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.

Study Overview

• Status: Completed
• Conditions: Lower Limb Apophysitis (Severs, Osgood Schlatter, Sinding-Larsen Johansson)

• Study Type: Observational
• Enrollment (Actual): 1218

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Kasper Krommes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical and mental health	SF-12 (Short-form 12 item) health survey	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep: problems and duration		Baseline
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
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
KOOS subscales	Knee injury and Osteoarthritis Outcome Score (KOOS) and its 5 subscale each scoring 0-100, with 100 being the no problems.	Baseline
Number of Comorbidities from National Health Survey. and musculoskeletal diagnoses from knee or heel		Baseline
PAS-2	Physical activtiy scale	Baseline

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2021
• Primary Completion (Actual): April 22, 2021
• Study Completion (Actual): April 22, 2021

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (Actual): March 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Osteitis
• Other Study ID Numbers: 123456789 (Bandirma Onyedi Eylul University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The full dataset, excluding all personal identifiers, will be posted alongside the pre-print when the results have been disseminated.
• IPD Sharing Time Frame: After primary publication and for the foreseeable futures thereafter.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No