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Procedure

Surgery vs Rehabilitation for Patellar Dislocation

N/A

Waitlist Available

Led By David Trofa, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

Study Summary

This trial aims to compare the outcomes of surgery and rehabilitation for people with a primary patellar dislocation.

Who is the study for?

This trial is for individuals aged 12 or older who have experienced a first-time patella (kneecap) dislocation and are seen by the Columbia University Shoulder Elbow and Sports Medicine Service. It's not for those with other knee injuries needing urgent surgery, past knee surgeries, pre-injury instability, or if they can't commit to the study.Check my eligibility

What is being tested?

The study compares two approaches after a first-time kneecap dislocation: surgical reconstruction of the medial patellofemoral ligament versus non-surgical treatment involving standardized rehabilitation. The goal is to see which method better prevents further dislocations and improves patient outcomes.See study design

What are the potential side effects?

Potential side effects from surgery may include pain, infection, stiffness, or complications related to anesthesia. Non-operative treatment risks might involve less optimal recovery of joint stability leading to potential re-dislocations.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Kujala Questionnaire Score at 1 year

Change in Kujala Questionnaire Score at 10 years

Change in Kujala Questionnaire Score at 2 weeks

+6 more

Secondary outcome measures

Change in Norwich Patellar Instability Score at 1 year

Change in Norwich Patellar Instability Score at 10 years

Change in Norwich Patellar Instability Score at 2 weeks

+39 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Operative GroupExperimental Treatment1 Intervention

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

Group II: Non-operative groupActive Control1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,431 Previous Clinical Trials

2,460,633 Total Patients Enrolled

David Trofa, MDPrincipal InvestigatorAssistant Professor of Orthopedic Surgery

2 Previous Clinical Trials

400 Total Patients Enrolled

Media Library

Medial Patellofemoral Reconstruction (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05533671 — N/A

Patellar Dislocation Research Study Groups: Non-operative group, Operative Group

Patellar Dislocation Clinical Trial 2023: Medial Patellofemoral Reconstruction Highlights & Side Effects. Trial Name: NCT05533671 — N/A

Medial Patellofemoral Reconstruction (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05533671 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still spaces available for participants in this research endeavor?

"This trial, as reflected on clinicaltrials.gov, is not actively recruiting patients at this time; the study was first uploaded on September 1st 2022 and last updated nine days later. However, there are presently 37 other medical studies that are accepting participants."

Answered by AI

What are the desired results of this research endeavor?

"The primary measure of this clinical trial, to be monitored at Baseline and 6 months is the Change in Kujala Questionnaire Score after 5 years. Secondary outcomes include a shift in Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT), expressed as a T-score with an average score of 50 and 10 standard deviations, Norwich Patellar Instability Score reported as a percentage over five years, and Banff Patella Instability Instrument evaluated two weeks post intervention being rated on a 0-100 scale with higher scores representing favourable results."

Answered by AI

Recent research and studies

Orthopaedic Journal of Sports MedicineJournal

Medial Patellofemoral Ligament Reconstruction for Patellar Dislocation

Mackay, Nicola D., Nicholas A. Smith, Nick Parsons, Tim Spalding, Peter Thompson, and Andrew P. Sprowson. 2014. “Medial Patellofemoral Ligament Reconstruction for Patellar Dislocation”. Orthopaedic Journal of Sports Medicine. SAGE Publications. doi:10.1177/2325967114544021.

International OrthopaedicsJournal

Surgical Medial Patellofemoral Ligament Reconstruction Versus Non-surgical Treatment of Acute Primary Patellar Dislocation: A Prospective Controlled Trial

Zheng, Xiaozuo, Yang Hu, Peng Xie, Meijuan Cui, Xuelin Ma, Yu-e Feng, Juyuan Gu, and Shijun Gao. 2018. “Surgical Medial Patellofemoral Ligament Reconstruction Versus Non-surgical Treatment of Acute Primary Patellar Dislocation: A Prospective Controlled Trial”. International Orthopaedics. Springer Science and Business Media LLC. doi:10.1007/s00264-018-4243-x.

Journal of Orthopaedic Surgery and ResearchJournal

Does Surgical Treatment Produce Better Outcomes Than Conservative Treatment for Acute Primary Patellar Dislocations? A Meta-analysis of 10 Randomized Controlled Trials

Xing, Xuewu, Hongyu Shi, and Shiqing Feng. 2020. “Does Surgical Treatment Produce Better Outcomes Than Conservative Treatment for Acute Primary Patellar Dislocations? A Meta-analysis of 10 Randomized Controlled Trials”. Journal of Orthopaedic Surgery and Research. Springer Science and Business Media LLC. doi:10.1186/s13018-020-01634-5.

Orthopaedic Journal of Sports MedicineJournal