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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04313621
Other study ID # 123456789
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 8, 2021
Est. completion date April 22, 2021

Study information

Verified date February 2023
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1218
Est. completion date April 22, 2021
Est. primary completion date April 22, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms

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

Locations

Country Name City State
Denmark Kasper Krommes Hvidovre

Sponsors (1)

Lead Sponsor Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical and mental health SF-12 (Short-form 12 item) health survey Baseline
Secondary Sleep: problems and duration Baseline
Secondary 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 Baseline
Secondary 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 Baseline
Secondary KOOS subscales Knee injury and Osteoarthritis Outcome Score (KOOS) and its 5 subscale each scoring 0-100, with 100 being the no problems. Baseline
Secondary Number of Comorbidities from National Health Survey. and musculoskeletal diagnoses from knee or heel Baseline
Secondary PAS-2 Physical activtiy scale Baseline