Conservative Versus Operative - First Time Patella Dislocations

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Columbia University

Status

Not yet enrolling

Conditions

Patella Dislocation

Treatments

Procedure: Non-operative group
Procedure: medial patellofemoral reconstruction

Study type

Interventional

Funder types

Other

Identifiers

NCT05533671
AAAU0964

Details and patient eligibility

About

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).

Full description

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).

Enrollment

200 estimated patients

Sex

All

Ages

12+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Operative Group
Experimental group
Description:
This group will have surgical procedure called a medial patellofemoral reconstruction where the kneecap is anchored back into its correct position)
Treatment:
Procedure: medial patellofemoral reconstruction
Non-operative group
Active Comparator group
Description:
This group will have physical therapy for their knee dislocation by following a specific rehabilitation plan.
Treatment:
Procedure: Non-operative group

Trial contacts and locations

1

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Central trial contact

Christian A Pearsall, BS, BA

Data sourced from clinicaltrials.gov

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