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CompletedNCT04313621Updated Mar 1, 2023

Management of Lower Limb Apophysitis: A Cross-sectional Study on Long-term Impact on Health Status

An observational study in Lower Limb Apophysitis (Severs, Osgood Schlatter, Sinding-Larsen Johansson), sponsored by Hvidovre University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-01.

Sponsored by Hvidovre University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
1,218
Ages
18 Years to 55 Years
Sex
All
01

Study summary

Lower limb apophysitis cause long-term pain, decrease in function, and can reduce or completely hinder participation in sports and physical activity, yet there is little knowledge on the long-term consequences for health. Our objective with this investigation is to capture self-reported health-status for all adults having been diagnosed with lower limb apophysitis in the period of 1977 to 2020 and compared these data with normative values for the background population. We are therefore conducting a national cross-sectional study based on data from the Danish National Patient Registry. In this protocol we describe, as detailed as possible, the planned methods.

02

Conditions studied

  • Lower Limb Apophysitis (Severs, Osgood Schlatter, Sinding-Larsen Johansson)

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03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Sample size will be of convenience with no pre-determined cut-off for smallest or largest sample of interest, rather, the final sample of respondents will be based on however many have been designated the diagnostic codes and responds to the survey.

Inclusion criteria

  • All patients aged 18-55 having received diagnostics codes pertaining to lower limb apophysitis (Severs, Sinding-Larsen Johansson, Osgood Schlatter) in the years 1977-2020 in Denmark will be eligible to participate.

Exclusion criteria

Exclusion Criteria:

  • Diseased participants will be censored
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
1,218 participants (actual)
Target follow-up
1 Day
Patient registry
Yes
05

What researchers measure

Primary outcomes

  1. Physical and mental health

    SF-12 (Short-form 12 item) health survey

    Time frame: Baseline

Secondary outcomes

  1. Sleep: problems and duration

    Time frame: Baseline

  2. Self-reported level of satisfaction with participation in physical activity and sports

    Tegner activity scale (0-10, 10 being no physical activity) and individual specific specific questions

    Time frame: Baseline

  3. Knee pain

    Evaluated on at 0-100 numerical pain rating scale pertaining (0 being no pain) to the knee or other body parts, and worst pain last week or the last month

    Time frame: Baseline

  4. KOOS subscales

    Knee injury and Osteoarthritis Outcome Score (KOOS) and its 5 subscale each scoring 0-100, with 100 being the no problems.

    Time frame: Baseline

  5. Number of Comorbidities from National Health Survey. and musculoskeletal diagnoses from knee or heel

    Time frame: Baseline

  6. PAS-2

    Physical activtiy scale

    Time frame: Baseline

06

Study locations

1 site
  • Kasper Krommes
    Hvidovre, 2650, Denmark
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References and documents

Individual participant data

Plan to share: Yes — The full dataset, excluding all personal identifiers, will be posted alongside the pre-print when the results have been disseminated.

Supporting information: Study protocol, Icf

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04313621
Lead sponsor
Hvidovre University Hospital
Responsible party
Kasper Krommes (Clinical Research Coordinator, PhD-fellow, Physiotherapist, MSc, Hvidovre University Hospital) — Principal investigator
First posted
Mar 18, 2020
Start date
Apr 8, 2021
Primary completion
Apr 22, 2021
Completion
Apr 22, 2021
Last update
Mar 1, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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