24 Month Follow-up of Patients With Osgood Schlatter (OSD)

Osgood-Schlatter Disease Clinical Trial

Official title:

A Prospective Investigation of Osgood Schlatter With 24 Month Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03589001
• Other study ID #: N-20140100-5
• Status: Completed
• Start date: July 10, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: July 2019
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Osgood Schlatter is a common knee condition, affecting approximately 10% of adolescents. OSD is thought to be a growth related pain conditon, and thus resolve after maturation. Despite this, there a lack of prospective data investigating whether this is in fact the case.

Description:

This is a prospective cohort study of 51 adolescents (aged 10-14 at baseline) with Osgood schlatter. Participants are followed for two years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 28, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 14 Years

Eligibility

Inclusion Criteria:

• 10-14 years of age

• Pain at tibial tuberosity during two or more of the following activities: Sitting with a bent knee, squatting, running, jumping or stair ambulation

• Pain during palpation of tibial tuberosity

• Knee pain for 6 weeks or more

Exclusion Criteria:

• Other knee conditions that may manifest as anterior knee pain (Patellofemoral pain, iliotibial band syndrome, sinding-larson-johanson disease).

• Previous surgery

• Pain from the hip or back that interferes with activities of daily living.

• Habitual patella luxations

• Clinical suspicion of meniscal lesion

Related Conditions & MeSH terms

• Apophysitis
• Osgood-Schlatter Disease

Intervention

Other:
• Activity modification
Activity modification, exercises and gradual return to sport

Locations

Country	Name	City	State
Denmark	Research Unit for General Practice in Aalborg	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Current knee pain	Participants self-report if they still have knee pain	24 months
Secondary	Pain intensity	Worst pain in the previous week measured on a visual analogue scale (VAS) from 'no pain' to 'worst imaginable pain'	24 months
Secondary	Pain frequency	Frequency of knee pain divided into (almost daily, several times per week, weekly, monthly, rarely, never)	24 months
Secondary	Duration of being pain-free	Those who no longer have knee pain will be asked how long since their knee pain resoved	24 months
Secondary	Medical attention	Participants will be asked to report if they sought medical attention outside of the intervention	24 months
Secondary	Use of pain killers	Participants will be asked if they use painkillers to manage their knee pain (y/n). If yes, they will be asked how often.	24months
Secondary	knee injury and osteoarthritis outcomes score (KOOS) sport and activity subscale	knee injury and osteoarthritis outcomes score (KOOS) subscale sport and activity. Minimum 0 points, maximum 100points, with 100 points being the best possible score.	24 months
Secondary	Sports participation	Participants will report if they participate in sport. If yes how often and how much/week. They will also report if they have reduced sports participation due to knee pain.	24 months
Secondary	Health Related quality of life	Health related quality of life assessed by EQ 5D 3L Y (EuroQol, 5 dimensions, 3 levels for youth). Minimum 0, maximum 1, with higher values indicating higher quality of life.	24 months
Secondary	Sleep	Participants will be asked if they find it hard to sleep because of their knee pain (not at all, some nights, most nights).	24 months