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Conservativo contro operativo - Lussazioni rotulee per la prima volta

16 settembre 2026 aggiornato da: Columbia University

Gestione conservativa e chirurgica delle lussazioni rotulee per la prima volta

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).

Panoramica dello studio

Descrizione dettagliata

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).

Tipo di studio

Interventistico

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

12 anni e precedenti (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • age 12 and older
  • patients seen by the Columbia University Shoulder Elbow and Sports Medicine Service
  • patients who experience a first-time patella dislocation

Exclusion Criteria:

  • coexistent ligament injury or osteochondral fracture necessitating acute surgical intervention
  • previous knee surgery
  • knee instability prior to injury
  • inability or unwillingness to adhere to study participate
  • lost to follow up

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Operative Group

This group will have surgical procedure called a medial patellofemoral reconstruction where the kneecap is anchored back into its correct position)

Surgery to correct dislocated (knocked out of place) knee cap. This surgery anchors the kneecap back into the correct position and supports the kneecap.

Comparatore attivo: Non-operative group

This group will have physical therapy for their knee dislocation by following a specific rehabilitation plan.

Physical therapy by following a specific regimen.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Kujala Questionnaire Score at 2 weeks
Lasso di tempo: Baseline and 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.

Baseline and 2 weeks
Change in Kujala Questionnaire Score at 6 weeks
Lasso di tempo: Baseline and 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.

Baseline and 6 weeks
Change in Kujala Questionnaire Score at 3 months
Lasso di tempo: Baseline and 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.

Baseline and 3 months
Change in Kujala Questionnaire Score at 6 months
Lasso di tempo: Baseline and 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.

Baseline and 6 months
Change in Kujala Questionnaire Score at 1 year
Lasso di tempo: Baseline and 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.

Baseline and 1 year
Change in Kujala Questionnaire Score at 2 years
Lasso di tempo: Baseline and 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.

Baseline and 2 years
Change in Kujala Questionnaire Score at 5 years
Lasso di tempo: Baseline and 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.

Baseline and 5 years
Change in Kujala Questionnaire Score at 10 years
Lasso di tempo: Baseline and 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.

Baseline and 10 years
Time to first re-dislocation
Lasso di tempo: Up to 10 years

Time to first re-dislocation following intervention, measured in weeks

Up to 10 years

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 2 weeks
Lasso di tempo: Baseline and 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.

Baseline and 2 weeks
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 6 weeks
Lasso di tempo: Baseline and 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.

Baseline and 6 weeks
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 3 months
Lasso di tempo: Baseline and 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.

Baseline and 3 months
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 6 months
Lasso di tempo: Baseline and 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.

Baseline and 6 months
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 1 year
Lasso di tempo: Baseline and 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.

Baseline and 1 Year
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 2 years
Lasso di tempo: Baseline and 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.

Baseline and 2 Years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 5 years
Lasso di tempo: Baseline and 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.

Baseline and 5 Years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 10 years
Lasso di tempo: Baseline and 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.

Baseline and 10 Years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 2 weeks
Lasso di tempo: Baseline and 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.

Baseline and 2 weeks
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 6 weeks
Lasso di tempo: Baseline and 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.

Baseline and 6 weeks
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 3 Months
Lasso di tempo: Baseline and 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.

Baseline and 3 Months
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 6 Months
Lasso di tempo: Baseline and 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.

Baseline and 6 Months
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 1 Year
Lasso di tempo: Baseline and 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.

Baseline and 1 Year
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 2 Years
Lasso di tempo: Baseline and 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.

Baseline and 2 Years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 5 Years
Lasso di tempo: Baseline and 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.

Baseline and 5 Years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 10 Years
Lasso di tempo: Baseline and 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.

Baseline and 10 Years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 2 weeks
Lasso di tempo: Baseline and 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.

Baseline and 2 weeks
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 6 weeks
Lasso di tempo: Baseline and 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.

Baseline and 6 weeks
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 3 months
Lasso di tempo: Baseline and 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.

Baseline and 3 months
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 6 months
Lasso di tempo: Baseline and 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.

Baseline and 6 months
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 1 year
Lasso di tempo: Baseline and 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.

Baseline and 1 year
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 2 years
Lasso di tempo: Baseline and 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.

Baseline and 2 years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 5 years
Lasso di tempo: Baseline and 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.

Baseline and 5 years
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 10 years
Lasso di tempo: Baseline and 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.

Baseline and 10 years
Percentage of participants who re-dislocate their knee after treatment at each time point within each group
Lasso di tempo: 2 weeks 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years

Percentage of group that experienced re-dislocation after treatment starts at each time point

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
Lasso di tempo: Up to 10 years

Time from treatment initiation to full return to pre-injury activity levels in each group, measured in weeks

Up to 10 years
Change in the Banff Patella Instability Instrument at 2 weeks
Lasso di tempo: Baseline and 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.

Baseline and 2 weeks
Change in the Banff Patella Instability Instrument at 6 weeks
Lasso di tempo: Baseline and 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.

Baseline and 6 weeks
Change in the Banff Patella Instability Instrument at 3 months
Lasso di tempo: Baseline and 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.

Baseline and 3 months
Change in the Banff Patella Instability Instrument at 6 months
Lasso di tempo: Baseline and 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.

Baseline and 6 months
Change in the Banff Patella Instability Instrument at 1 year
Lasso di tempo: Baseline and 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.

Baseline and 1 year
Change in the Banff Patella Instability Instrument at 2 years
Lasso di tempo: Baseline and 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.

Baseline and 2 years
Change in the Banff Patella Instability Instrument at 5 years
Lasso di tempo: Baseline and 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.

Baseline and 5 years
Change in the Banff Patella Instability Instrument at 10 years
Lasso di tempo: Baseline and 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.

Baseline and 10 years
Change in Norwich Patellar Instability Score at 2 weeks
Lasso di tempo: Baseline and 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.

Baseline and 2 weeks
Change in Norwich Patellar Instability Score at 6 weeks
Lasso di tempo: Baseline and 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.

Baseline and 6 weeks
Change in Norwich Patellar Instability Score at 3 months
Lasso di tempo: Baseline and 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.

Baseline and 3 months
Change in Norwich Patellar Instability Score at 6 months
Lasso di tempo: Baseline and 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.

Baseline and 6 months
Change in Norwich Patellar Instability Score at 1 year
Lasso di tempo: Baseline and 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.

Baseline and 1 year
Change in Norwich Patellar Instability Score at 2 years
Lasso di tempo: Baseline and 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.

Baseline and 2 years
Change in Norwich Patellar Instability Score at 5 years
Lasso di tempo: Baseline and 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.

Baseline and 5 years
Change in Norwich Patellar Instability Score at 10 years
Lasso di tempo: Baseline and 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.

Baseline and 10 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: David Trofa, MD, Associate Professor of Orthopaedic Surgery

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 settembre 2032

Completamento dello studio (Stimato)

1 settembre 2032

Date di iscrizione allo studio

Primo inviato

4 settembre 2022

Primo inviato che soddisfa i criteri di controllo qualità

7 settembre 2022

Primo Inserito (Effettivo)

9 settembre 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • AAAU0964

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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