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

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

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.

Study Overview

• Status: Completed
• Conditions: Apophysitis; Osgood-Schlatter Disease
• Intervention / Treatment: Other: Activity modification

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9220 Ø
    • Research Unit for General Practice in Aalborg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adolescents aged 10-14 years old diagnosed with Osgood Schlatter

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OSD; 51 adolescents with Osgood Schlatter who participated in an activity modification intervention.	Other: Activity modification; Activity modification, exercises and gradual return to sport

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Current knee pain	Participants self-report if they still have knee pain	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Worst pain in the previous week measured on a visual analogue scale (VAS) from 'no pain' to 'worst imaginable pain'	24 months
Pain frequency	Frequency of knee pain divided into (almost daily, several times per week, weekly, monthly, rarely, never)	24 months
Duration of being pain-free	Those who no longer have knee pain will be asked how long since their knee pain resoved	24 months
Medical attention	Participants will be asked to report if they sought medical attention outside of the intervention	24 months
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Aalborg University

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2018
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: July 3, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (Actual): July 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 2, 2019
• Last Update Submitted That Met QC Criteria: July 1, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Osteochondrosis
• Other Study ID Numbers: N-20140100-5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: IPD will be shared upon reasonable request, inline with Data Protection procedures

Drug and device information, study documents

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