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Repair of Medial Patellofemoral Ligament Compared to Conservative Treatment for First Time Patella Dislocation

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ClinicalTrials.gov Identifier: NCT02185001
Recruitment Status : Terminated (Inadequate patient recruitment and coordinator left organization)
First Posted : July 9, 2014
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Orthopedic Specialty Institute

Brief Summary:

Background: The forces involved in a patella dislocation event can cause significant collateral damage involving the articular cartilage of the patella femoral joint. As a result, prevention of recurrent patella dislocation and the associated disability and morbidity has generated significant interest in the orthopedic community. Historically, nonoperative treatment for first time patella dislocation has been problematic due to high redislocation rates. Nonoperative protocols generally involve bracing and/or immobilization, followed by physical therapy (1). Surgical approaches to recurrent patella dislocation, both soft tissue and boney realignment operations, have also had mixed results, including low success rates, associated complications, and variable rates of return to functional activity (2,3,4). This study is intended to compare the outcomes of a relatively low-risk Medial Patellofemoral Ligament (MPFL) direct repair procedure to conservative treatment.

Methods/Design: This study is designed as a two arm randomized prospective trial. Approximately fifty subjects will be randomly assigned to either a surgical or non-operative arm by means of a computer randomized allocation program. All subjects will have X-Ray Images and Magnetic Resonance Imaging (MRI) to determine the site of the MPFL damage, and to determine if any excluding conditions exist. Subjects randomized to the surgical group will have repair of the MPFL. Routine aftercare will consist of physical therapy in a clinic that has agreed to follow our protocol. Subjects randomized to the nonoperative group will receive 2 weeks of patellar immobilization, followed by patellar stabilization bracing with physical therapy for approximately 12 weeks. Physical therapy will progress through five phases with the goal of gait normalization, full range of motion and return to sport. Both arms will be given outcome questionnaires and physical activity assessments before treatment, and at one, three, six, twelve, and twenty four month intervals.

Discussion: This prospective randomized trial will investigate the results of direct repair of the medial patellofemoral ligament and conservative treatment by applying subjective outcome measures (Kujala scores), and exam findings to determine MPFL functional restoration or redislocation. Subjects will be examined in the clinic setting at 10 days, one month, and six months post trauma. Any reported recurrent dislocation or subluxation event will be documented during recovery. All subjects will receive merchant x-ray views at 3 months with manual lateral translation of the patella.


Condition or disease Intervention/treatment Phase
Dislocated Patella Torn Medial Patellofemoral Ligament Procedure: Direct Medial Patellofemoral Ligament (MPFL) Repair Procedure: Physical therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Repair of Medial Patellofemoral Ligament Compared to Conservative Treatment for First Time Patella Dislocation; A Randomized Prospective Trial
Study Start Date : October 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dislocations

Arm Intervention/treatment
Active Comparator: Surgical Treatment Group
Direct Medial Patellofemoral Ligament (MPFL) Repair
Procedure: Direct Medial Patellofemoral Ligament (MPFL) Repair
The MPFL will be repaired directly at the site of the traumatic injury.
Other Name: Surgical Treatment Group

Active Comparator: Conservative Treatment Group
Immobilization, stabilization bracing, and physical therapy
Procedure: Physical therapy
Patellar immobilization, stabilization, and strengthening under the direction and guidance of the physician and physical therapist.
Other Name: Physiotherapy




Primary Outcome Measures :
  1. Patient Reported Change in Patellar Stability, Subluxation, or Recurrent Dislocation. [ Time Frame: 24 months, or as reported by subject ]

    Subjects will be divided into 3 groups relating to patellar stability:

    1. Recurrence, indicating that the patient had a recurrent patellofemoral dislocation (total loss of congruence between the patella and trochlea) prior to 24 months.
    2. Unstable, indicating that the patient's knee presented with a positive apprehension test or showed signs of subluxation prior to 24 months, but without recurrent dislocation.
    3. Stable, indicating that the patient's knee did not show positive signs of episodes of subluxation at 24 months.


Secondary Outcome Measures :
  1. Subjective Outcome Measurement (Kujala Test) [ Time Frame: 1, 3, 6, 12, and 24 months ]
    Patients will be asked to complete the Kujala knee pain questionnaire to record pain and function levels at various points in the study.



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • A first patellofemoral traumatic dislocation
  • A need for reduction
  • An absence of fractures on x-ray exam of the frontal and lateral knee and axial patella
  • An absence of knee ligament lesions with surgical indications (with the exception of the MPFL)
  • No previous knee surgery

Exclusion criteria:

  • A prior episode of patellofemoral dislocation
  • Fractures on x-ray exam of the frontal and lateral knee and axial patella Prior surgery on the knee
  • Tibial tuberosity-trochlear groove distance greater than 20mm
  • Current pregnancy or plan to become pregnant during the study period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02185001


Locations
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United States, Idaho
The Lyman Knee Clinic
Coeur d'Alene, Idaho, United States, 83814
Sponsors and Collaborators
Orthopedic Specialty Institute
Investigators
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Principal Investigator: Jeffrey R Lyman, MD Orthopedic Specialty Institute

Publications:

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Responsible Party: Orthopedic Specialty Institute
ClinicalTrials.gov Identifier: NCT02185001     History of Changes
Other Study ID Numbers: TLKC-0001
First Posted: July 9, 2014    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Orthopedic Specialty Institute:
Medial patellofemoral ligament
MPFL
Repair
Patellar dislocation
Knee

Additional relevant MeSH terms:
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Joint Dislocations
Patellar Dislocation
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Knee Injuries
Leg Injuries