Lower Limb Apophysitis (Severs, Osgood Schlatter, Sinding-Larsen Johansson) Clinical Trial
Official title:
Management of Lower Limb Apophysitis: A Cross-sectional Study on Long-term Impact on Health Status
| 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 |
| Verified date | February 2023 |
| Source | Hvidovre University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Kasper Krommes | Hvidovre |
| Lead Sponsor | Collaborator |
|---|---|
| Hvidovre University Hospital |
Denmark,
| 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 |