Surgery vs Rehabilitation for Patellar Dislocation

Overseen By David Trofa, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Coexistent ligament injury, Previous knee surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to treat a first-time kneecap dislocation by comparing two approaches: surgery to reposition the kneecap (Medial Patellofemoral Reconstruction) and physical therapy to strengthen and stabilize the knee. The goal is to determine which method reduces future dislocations and improves patient satisfaction. Participants must have experienced their first kneecap dislocation and be patients of the Columbia University Shoulder Elbow and Sports Medicine Service. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance treatment options for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these treatments are safe for managing patellar dislocation?

A previous study found that reconstructing the medial patellofemoral ligament (MPFL) is a safe and effective treatment for people with recurring kneecap dislocations. Research shows that after this surgery, only about 1% to 6.6% of patients experience another dislocation, indicating that most patients do well post-surgery. Additionally, 84.1% of athletes returned to their previous level of sports activity after the procedure. This suggests that the treatment is generally well-tolerated and effective in helping people resume normal activity levels. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for patellar dislocation because they offer distinct approaches to addressing the condition. The operative group undergoes medial patellofemoral reconstruction, a surgical technique that directly stabilizes the kneecap by anchoring it back into place, offering a potentially more permanent solution compared to traditional methods like bracing or conservative physical therapy. On the other hand, the non-operative group focuses on a structured rehabilitation plan, which emphasizes physical therapy without surgery, catering to patients who prefer non-invasive options. This trial aims to compare these two approaches directly to determine which is more effective for long-term knee stability and function.

What evidence suggests that this trial's treatments could be effective for patellar dislocation?

This trial will compare two treatment approaches for patellar dislocation: surgery and rehabilitation. Research has shown that medial patellofemoral ligament reconstruction, the surgery for participants in the operative group, effectively treats repeated kneecap dislocations. A detailed review found that this surgery is safe and reduces the risk of future dislocations. One study found that the surgery helps patients return to sports at the same or even higher levels than before. Reports from patients suggest a very low chance of the kneecap dislocating again after surgery. Meanwhile, participants in the non-operative group will follow a specific rehabilitation plan focusing on physical therapy, which can be helpful but may not prevent future dislocations as reliably as surgery. ^{1 2 6 7 8}

Who Is on the Research Team?

David Trofa, MD

Principal Investigator

Associate Professor of Orthopaedic Surgery

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Patients seen by the Columbia University Shoulder Elbow and Sports Medicine Service

I have had my kneecap dislocated for the first time.

I am 12 years old or older.

Exclusion Criteria

I have had knee surgery before.

I need immediate surgery for a ligament injury or bone fracture.

Knee instability prior to injury

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either surgical management (medial patellofemoral ligament reconstruction) or non-operative management (standardized rehabilitation protocol) for primary patellar dislocations

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Medial Patellofemoral Reconstruction
• Non-operative Group

Trial Overview 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.

How Is the Trial Designed?

Group I: Operative Group Experimental Treatment 1 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 group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11645772/

Impact of the Number of Patellar Dislocations on Outcomes ... Patients who experience >2 patellar dislocations before MPFL reconstruction would demonstrate poorer patient-reported outcomes (PROs) compared with those with ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2059775425006145

How much Improvement in Patient Reported Outcomes ... From a surgeon's perspective, a satisfactory outcome after isolated MPFL-R was defined as the ability to return to sports at the same or higher ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37531844/

Isolated medial patellofemoral reconstruction outcomes This systematic review and meta-analysis demonstrates that isolated MPFL reconstruction is a safe and effective treatment for recurrent patellar dislocations.

4. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/138208-a-landscape-of-recent-literature-on-the-predictors-of-success-and-failure-in-medial-patellofemoral-ligament-reconstruction

A Landscape of Recent Literature on the Predictors of ... The aim of this review is to identify the factors that predict both the success and failure of MPFL reconstruction in the treatment of patellofemoral ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666061X22001869

Patient-Reported Outcomes Following Medial ... The very low risk of recurrent patellar dislocation (0%) compares favorably with the 1% to 2% failure risk of both isolated MPFL reconstructions and several ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2214963520300936

Five-years outcome of medial patellofemoral ligament ... A prospective analysis of MPFL reconstruction patient's data reported that 84.1% of athletes returned to their previous level of sports participation, with only ...

7. arthroscopytechniques.org arthroscopytechniques.org/article/S2212-6287(25)00226-9/fulltext

Physeal-Sparing Medial Patellofemoral Ligament ... Recurrent instability rates after primary dislocation range from 15% to 70%. ... A careful balance between the bony articulations of the ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5502077/

Outcomes After Isolated Medial Patellofemoral Ligament ... Recent reviews by Tompkins and Arendt and Matic et al have reported redislocation and failure rates of 1% and 6.6%, respectively, after MPFL reconstruction.