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

Recruiting

• Conditions: Subchondral Insufficiency Fracture

• Registration Number: NCT04953702
• Lead Sponsor: Tomer Korabelnikov

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-10
• Study First Submitted: 2021-06-11
• Study First Submitted QC: 2021-06-28
• Study First Posted: 2021-07-08
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-08
• Last Update Posted: 2023-10-10
• Primary Completion: 2024-06-10
• Study Completion: 2024-06-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between subchondral insufficiency fractures (SIFKs) and coexisting conditions	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Correlation between type of treatment for subchondral insufficiency fractures (SIFKs) and treatment outcome (pain level)	12 months	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).
Correlation between activity level and treatment outcome (pain level)	12 months	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
Correlation between coexisting conditions and treatment outcome (pain level)	12 months	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.

Trial Locations

Locations (1)

University of Massachusetts Memorial Health; 🇺🇸 Worcester, Massachusetts, United States