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OpenTrials
Completed

NCT Number: NCT04313621

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

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.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kasper Krommes

Hvidovre, 2650, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • Diseased participants will be censored

Treatment and study plan

Primary outcomes

  1. Physical and mental health

    Time frame: Baseline

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

Secondary outcomes

  1. Sleep: problems and duration

    Time frame: Baseline

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

    Time frame: Baseline

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

  3. Knee pain

    Time frame: Baseline

    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

  4. KOOS subscales

    Time frame: Baseline

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

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

    Time frame: Baseline

  6. PAS-2

    Time frame: Baseline

    Physical activtiy scale

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 18, 2020
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.