banff Patella Instability Instrument at 3 months
Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.
Time frame: Baseline and 3 months
Change in the Banff Patella Instability Instrument at 6 months
Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.
Time frame: Baseline and 6 months
Change in the Banff Patella Instability Instrument at 1 year
Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.
Time frame: Baseline and 1 year
Change in the Banff Patella Instability Instrument at 2 years
Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.
Time frame: Baseline and 2 years
Change in the Banff Patella Instability Instrument at 5 years
Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.
Time frame: Baseline and 5 years
Change in the Banff Patella Instability Instrument at 10 years
Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.
Time frame: Baseline and 10 years
Change in Norwich Patellar Instability Score at 2 weeks
Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.
Time frame: Baseline and 2 weeks
Change in Norwich Patellar Instability Score at 6 weeks
Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.
Time frame: Baseline and 6 weeks
Change in Norwich Patellar Instability Score at 3 months
Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.
Time frame: Baseline and 3 months
Change in Norwich Patellar Instability Score at 6 months
Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.
Time frame: Baseline and 6 months
Change in Norwich Patellar Instability Score at 1 year
Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.
Time frame: Baseline and 1 year
Change in Norwich Patellar Instability Score at 2 years
Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.
Time frame: Baseline and 2 years
Change in Norwich Patellar Instability Score at 5 years
Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.
Time frame: Baseline and 5 years
Change in Norwich Patellar Instability Score at 10 years
Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.
Time frame: Baseline and 10 years
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Plan to share: No
Start is estimated for Sep 2026; primary completion for Sep 2032, 72 months later.
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