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

Completed

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

• Registration Number: NCT04313621
• Lead Sponsor: Hvidovre University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-17
• Study First Submitted QC: 2020-03-17
• Study First Posted: 2020-03-18
• Study Start: 2021-04-08
• Primary Completion: 2021-04-22
• Study Completion: 2021-04-22
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1218

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physical and mental health	Baseline	SF-12 (Short-form 12 item) health survey

Secondary Outcome Measures

Name	Time	Method
Knee pain	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
Sleep: problems and duration	Baseline
Self-reported level of satisfaction with participation in physical activity and sports	Baseline	Tegner activity scale (0-10, 10 being no physical activity) and individual specific specific questions
KOOS subscales	Baseline	Knee injury and Osteoarthritis Outcome Score (KOOS) and its 5 subscale each scoring 0-100, with 100 being the no problems.
PAS-2	Baseline	Physical activtiy scale
Number of Comorbidities from National Health Survey. and musculoskeletal diagnoses from knee or heel	Baseline

Trial Locations

Locations (1)

Kasper Krommes; 🇩🇰 Hvidovre, Denmark