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Effects of Unloader Bracing in Clinical Outcome and Cartilage Physiology Following Microfracture of Chondral Defects (Mfxbracing)

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ClinicalTrials.gov Identifier: NCT02016300
Recruitment Status : Completed
First Posted : December 19, 2013
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Jason L. Dragoo, Stanford University

Brief Summary:

The study will examine clinical and radiographic outcomes of microfracture surgery (a common technique to address isolated areas of cartilage loss) in the knee used with or without unloader bracing. Randomly selected patients will wear an unloader brace, which is designed to take pressure off the area of the knee which underwent repair, for several weeks after surgery. Our hypothesis is that bracing may improve clinical and or radiographic outcomes.

The surgery performed will be the same for all patients

The length of follow up and schedule of post-operative MRI will be the same for all patients.

The only difference in groups will be presence of absence of brace wear.


Condition or disease Intervention/treatment Phase
Cartilage Loss Microfracture Device: Unloader Bracing Device: Non-Bracing Not Applicable

Detailed Description:

The study will examine clinical and radiographic outcomes of microfracture surgery (a common technique to address isolated areas of cartilage loss) in the knee used with or without unloader bracing. Radiographic outcome will be assessed via MRI scans post-operatively. Randomly selected patients will wear an unloader brace, which is designed to take pressure off the area of the knee which underwent repair, for several weeks after surgery. Our hypothesis is that bracing may improve clinical and or radiographic outcomes.

The surgery performed will be the same for all patients

The length of follow up and schedule of post-operative MRI will be the same for all patients.

The only difference in groups will be presence of absence of brace wear.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Unloader Bracing in Clinical Outcome and Articular Cartilage Physiology Following Microfracture of Isolated Chondral Defects
Actual Study Start Date : January 2013
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Arm Intervention/treatment
Experimental: Unloader Bracing
This group will be randomly selected and assigned to wear an unloader brace post-operatively during the study period.
Device: Unloader Bracing
The bracing arm patients will be randomly selected and will wear an unloader brace post-operatively during the study period.
Other Name: Ossur Unloader Brace

Active Comparator: Non-Bracing Arm
This group will be randomly selected and assigned to wear no brace post-operatively.
Device: Non-Bracing
Microfracture performed with no post-operative unloader bracing




Primary Outcome Measures :
  1. Clinical Outcome, Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 2 years ]
    KOOS is a validated outcome score that evaluates knee symptoms, knee pain, knee use in activities of daily living, function in sport and recreation and knee-related quality of life. Statistical analysis will be applied to data at all time points including pre-operatively, 6 months post-surgery, 1 year post-surgery and 2 years post-surgery.


Secondary Outcome Measures :
  1. Clinical Outcome, Tegner score [ Time Frame: 2 years ]
    Multiple validated clinical outcome scores will be assessed at several points up to two years after surgery. The Tegner score establishes activity levels before and after surgery.

  2. Clinical Outcome, SF-12 score [ Time Frame: 2 years ]
    Multiple validated clinical outcome scores will be assessed at several points up to two years after surgery. The SF-12 score assesses quality of life.

  3. Clinical Outcome, Lysholm Score [ Time Frame: 2 years ]
    Multiple validated clinical outcome scores will be assessed at several points up to two years after surgery. The Lysholm score assesses symptoms with activities of daily living.

  4. Radiographic Outcome, MRI with Quantitative T2 Mapping [ Time Frame: 2 years ]
    MRI will be performed at several time points up to 2 years after surgery. T1 Rho and T2 mapping will be performed at 6 months, 1 year and 2 years after surgery. T2 imaging assesses hydration of cartilage as well as collagen fiber orientation and loss of type II collagen.



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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • isolated chondral defect of medial or lateral femoral condyle 2cm squared or less
  • age 15-40
  • neutral knee alignment

Exclusion Criteria:

  • prior cartilage procedures performed in the same knee
  • other significant knee pathology including meniscus tears, ligament tears or inflammatory arthritis

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): NCT02016300


Locations
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United States, California
Stanford University Medical Center
Redwood City, California, United States, 94063
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Jason Dragoo, MD Stanford University

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Responsible Party: Jason L. Dragoo, Associate Professor of Orthopaedic Surgery, Stanford University
ClinicalTrials.gov Identifier: NCT02016300     History of Changes
Other Study ID Numbers: oss-mfx-2013
First Posted: December 19, 2013    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019

Keywords provided by Jason L. Dragoo, Stanford University:
cartilage
microfracture
knee
bracing

Additional relevant MeSH terms:
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Fractures, Stress
Fractures, Bone
Wounds and Injuries