Study of the Associations Between Subchondral Insufficiency Fractures of the Knee and Pre-existing Health, Lifestyle, and/or Musculoskeletal Conditions

Study Overview
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Brief Summary
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This prospective cohort study is designed to investigate possible association(s) between subchondral insufficiency fractures (SIFKs) of the knee and pre-existing health, lifestyle, and/or musculoskeletal conditions. In doing so, this research may shed light on the underlying cause(s) of SIFKs. It is hypothesized that SIFKs of the knee are related to osteoarthritis, weak bone, and/or metabolic issues, rather than trauma.

Official Title
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Insufficiency Fractures of the Knee: Insufficient of Nutrients or Cartilage?

Conditions
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Subchondral Insufficiency Fracture

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with SIFK from ages ≥18 years old who seek treatment at the University of Massachusetts for their musculoskeletal care. Exclusion Criteria: Patients with a history of associated conditions such as cancer, inflammatory arthritis, or chronic alcohol or tobacco dependence will be excluded. The following special populations will be excluded: Adults unable to consent and/or unable to follow two-step commands Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners Non-English-speaking patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between subchondral insufficiency fractures (SIFKs) and coexisting conditions | The proportion of patients with subchondral insufficiency fractures and coexisting conditions (overall and per condition) as compared to those without coexisting conditions. Coexisting conditions are identified and defined through metabolic and musculoskeletal-related findings from available lab and radiological results in the patient medical record, such as those related to diabetes, obesity, osteoarthritis and other orthopedic related conditions and metabolic issues. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between type of treatment for subchondral insufficiency fractures (SIFKs) and treatment outcome (pain level) | The proportions of patients with improvement in pain, worsening of pain, or no change in pain per prescribed treatment. Changes in pain level identified by visual analog scale (VAS) and three-point scale (same/better/worse). The VAS includes subject identification of pain level from 0 (no pain) to 10 (worst pain). Change in pain level identified via VAS in evaluating numerical assessment provided by subjects over course of treatment (increase in rank = worsening; decrease in rank = improving; same rank = same). Change in pain level identified directly using the three point scale (same/better/worse). | 12 months | 
| Correlation between activity level and treatment outcome (pain level) | The proportions of patients with improvement in pain, worsening of pain, or no change in pain based on activity level. Changes in pain level identified by visual analog scale (VAS) and three-point scale (same/better/worse). The VAS includes subject identification of pain level from 0 (no pain) to 10 (worst pain). Change in pain level identified via VAS in evaluating numerical assessment provided by subjects over course of treatment (increase in rank = worsening; decrease in rank = improving; same rank = same). Change in pain level identified directly using the three point scale (same/better/worse). Activity level collected via interviews (exercise type/duration/frequency). Activity level categorized into none/mild/moderate/high exertion based on the following criteria: MILD=pool, chair yoga, golf w/ cart MODERATE=land-based exercise/standing/walking/cycling, golf w/out cart HIGH=can't talk while exercising, running/cycling>10miles, jumping, boot camp | 12 months | 
| Correlation between coexisting conditions and treatment outcome (pain level) | The proportions of patients with improvement in pain, worsening of pain, or no change in pain based on presence or absence of coexisting conditions (overall, per condition). Changes in pain level identified by visual analog scale (VAS) and three-point scale (same/better/worse). The VAS includes subject identification of pain level from 0 (no pain) to 10 (worst pain). Change in pain level identified via VAS in evaluating numerical assessment provided by subjects over course of treatment (increase in rank = worsening; decrease in rank = improving; same rank = same). Change in pain level identified directly using the three point scale (same/better/worse). Coexisting conditions identified and defined through metabolic and MSK-related findings from available lab and radiological results in the medical record, such as those related to diabetes, obesity, osteoarthritis and other orthopedic related and metabolic issues. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Musculoskeletal diseases, Nutrition disorders, Pain