Subchondral Insufficiency FractureNCT04953702
Study of the Associations Between Subchondral Insufficiency Fractures of the Knee and Pre-existing Health, Lifestyle, and/or Musculoskeletal Conditions
An observational study of Subchondral Insufficiency Fracture, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Subchondral Insufficiency Fracture
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2021to 10 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients diagnosed with SIFK from ages ≥18 years old who seek treatment at the University of Massachusetts for their musculoskeletal care.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Memorial Health
Worcester, Massachusetts, 01655
About this study
Official title: 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.
- Conditions
- Subchondral Insufficiency Fracture
- Keywords
- Exercise, Musculoskeletal diseases, Nutrition disorders, Pain
- Medical subject headings
- Motor Activity, Musculoskeletal Diseases, Nutrition Disorders, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
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).
Measured: 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
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start10 Jun 2021
- Primary completion10 Jun 2024
- Study completion10 Jun 2024
Why it stopped: Not a clinical trial/IRB Approval Lapsed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subchondral Insufficiency FractureStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauren Scarpetti, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953702
- Sponsor's protocol ID
- H00023240
- Status last verified
- Sep 2024
- First submitted
- 11 Jun 2021
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insufficiency Fractures of the Knee: Insufficient of Nutrients or Cartilage?
- ClinicalTrials.gov ID
- NCT04953702
- Acronym / sponsor ID
- H00023240
- Conditions
- Subchondral Insufficiency Fracture
- Keywords
- Exercise, Musculoskeletal diseases, Nutrition disorders, Pain
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Not a clinical trial/IRB Approval Lapsed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients diagnosed with SIFK from ages ≥18 years old who seek treatment at the University of Massachusetts for their musculoskeletal care.
Key exclusion criteria (7 listed)
- Patients with a history of associated conditions such as cancer, inflammatory arthritis, or chronic alcohol or tobacco dependence 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Correlation between type of treatment for subchondral insufficiency fractures (SIFKs) and treatment outcome (pain level)
Time frame: 12 months
Correlation between activity level and treatment outcome (pain level)
Time frame: 12 months
Correlation between coexisting conditions and treatment outcome (pain level)
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Subchondral Insufficiency Fracture
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Enrolling by invitationPhase 2
Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Scarpetti principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subchondral Insufficiency Fracture, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between subchondral insufficiency fractures (SIFKs) and coexisting conditions (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.