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Completed

NCT Number: NCT02016300

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

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.

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Key information

Conditions

Cartilage Loss Fractures, Bone Fractures, Stress Microfracture Wounds and Injuries

Age range

15 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University Medical Center

Redwood City, California, 94063, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unloader Bracing

Device

The bracing arm patients will be randomly selected and will wear an unloader brace post-operatively during the study period.

Other names: Ossur Unloader Brace

Non-Bracing

Device

Microfracture performed with no post-operative unloader bracing

Primary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome)

    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. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.

Secondary outcomes

  1. Change From Baseline in Tegner Score (Clinical Outcome)

    Time frame: 2 years

    The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury. A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports. A score >6 can only be achieved if the person participates in recreational or competitive sport.

  2. Change From Baseline in SF-12 Quality of Life Score (Clinical Outcome)

    Time frame: 2 years

    SF-12 scale is a generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey which, when combined, scored and weighted, results in two scales of mental and physical functioning and overall health-related quality of life. A higher value indicates a better quality of life of the patient. The scores range from 0 to 100.

  3. Change From Baseline in Lysholm Score (Clinical Outcome)

    Time frame: 2 years

    The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function.

  4. Change From Baseline in T2 Relaxation Time (Radiographic Outcome)

    Time frame: 2 years

    T2 imaging assesses hydration of cartilage as well as collagen fiber orientation and loss of type II collagen.

  5. Change From Baseline in Cartilage Volume (Radiographic Outcome)

    Time frame: 2 years

  6. Change From Baseline in Cartilage Thickness (Radiographic Outcome)

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Effects of Unloader Bracing in Clinical Outcome and Articular Cartilage Physiology Following Microfracture of Isolated Chondral Defects

Acronym: Mfxbracing

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Dec 19, 2013
Registry last updated
Jun 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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