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

September 24, 2024 updated by: University of Massachusetts, Worcester

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

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.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Memorial Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with SIFK from ages ≥18 years old who seek treatment at the University of Massachusetts for their musculoskeletal care and are not a member of a special population.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between subchondral insufficiency fractures (SIFKs) and coexisting conditions
Time Frame: 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.
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)
Time Frame: 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).
12 months
Correlation between activity level and treatment outcome (pain level)
Time Frame: 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
12 months
Correlation between coexisting conditions and treatment outcome (pain level)
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Investigators

  • Principal Investigator: Lauren Scarpetti, University of Massachusetts, Worcester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2021

Primary Completion (Actual)

June 10, 2024

Study Completion (Actual)

June 10, 2024

Study Registration Dates

First Submitted

June 11, 2021

First Submitted That Met QC Criteria

June 28, 2021

First Posted (Actual)

July 8, 2021

Study Record Updates

Last Update Posted (Actual)

September 26, 2024

Last Update Submitted That Met QC Criteria

September 24, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H00023240

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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